As filed with the Securities and Exchange Commission on August 17, 2007
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
CardioNet, Inc.
(Exact name of registrant as specified in its charter)
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California
(State or other jurisdiction of incorporation or organization) |
8090
(Primary Standard Industrial Classification Code Number) |
33-0604557
(I.R.S. Employer Identification Number) |
1010 Second Avenue
San Diego, California 92101
(619) 243-7500
(Address, including zip code, and telephone number, including
area code, of registrant's principal executive offices)
James M. Sweeney
Chief Executive Officer and Chairman
CardioNet, Inc.
1010 Second Avenue
San Diego, California 92101
(619) 243-7500
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Copies to:
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Frederick T. Muto, Esq.
Ethan E. Christensen, Esq. Cooley Godward Kronish LLP 4401 Eastgate Mall San Diego, California 92121 (858) 550-6000 |
Donald J. Murray, Esq.
Dewey Ballantine LLP 1301 Avenue of the Americas New York, New York 10019 (212) 259-8000 |
Approximate date of commencement of proposed sale to the public:
As soon as practicable after the effective date of this registration statement.
If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended (the "Securities Act"), check the following box. o
If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o
If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o
If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration number of the earlier effective registration statement for the same offering. o
CALCULATION OF REGISTRATION FEE
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Title of each class of
securities to be registered |
Proposed maximum
aggregate offering price(1) |
Amount of
registration fee |
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| Common Stock, $0.001 par value per share | $150,000,000 | $4,605 | ||
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The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment that specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.
The information in this preliminary prospectus is not complete and may be changed. Neither we nor the selling stockholders may sell or accept an offer to buy these securities under this preliminary prospectus until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities, and neither we nor the selling stockholders are soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.
Subject to completion, dated August 17, 2007
PROSPECTUS
Shares
Common Stock
CardioNet, Inc. is selling shares of common stock. This is the initial public offering of our common stock. The selling stockholders included in this prospectus are selling an additional shares of common stock. We will not receive any proceeds from the sale of shares of common stock by the selling stockholders. The estimated initial public offering price is between $ and $ per share.
Prior to this offering, there has been no public market for our common stock. We have applied for listing on the Nasdaq Global Market under the symbol "BEAT."
Investing in our common stock involves a high degree of risk. See "Risk Factors" beginning on page 11.
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Per share
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Total
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| Initial public offering price | $ | $ | ||||
| Underwriting discounts and commissions | $ | $ | ||||
| Proceeds to CardioNet, before expenses | $ | $ | ||||
| Proceeds to selling stockholders, before expenses | $ | $ | ||||
We have granted the underwriters an option for a period of 30 days to purchase up to additional shares of common stock on the same terms and conditions set forth above to cover over-allotments, if any.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed on the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
The underwriters expect to deliver the shares of common stock to investors on , .
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CIBC World Markets |
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SunTrust Robinson Humphrey |
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Page
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| PROSPECTUS SUMMARY | 1 | |
| RISK FACTORS | 11 | |
| FORWARD-LOOKING STATEMENTS | 28 | |
| USE OF PROCEEDS | 29 | |
| DIVIDEND POLICY | 30 | |
| CAPITALIZATION | 31 | |
| DILUTION | 33 | |
| UNAUDITED PRO FORMA CONSOLIDATED STATEMENTS OF OPERATIONS | 35 | |
| SELECTED CONSOLIDATED FINANCIAL DATA | 40 | |
| MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS | 42 | |
| BUSINESS | 55 | |
| MANAGEMENT | 79 | |
| EXECUTIVE COMPENSATION | 85 | |
| RELATED PARTY TRANSACTIONS | 102 | |
| PRINCIPAL AND SELLING STOCKHOLDERS | 105 | |
| DESCRIPTION OF CAPITAL STOCK | 108 | |
| MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS | 114 | |
| SHARES ELIGIBLE FOR FUTURE SALE | 117 | |
| UNDERWRITING | 120 | |
| LEGAL MATTERS | 124 | |
| EXPERTS | 124 | |
| WHERE YOU CAN FIND ADDITIONAL INFORMATION | 125 | |
| INDEX TO CONSOLIDATED FINANCIAL STATEMENTS | F-1 |
You should rely only on the information contained in this prospectus and any free writing prospectus prepared by or on behalf of us or to which we have referred you. We have not authorized anyone to provide you with different information. We and the selling stockholders are offering to sell, and seeking offers to buy, common stock only in jurisdictions where offers and sales are permitted. The information contained in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or of any sale or our common stock.
No action is being taken in any jurisdiction outside the United States to permit a public offering of the common stock or possession or distribution of this prospectus in that jurisdiction. Persons who come into possession of this prospectus in jurisdictions outside the United States are required to inform themselves about and to observe any restrictions as to this offering and the distribution of this prospectus applicable to that jurisdiction.
Through and including , (25 days after the commencement of this offering), all dealers that buy, sell or trade in our common stock, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to the dealer's obligation to deliver a prospectus when acting as an underwriter and with respect to their unsold allotments or subscriptions.
i
Unless the context indicates otherwise, as used in this prospectus, the terms "CardioNet," "we," "us" and "our" refer to CardioNet, Inc., a Delaware corporation, and its subsidiaries taken as a whole, unless otherwise noted.
We use "CardioNet" and "PDSHeart" as registered trademarks in the United States. This prospectus also includes references to trademarks and service marks of other entities, and those trademarks and service marks are the property of their respective owners.
We are a California company. We intend to reincorporate in Delaware prior to the consummation of the offering.
ii
This summary highlights what we believe is the most important information about us and this offering. Because it is only a summary, it does not contain all of the information that you should consider before investing in shares of our common stock. The information in this summary is qualified in its entirety by, and should be read in conjunction with, the more detailed information appearing elsewhere in this prospectus. Before you decide to invest in our common stock, you should read this entire prospectus carefully, including the "Risk Factors" and the consolidated financial statements and related notes included in this prospectus.
Overview
We are the leading provider of ambulatory, continuous, real-time outpatient management solutions for monitoring relevant and timely clinical information regarding an individual's health. We have raised over $200 million of capital and spent seven years developing a proprietary integrated patient monitoring platform that incorporates a wireless data transmission network, internally developed software, FDA cleared algorithms and medical devices, and a 24-hour digital monitoring service center. Our initial efforts are focused on the diagnosis and monitoring of cardiac arrhythmias, or heart rhythm disorders, with a solution that we market as the CardioNet System.
We believe that the CardioNet System's continuous, heartbeat-by-heartbeat monitoring is a fundamental advancement in arrhythmia monitoring, with the potential to transform an industry that has historically relied on memory-constrained, intermittent digital or tape recorders, such as event monitors and Holter monitors. Existing technologies have one or more drawbacks including the inability to detect asymptomatic events, which are defined as clinically significant events that the patient cannot feel, algorithms with limited detection capabilities, failure to provide real-time data, memory constraints, frequent inaccurate diagnoses and an inability to monitor patient compliance and interaction. We believe these drawbacks lead to suboptimal diagnostic yields, which adversely impact clinical outcomes and health care costs. In a recently completed randomized clinical trial, the CardioNet System detected clinically significant arrhythmias nearly three times as often as traditional loop event monitors in patients who had previously experienced negative or nondiagnostic Holter monitoring.
The CardioNet System incorporates a lightweight patient-worn sensor attached to electrodes that capture two-lead electrocardiogram, or ECG, data measuring electrical activity of the heart and communicates wirelessly with a compact, handheld monitor. The monitor analyzes incoming heartbeat-by-heartbeat information from the sensor on a real-time basis by applying proprietary algorithms designed to detect arrhythmias. When the monitor detects an arrhythmic event, it automatically transmits the ECG to the CardioNet Monitoring Center, even in the absence of symptoms experienced by the patient and without patient involvement. At the CardioNet Monitoring Center, which operates 24 hours a day and 7 days per week, experienced certified cardiac monitoring specialists analyze the sent data, respond to urgent events and report results in the manner prescribed by the physician. The CardioNet System currently stores 96 hours of ECG data, in contrast to 10 minutes for a typical event monitor. We are in the process of upgrading our monitors to provide expanded storage of 21 days of ECG data. The CardioNet System employs two-way wireless communications, enabling continuous transmission of patient data to the CardioNet Monitoring Center and permitting physicians to remotely adjust monitoring parameters and request previous ECG data from the memory stored in the monitor.
Since our commercial introduction of the CardioNet System in January 2003, physicians have enrolled over 80,000 patients. Through the end of 2006, we marketed our solution in select territories, principally in 23 states in the Mid-Atlantic, Northeast and Midwest. In addition, we have achieved reimbursement levels that we believe reflects the clinical efficacy of the CardioNet System relative to
1
existing technologies. We have secured direct contracts with 154 commercial payors which, combined with Medicare, represents more than 154 million covered lives as of June 30, 2007.
Recent Developments
Industry Overview
An arrhythmia is categorized as a temporary or sustained abnormal heart rhythm that is caused by a disturbance in the electrical signals in the chambers of the heart. Proper administration of electrical signals through the heart is necessary to ensure effective heart function. There are two main categories of arrhythmia: tachycardia, meaning too fast a heartbeat, and bradycardia, meaning too slow a heartbeat.
Arrhythmias affect more than 4 million people in the United States. According to the American Heart Association, arrhythmias result in more than 780,000 hospitalizations and contribute to more than 480,000 deaths per year.
The ability to diagnose or rule out an arrhythmia as a symptom of a cardiac condition is important both to treat those patients with serious cardiovascular diseases as well as to identify those patients that may not require further medical attention. Arrhythmias may be diagnosed either in a physician's office or other health care facility or remotely by monitoring a patient's heart rhythm. Typically, physicians
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will initially administer a resting ECG that monitors the electrical impulses in a patient's heart. If a physician determines that a patient needs to be monitored for a longer period of time to produce a diagnosis, the physician will typically prescribe an ambulatory cardiac monitoring device, such as a Holter monitor or an event monitor.
Event monitors offer certain advantages over Holters given that they are worn over a period of up to 30 days, instead of the one or two day Holter period. However, event monitors have significant shortcomings. Manual-trigger loop event monitors capture only cardiac events associated with symptoms detectable by the patient and not asymptomatic cardiac events. We believe that only 15% to 20% of clinically significant cardiac events are symptomatic, meaning that the patient can feel them as they occur. Other drawbacks of manual-trigger loop event monitors include the limited data storage, the lack of trend data, and poor patient compliance relating to the requirement that the patient must both trigger and transmit events.
A newer version of event monitoring devices was introduced in 1999 called auto-detect loop event monitors, which incorporate basic algorithms that look at fast, slow or irregular heart rates and in some cases, pauses, to automatically detect certain asymptomatic arrhythmias. The primary drawback of auto-detect loop event monitors is that they require the patient to call in to transmit data to physicians. The latest development in event monitoring is referred to as auto-detect/auto-send loop event monitors, which have the ability to send captured event data to a monitoring center via cell phone. The drawbacks of auto-detect/auto-send loop event monitors are that they suffer from limited data storage and, to our knowledge, utilize algorithms that were not subject to the same level of FDA scrutiny prior to marketing as the CardioNet System.
Despite major advances in cardiology with new therapeutic drugs, such as beta blockers and statins, and new therapeutic devices and procedures over the last several decades, there have been few advances in ambulatory monitoring. We believe that there is a significant opportunity for new arrhythmia monitoring solutions that exploit the convergence of wireless, low power microelectronic
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and software technologies to address the shortcomings of traditional Holter and event monitors. These shortcomings often lead to suboptimal diagnostic yields which adversely impact clinical outcomes and health care costs.
CardioNet Solution
We have developed an ambulatory, continuous and real-time arrhythmia monitoring solution that we believe represents a significant advancement over event and Holter monitoring. The CardioNet System incorporates a patient-worn sensor attached to electrodes that capture two-lead ECG data and communicates wirelessly with a compact monitor that analyzes incoming information by applying proprietary algorithms designed to detect arrhythmias and eliminate data noise. When the monitor detects an arrhythmic event, it automatically transmits the ECG data to the CardioNet Monitoring Center, where experienced certified cardiac monitoring specialists analyze the sent data, respond to urgent events and report results in the manner prescribed by the physician. The CardioNet System, on average, is worn by the patient for a period of approximately 14 days.
The CardioNet System results in a high diagnostic yield of clinically significant arrhythmias, allowing for real-time detection and analysis as well as timely intervention and treatment by the physician. In a recently completed randomized 300-patient clinical study, the CardioNet System detected clinically significant arrhythmias nearly three times as often as traditional loop event monitors in patients who have previously experienced negative or nondiagnostic Holter monitoring or 24 hours of telemetry.
We believe that the CardioNet System offers the following advantages to physicians, payors and patients:
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Our Business Strategy
Our goal is to maintain our position as the leading provider of ambulatory, continuous and real-time outpatient monitoring services by establishing our proprietary integrated technology and service offering as the standard of care for multiple health care markets. The key elements of the business strategy by which we intend to achieve these goals include:
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Risks Affecting Us
We are subject to a number of risks that you should be aware of before you buy our common stock, including:
These and other risks are discussed more fully in the "Risk Factors" section of this prospectus.
Corporate Information
We were incorporated in the State of California in March 1994. We will reincorporate in the State of Delaware prior to the consummation of this offering. Our principal executive offices are located at 1010 Second Avenue, San Diego, California 92101, and our telephone number is (619) 243-7500. Our website address is www.cardionet.com . The information contained in, or that can be accessed through, our website is not part of this prospectus.
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| Common stock offered by CardioNet | shares | |
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Common stock offered by the selling stockholders |
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shares |
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Over-allotment option |
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We and the selling stockholders have granted the underwriters an option for a period of 30 days to purchase up to additional shares of common stock |
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Common stock to be outstanding after this offering |
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shares, assuming an initial public offering price of $ per share, the mid-point of the price range set forth on the cover page of this prospectus. |
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Use of proceeds. |
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We intend to use the net proceeds to us from this offering (i) to repay a term loan with and to pay a success fee to Silicon Valley Bank, (ii) to make payments to former stockholders of PDSHeart, (iii) for research and development, to build our inventory of future generations of the CardioNet Systems, increase our sales and marketing capabilities for our CardioNet System, hire additional personnel, invest in infrastructure and pursue new markets and geographies, (iv) to acquire or license products, technologies or businesses, and (v) for working capital and general corporate purposes. We will not receive any of the proceeds from the sale of common stock by the selling stockholders. See "Use of Proceeds." |
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Proposed symbol on The Nasdaq Global Market |
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BEAT |
The share amounts listed here are based on shares outstanding as of June 30, 2007. These amounts exclude:
Unless otherwise noted, the information in this prospectus assumes:
7
The number of shares of our common stock issuable upon conversion of our mandatorily redeemable convertible preferred stock and upon exercise of warrants to purchase shares of our Series D-1 preferred stock, which convert into shares of common stock, will vary based on the initial public offering price of our common stock in this offering. The number of shares of our common stock outstanding after this offering would be shares if the initial public offering price is $ per share, the low end of the price range set forth on the cover page of this prospectus, and shares if the initial public offering price is $ per share, the high end of the price range set forth on the cover page of this prospectus. See "Capitalization" and "Description of Capital Stock."
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Summary Consolidated Financial Information
The following summary consolidated financial data should be read together with our consolidated financial statements and related notes and "Management's Discussion and Analysis of Financial Condition and Results of Operations" appearing elsewhere in this prospectus. The summary consolidated financial data for the years ended December 31, 2004, 2005 and 2006 are derived from our audited financial statements, which are included elsewhere in this prospectus. The summary consolidated financial data for the six months ended June 30, 2006 and 2007 and at June 30, 2007 are derived from our unaudited consolidated financial statements, which are included elsewhere in this prospectus.
The summary unaudited pro forma consolidated statements of operations data for the year ended December 31, 2006 and the six months ended June 30, 2007 are based on the historical statements of operations of CardioNet, Inc. and PDSHeart, Inc., giving effect to our acquisition of PDSHeart as if the acquisition had occurred on January 1, 2006 and January 1, 2007, respectively. The summary unaudited pro forma consolidated statement of operations data is based on the estimates and assumptions set forth in the notes to the unaudited pro forma consolidated statement. These estimates and assumptions are preliminary and subject to change, and have been made solely for the purposes of developing such pro forma information. The summary unaudited pro forma consolidated statement of operations data is presented for illustrative purposes only and are not necessarily indicative of the combined results of operations to be expected in any future period or the results that actually would have been realized had the entities been a single entity during these periods.
The as adjusted balance sheet data reflects the balance sheet data at June 30, 2007, as adjusted for the sale by us of shares of our common stock in this offering at an assumed initial offering price to the public of $ per share, after deducting the estimated underwriting discounts, commissions and offering expenses payable by us.
We have prepared the summary unaudited consolidated financial data set forth below on the same basis as our audited financial statements and have included all adjustments, consisting only of normal recurring adjustments, that we consider necessary for a fair presentation of our financial position and operating results for such periods. The pro forma basic net loss per share data are unaudited and give effect to the conversion into common stock of all outstanding shares of our preferred stock for the periods indicated. The interim results set forth below are not necessarily indicative of results for future periods.
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Year ended December 31,
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Six months ended June 30,
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(in thousands, except share and per share data)
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| Statement of Operations Data: | |||||||||||||||||||||||
| Revenues: | |||||||||||||||||||||||
| Net patient revenues | $ | 20,956 | $ | 29,467 | $ | 33,019 | $ | 53,700 | $ | 15,516 | $ | 28,221 | $ | 32,276 | |||||||||
| Other revenues | 1,275 | 1,471 | 904 | 1,075 | 632 | 299 | 313 | ||||||||||||||||
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| Total revenues | 22,231 | 30,938 | 33,923 | 54,775 | 16,148 | 28,520 | 32,589 | ||||||||||||||||
| Cost of revenues | 16,971 | 16,963 | 12,701 | 20,194 | 6,866 | 9,743 | 11,389 | ||||||||||||||||
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| Gross profit | 5,260 | 13,975 | 21,222 | 34,581 | 9,283 | 18,776 | 21,200 | ||||||||||||||||
| Operating expenses: | |||||||||||||||||||||||
| Research and development | 2,412 | 3,361 | 3,631 | 3,631 | 1,980 | 2,010 | 2,010 | ||||||||||||||||
| General and administrative | 15,252 | 13,853 | 15,631 | 22,064 | 7,462 | 11,974 | 13,014 | ||||||||||||||||
| Sales and marketing | 7,695 | 6,456 | 6,448 | 11,304 | 2,979 | 7,696 | 8,758 | ||||||||||||||||
| Amortization | | | | 985 | | 307 | 493 | ||||||||||||||||
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| Total operating expenses | 25,359 | 23,670 | 25,710 | 37,984 | 12,422 | 21,987 | 24,275 | ||||||||||||||||
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| Loss from operations | (20,099 | ) | (9,695 | ) | (4,488 | ) | (3,403 | ) | (3,139 | ) | (3,211 | ) | (3,075 | ) | |||||||||
| Other income (expense): | |||||||||||||||||||||||
| Interest income | 141 | 97 | 114 | 132 | 42 | 905 | 910 | ||||||||||||||||
| Interest expense | (989 | ) | (1,539 | ) | (2,341 | ) | (2,713 | ) | (1,047 | ) | (1,314 | ) | (1,356 | ) | |||||||||
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| Total other expense | (848 | ) | (1,442 | ) | (2,226 | ) | (2,581 | ) | (1,005 | ) | (409 | ) | (446 | ) | |||||||||
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| Net loss | (20,947 | ) | (11,137 | ) | (6,714 | ) | (5,984 | ) | (4,143 | ) | (3,620 | ) | (3,521 | ) | |||||||||
| Dividends on and accretion of mandatorily redeemable convertible preferred stock | | | | | | (2,844 | ) | (2,844 | ) | ||||||||||||||
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| Net loss applicable to common shares | $ | (20,947 | ) | $ | (11,137 | ) | $ | (6,714 | ) | $ | (5,984 | ) | $ | (4,143 | ) | $ | (6,464 | ) | $ | (6,365 | ) | ||
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| Basic and diluted net loss per share(1): | |||||||||||||||||||||||
| Historical | $ | (3.67 | ) | $ | (1.96 | ) | $ | (1.15 | ) | $ | (0.72 | ) | $ | (1.04 | ) | ||||||||
| Pro Forma | $ | (0.25 | ) | $ | (0.19 | ) | |||||||||||||||||
| Shares used to compute basic and diluted net loss per share(1): | |||||||||||||||||||||||
| Historical | 5,712,144 | 5,675,544 | 5,816,719 | 5,751,700 | 6,214,067 | ||||||||||||||||||
| Pro Forma | 23,619,018 | 33,673,580 | |||||||||||||||||||||
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As of June 30, 2007
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As Adjusted(2)
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| Summary Consolidated Balance Sheet Data: | ||||||
| Cash and cash equivalents | $ | 50,334 | $ | |||
| Working capital | 32,766 | |||||
| Total assets | 121,573 | |||||
| Total debt | 26,544 | |||||
| Mandatorily redeemable convertible preferred stock | 109,802 | |||||
| Total shareholders' deficit | $ | (79,880 | ) | $ | ||
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Before you decide to invest in our common stock, you should consider carefully the risks described below, together with the other information contained in this prospectus. We believe the risks described below are the risks that are material to us as of the date of this prospectus. If any of the following risks comes to fruition, our business, financial condition, results of operations and future growth prospects would likely be materially and adversely affected. In these circumstances, the market price of our common stock could decline, and you may lose all or part of your investment.
Risks related to our business and industry
We have a history of net losses and may never become profitable.
We have incurred net losses from our inception through June 30, 2007, including net losses of $11.1 million for the year ended December 31, 2005, $6.7 million for the year ended December 31, 2006 and $3.6 million for the six months ended June 30, 2007. As of June 30, 2007, we had total shareholders' deficit of approximately $79.9 million. We expect our operating expenses to increase as we, among other things:
With increasing expenses, we will need to substantially increase our revenues to become profitable. Because of the risks and uncertainties associated with further developing and marketing the CardioNet System, we are unable to predict the extent of any future losses or when we will become profitable, if at all.
Our business is dependent upon physicians prescribing our services; if we fail to obtain those prescriptions, our revenues could fail to grow and could decrease.
The success of our business is dependent upon physicians prescribing our services for patients and cross-selling the respective Company and PDSHeart customer bases. Our success in obtaining prescriptions and cross-selling will be directly influenced by a number of factors, including:
If we are unable to educate physicians regarding the benefits of the CardioNet System, obtain sufficient prescriptions and cross-sell our respective customer bases, revenues from the provision of our arrhythmia monitoring solutions could fail to grow and could decrease.
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We and the physicians with whom we work are dependent upon reimbursement for the fees associated with our services; the absence or inadequacy of reimbursement would cause our revenues to fail to grow or decrease.
We receive reimbursement for our services from commercial payors and from Medicare Part B carriers where the services are performed on behalf of the Centers for Medicare and Medicaid Services, or CMS. The Medicare Part B carriers in each state change from time to time, which may result in changes to our reimbursement rates, increased administrative burden and reimbursement delays.
In addition, our physician customers receive reimbursement for professional interpretation of the information provided by our products and services from commercial payors or Medicare carriers within the state where they practice. The efficacy, safety, performance and cost-effectiveness of our products and services, on a stand-alone basis and relative to competing services, will determine the availability and level of reimbursement we and our physician customers receive. Our ability to successfully contract with payors is critical to our business because physicians and their patients will select arrhythmia monitoring solutions other than ours in the event that payors refuse to adequately reimburse our technical fees and physicians' professional fees.
Many commercial payors refuse to enter into contracts to reimburse the fees associated with medical devices or services that such payors determine to be "experimental and investigational." Commercial payors typically label medical devices or services as "experimental and investigational" until such devices or services have demonstrated product superiority evidenced by a randomized clinical trial. We recently completed a clinical trial in which the CardioNet System provided higher diagnostic yield than traditional loop event monitoring. Prior to our clinical trial, the CardioNet System was labeled "experimental and investigational" by 21 commercial payors, representing over 95 million covered lives. Subsequent to our trial, three commercial payors, representing over 11 million covered lives removed the designation of the CardioNet System as "experimental and investigational" and several of the remaining payors have informed us that they do not believe the data from this trial justifies the removal of this designation. Other commercial payors may also find the data from our clinical trial not compelling. Additional commercial payors may also label the CardioNet System as "experimental and investigational" and, as a result, refuse to reimburse the technical and professional fees associated with the CardioNet System.
Administration of the claims process for the many commercial payors is complex. As a result we sometimes bill payors for services for which we have no reimbursement contract. These payors may require that we return any funds that they pay in respect of these claims.
If commercial payors or Medicare decide not to reimburse our services or the related services provided by physicians, or the rates of such reimbursement change, or if we fail to properly administer claims, our revenues could fail to grow and could decrease.
Reimbursement by Medicare is highly regulated and subject to change; our failure to comply with applicable regulations, could decrease our revenues and may subject us to penalties or have an adverse impact on our business.
We receive approximately 30% of our revenues as reimbursement from Medicare. The Medicare program is administered by CMS, which imposes extensive and detailed requirements on medical services providers, including, but not limited to, rules that govern how we structure our relationships with physicians, how and when we submit reimbursement claims, how we operate our monitoring facilities and how and where we provide our arrhythmia monitoring solutions. Our failure to comply with applicable Medicare rules could result in discontinuing our reimbursement under the Medicare payment program, our being required to return funds already paid to us, civil monetary penalties, criminal penalties and/or exclusion from the Medicare program.
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In addition, reimbursement from Medicare is subject to statutory and regulatory changes, rate adjustments and administrative rulings, all of which could materially affect the range of services covered or the reimbursement rates paid by Medicare for use of our arrhythmia monitoring solutions. For example, CMS adopted a new payment policy in January 2007 that reduced the rate of reimbursement for a number of services reimbursed by Medicare. Although this modification to Medicare's reimbursement rates did not affect the amount paid by Medicare for reimbursement of the fees associated with the CardioNet System, it resulted in the reduction of reimbursement rates for event services by 3% to 8%, depending on the type of service, and Holter services by 8% as compared to the corresponding rates in effect in 2006. Based on current proposed Medicare rates for 2008 through 2010, we expect that reimbursement for event and Holter services will continue to decline at an annual rate similar to 2007. In addition, we cannot predict whether future modifications to Medicare's reimbursement policies could reduce the amounts we receive from Medicare for the solutions we provide. In addition, Medicare's reimbursement rates can affect the rate that commercial payors are willing to pay for our products and services. Any future limitation or reduction in the reimbursement rates provided by Medicare for our arrhythmia monitoring solutions could result in a reduction in the rates we receive from commercial payors.
Reimbursement for the CardioNet System by Medicare and other commercial payors is complicated by the lack of a specific CPT code, which may result in lower prescription rates or varying reimbursement rates.
When we bill Medicare and certain other commercial payors for the service we provide in connection with the CardioNet System, we submit the bill using the nonspecific billing, or CPT, code "93799." Unlike dedicated CPT codes approved by the American Medical Association, or AMA, and CMS, claims using non-specific codes may require semi-automated or manual processing, as well as additional review by payors. The claims processing requirements associated with a nonspecific code can make our services less attractive to physicians. Furthermore, the Medicare reimbursement rate for non-specific codes is determined by local Medicare carriers. As a result, the reimbursement rates relating to our CardioNet System are subject to change without notice.
A request to the AMA for a specific CPT code that describes our CardioNet System has been made. If this request is approved by the AMA CPT Editorial Panel, the specific CPT code could be available for use in 2009. However, we cannot guarantee that we will receive a specific CPT code for the CardioNet System in that timeframe, or ever. Moreover, if we do receive a CPT code, the reimbursement rate associated with that code, which would be subject to change on an annual basis through a public notice and comment process, may be lower than our current reimbursement rates.
A reduction in sales of our services or a loss of one or more of our key commercial payors would adversely affect our business and operating results.
A small number of commercial payors represent a significant percentage of our revenues. In the year ended December 31, 2006, our top 10 commercial payors by revenues accounted for approximately 37.4% of our total revenues. Our agreements with these commercial payors typically allow either party to the contract to terminate the contract by providing between 60 and 120 days prior written notice to the other party at any time following the end of the initial term of the contract. Our commercial payors may elect to terminate or not to renew their contracts with us for any reason and, in some instances can unilaterally change the reimbursement rates they pay. In the event any of our key commercial payors terminate their agreements with us, elect not to renew their agreements with us or elect not to enter into new agreements with us upon expiration of their agreements with us on terms as favorable as our current agreements, our business, operating results and prospects would be adversely affected.
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Consolidation of commercial payors could result in payors eliminating coverage of our CardioNet System or reduced reimbursement rates for our CardioNet System.
The commercial payor industry is undergoing significant consolidation. When payors combine their operations, the combined company may elect to reimburse our CardioNet System at the lowest rate paid by any of the participants in the consolidation. If one of the payors participating in the consolidation does not reimburse for the CardioNet System at all, the combined company may elect not to reimburse for the CardioNet System. Our reimbursement rates tend to be lower for larger payors. As a result, as payors consolidate, our average reimbursement rate may decline.
Our acquisition of PDSHeart, as well as any other companies or technologies we may acquire in the future, could prove difficult to integrate and may disrupt our business and harm our operating results and prospects.
Our recent acquisition of PDSHeart involves numerous risks, including the risk that we will not take advantage of the cross-selling opportunities brought about by the acquisition. In addition, our acquisition of PDSHeart, as well as acquisitions in which we may engage in the future, involve risks associated with our assumption of the liabilities of an acquired company, which may be liabilities that we were or are unaware of at the time of the acquisition, potential write-offs of acquired assets and potential loss of the acquired company's key employees or customers.
We may encounter difficulties in successfully integrating our operations, technologies, services and personnel with that of the acquired company, and our financial and management resources may be diverted from our existing operations. For example, following our acquisition of PDSHeart we have offices in Pennsylvania, California, Florida, Georgia and Minnesota. Our offices in multiple states creates a strain on our ability to effectively manage our operations and key personnel. If we elect to consolidate our facilities we may loose key personnel unwilling to relocate to the consolidated facility, may have difficulty hiring appropriate personnel at the consolidated facility and may have difficulty providing continuity of service through the consolidation.
Physician and patient satisfaction or performance problems with an acquired business, technology, service or device could also have a material adverse effect on our reputation. Additionally, potential disputes with the seller of an acquired business or its employees, suppliers or customers and amortization expenses related to goodwill and other intangible assets could adversely affect our business, operating results and financial condition.
We may not be able to realize the anticipated benefits of the PDSHeart acquisition or any other acquisition we may pursue or to profitably deploy acquired assets. If we fail to properly evaluate and execute acquisitions, our business may be disrupted and our operating results and prospects may be harmed.
If we are unable to manage our expected growth, our revenues and operating results may be adversely affected.
Our business plans call for rapid expansion of our sales and marketing operations and growth of our research and development, product development and administrative operations. We had a sales force of 27 account executives at December 31, 2006 and 77 account executives at June 30, 2007. We currently intend to expand our sales force to 88 individuals by December 31, 2007. We expect this expansion will place a significant strain on our management and operational and financial resources. Our current and planned personnel, systems, procedures and controls may not be adequate to support our anticipated growth. To manage our growth we will be required to improve existing and implement new operational and financial systems, procedures and controls and expand, train and manage our growing employee base. If we are unable to manage our growth effectively, revenue growth may not be
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realized or may not be sustainable, may not result in improved operating results or earnings, and our business, financial condition and results of operations could be harmed.
Our business is dependent upon having sufficient monitors and sensors. If we do not have enough monitors or sensors or experience delays in manufacturing, we may be unable to fill prescriptions in a timely manner, physicians may elect not to prescribe the CardioNet System, and our revenues and growth prospects could be harmed.
When a physician prescribes the CardioNet System to a patient, our customer service department begins the patient hook-up process, which includes procuring a monitor and sensors from our distribution department and sending them to the patient. While our goal is to provide each patient with a monitor and sensors in a timely manner, we have experienced and may in the future experience delays due to the availability of monitors, primarily when converting to a new generation of monitor or, more recently, in connection with the increase in prescriptions following our acquisition of PDSHeart.
We may also experience shortages of monitors or sensors due to manufacturing difficulties. Multiple suppliers provide the components used in the CardioNet System, but our facilities in San Diego, California are registered and approved by the United States Food and Drug Administration, or FDA, as the ultimate manufacturer of the CardioNet System. Our manufacturing operations could be disrupted by fire, earthquake or other natural disaster, a work stoppage or other labor-related disruption, failure in supply or other logistical channels, electrical outages or other reasons. If there was a disruption to our facilities in San Diego, we would be unable to manufacture the CardioNet System until we have restored and re-qualified our manufacturing capability or developed alternative manufacturing facilities.
We are currently in the process of developing the next generation of the CardioNet System, called C3, which will feature several technology enhancements. We expect that we will begin filling prescriptions with the C3 monitors and sensors in the second half of 2007. In order to produce the quantities of the C3 that we believe will be required to meet anticipated market demand, we will need to increase our C3 manufacturing capacity significantly over the current level. There are technical challenges to increasing manufacturing capacity, including the investment of substantial funds and hiring and retaining management and technical personnel who have the necessary manufacturing experience. We may not successfully complete this process in a timely manner or at all. If we are unable to do so, we would not be able to produce sufficient quantities of our next generation C3 monitors and sensors to satisfy anticipated demand and to replace our inventory of existing monitors and sensors prior to their obsolescence.
Our primary manufacturer of components for the CardioNet System has announced the closing of its facility near San Diego, California where it was manufacturing these components. Following the closing of this facility, all monitor and sensor production will take place at its facility in Tempe, Arizona. The transfer of production to the new production facility poses several risks to our supply of CardioNet System monitors, including potential issues related to the quality of our monitors and sensors, training of a new workforce and production shortages and delays.
Our success in obtaining future prescriptions from physicians is dependent upon our ability to promptly deliver monitors and sensors to our patients, and a failure in this regard would have an adverse effect on our revenues and growth prospects.
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Interruptions or delays in telecommunications systems or in the data services provided to us by QUALCOMM or the loss of our wireless or data services could impair the delivery of our CardioNet System services.
The success of the CardioNet System is dependent upon our ability to store, retrieve, process and manage data and to maintain and upgrade our data processing and communication capabilities. The monitors we use in connection with the CardioNet System rely on a third party wireless carrier to transmit data over its data network during times that the monitor is removed from its base. All data sent by our monitors via this wireless data network or via landline is routed directly to QUALCOMM data centers and subsequently routed to our monitoring center. We are dependent upon these third parties to provide data transmission and data hosting services to us. We do not have an agreement directly with this third party wireless carrier. Although we do have an agreement with QUALCOMM that has an initial termination date in September 2010, QUALCOMM may terminate their agreement with us if certain conditions occur, including if QUALCOMM's agreement with the third party wireless carrier terminates. If we fail to maintain our relationships with QUALCOMM or if we lose our wireless carrier services, we would be forced to seek alternative providers of data transmission and data hosting services, which might not be available on commercially reasonable terms or at all.
As we expand our commercial activities, an increased burden will be placed upon our data processing systems and the equipment upon which they rely. Interruptions of our data networks or the data networks of QUALCOMM for any extended length of time, loss of stored data or other computer problems could have a material adverse effect on our business, financial condition and results of operations. Frequent or persistent interruptions in our arrhythmia monitoring services could cause permanent harm to our reputation and could cause current or potential users of the CardioNet System to believe that our systems are unreliable, leading them to switch to our competitors. Such interruptions could result in liability, claims and litigation against us for damages or injuries resulting from the disruption in service.
Our systems are vulnerable to damage or interruption from earthquakes, floods, fires, power loss, telecommunication failures, terrorist attacks, computer viruses, break-ins, sabotage, and acts of vandalism. Despite any precautions that we may take, the occurrence of a natural disaster or other unanticipated problems could result in lengthy interruptions in these services. We do not carry business interruption insurance to protect against losses that may result from interruptions in service as a result of system failures. Moreover, the communications and information technology industries are subject to rapid and significant changes, and our ability to operate and compete is dependent in significant part on our ability to update and enhance the communication technologies used in our systems and services.
The market for arrhythmia monitoring solutions is highly competitive. If our competitors are better able to develop or market monitoring solutions that are more effective, or gain greater acceptance in the marketplace, than any solutions we develop, our commercial opportunities will be reduced or eliminated.
The market for arrhythmia monitoring solutions is evolving rapidly and becoming increasingly competitive. Our industry is highly fragmented and characterized by a small number of large providers and a large number of smaller regional service providers. These third parties compete with us in recruiting and retaining qualified personnel, acquiring technology and developing solutions complementary to our programs. In addition, as companies with substantially greater resources than ours enter our market, we will face increased competition. If our competitors are better able to develop and patent arrhythmia monitoring solutions than us, or develop more effective and/or less expensive arrhythmia monitoring solutions that render our solutions obsolete or non-competitive or deploy larger or more effective marketing and sales resources than ours, our business will be harmed and our commercial opportunities will be reduced or eliminated.
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If we need to raise additional funding in the future, we may be unable to raise such capital when needed, or at all, and the terms of such capital may be adverse to our stockholders.
We believe that the net proceeds from this offering, together with our existing cash and cash equivalent balances, will be sufficient to meet our anticipated cash requirements for the foreseeable future. However, our future funding requirements will depend on many factors, including:
If we need to, or choose to, raise additional capital in the future, such capital may not be available on reasonable terms, or at all. If we raise additional funds by issuing equity securities, substantial dilution to existing stockholders would likely result. If we raise additional funds by incurring additional debt financing, the terms of the debt may involve significant cash payment obligations as well as covenants and financial ratios that may restrict our ability to operate our business.
Our manufacturing facilities and the manufacturing facilities of our suppliers must comply with applicable regulatory requirements. If we or our suppliers fail to achieve or maintain regulatory approval of these manufacturing facilities, our growth could be limited and our business could be harmed.
We currently manufacture the monitors and sensors for the CardioNet System in San Diego, California. Monitors used in the provision of services by PDSHeart are purchased from several third parties. Our manufacturing facilities must be evaluated and qualified under a quality system to ensure they meet production and quality standards. Suppliers of components of and products used to manufacture the CardioNet System and the manufacturers of the monitors used in the provision of services by PDSHeart must also comply with FDA and foreign regulatory requirements, which often require significant resources and subject us and our suppliers to potential regulatory inspections and stoppages. We or our suppliers may not satisfy these requirements. If we or our suppliers do not maintain regulatory approval for our manufacturing operations, our business would be harmed.
Our dependence on a limited number of suppliers may prevent us from delivering our devices on a timely basis.
We currently rely on a limited number of suppliers of components for the CardioNet System. If these suppliers became unable to provide components in the volumes needed or at an acceptable price, we would have to identify and qualify acceptable replacements from alternative sources of supply. Qualifying suppliers is a lengthy process. Delays or interruptions in the supply of our requirements could limit or stop our ability to provide sufficient quantities of devices on a timely basis, meet demand for our services, which could have a material adverse effect on our business, financial condition and results of operations.
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We could be subject to medical liability or product liability claims which may not be covered by insurance and which would adversely affect our business and results of operations.
The design, manufacture and marketing of services of the types we provide entail an inherent risk of product liability claims. Any such claims against us may require us to incur significant defense costs, irrespective of whether such claims are founded. In addition, we provide information to health care providers and payors upon which determinations affecting medical care are made, and claims may be made against us resulting from adverse medical consequences to patients resulting from the information we provide. In addition, we may become subject to liability in the event that the monitors and sensors we use fail to correctly record or transfer patient information or if we provide incorrect information to patients or health care providers using our services. We have also agreed to indemnify QUALCOMM for any claims resulting from the provision of our services. If we incur one or more significant claims against us, if we are required to indemnify QUALCOMM as a result of the provision of our services, or if we are required to undertake remedial actions in response to any such claims, such claims or actions would adversely affect our business and results of operations.
Our liability insurance is subject to deductibles and coverage limitations. In addition, our current insurance may not continue to be available to us on acceptable terms, if at all, and, if available, the coverages may not be adequate to protect us against any future claims. If we are unable to obtain insurance at an acceptable cost or on acceptable terms with adequate coverage or otherwise protect against any claims against us, we will be exposed to significant liabilities, which may harm our business.
If we do not obtain and maintain adequate protection for our intellectual property, the value of our technology and devices may be adversely affected.
Our business and competitive positions are dependent in part upon our ability to protect our proprietary technology. To protect our proprietary rights, we rely on a combination of trademark, copyright, patent, trade secret and other intellectual property laws, employment, confidentiality and invention assignment agreements with our employees and contractors, and confidentiality agreements and protective contractual provisions with our partners and other third parties. We attempt to protect our intellectual property position by filing trademark applications and U.S., foreign and international patent applications related to our proprietary technology, inventions and improvements that are important to the development of our business.
As of June 30, 2007, we had 14 issued U.S. patents, seven foreign patents and 42 pending U.S., foreign and international patent applications relating to various aspects of the CardioNet System. As of June 30, 2007, we also had eight trademark registrations and four pending trademark applications in the United States for a variety of word marks and slogans. We do not believe that any single patent, trademark or other intellectual property right of ours, or combination of our intellectual property rights, is likely to prevent others from competing with us using a similar business model. There are many issued patents and patent applications held by others in our industry and the electronics field. Our competitors may independently develop technologies that are substantially similar or superior to our technologies, or design around our patents or other intellectual property to avoid infringement. In addition, we may not apply for a patent relating to products or processes that are patentable, we may fail to receive any patent for which we apply or have applied, and any patent owned by us or issued to us could be circumvented, challenged, invalidated, or held to be unenforceable, or rights granted thereunder may not adequately protect our technology or provide a competitive advantage to us. For example, with respect to one of our U.S. patents, we have a corresponding foreign patent, the claims of which were amended substantially more so than in the U.S., to overcome art that was of record in the U.S. patent. If a third-party challenges the validity of any patents or proprietary rights of ours, we may become involved in intellectual property disputes and litigation that would be costly and time-consuming.
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Although third parties may infringe our patents and other intellectual property rights, we may not be aware of any such infringement, or we may be aware of potential infringement but elect not to seek to prevent such infringement or pursue any claim of infringement, and the third party may continue its potentially infringing activities. Any decision whether or not to take action in response to potential infringement of our patent or other intellectual property rights may be based on any one or more of a variety of factors, such as the potential costs and benefits of taking such action, and business and legal issues and circumstances. Litigation of claims of infringement of a patent or other intellectual property rights may be costly and time-consuming and divert the attention of key company personnel, and may not be successful or result in any significant recovery of compensation for any infringement or enjoining of any infringing activity. Litigation or licensing discussions may also involve or lead to counterclaims or proceedings that could be brought by a potential infringer to challenge the validity or enforceability of our patents and other intellectual property.
To protect our trade secrets and other proprietary information, we generally require our employees, consultants, contractors and outside collaborators to enter into written nondisclosure agreements. These agreements, however, may not provide adequate protection to prevent any unauthorized use, misappropriation or disclosure of our trade secrets, know-how or other proprietary information. These agreements may be breached, and we may not become aware of, or have adequate remedies in the event of, any such breach. Also, others may independently develop the same or substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets.
Our ability to market our services may be impaired by the intellectual property rights of third parties.
Our success is dependent in part upon our ability to avoid infringing the patents or proprietary rights of others. Our industry and the electronics field are characterized by a large number of patents, patent filings and frequent litigation based on allegations of patent infringement. Competitors may have filed applications for or have been issued patents and may obtain additional patents and proprietary rights related to devices, services or processes that we compete with or are similar to ours. We may not be aware of all of the patents or patent applications potentially adverse to our interests that may have been or may later be issued to or filed by others. U.S. patent applications may be kept confidential while pending in the Patent and Trademark Office. If other companies have or obtain patents relating to our products or services, we may be required to obtain licenses to those patents or to develop or obtain alternative technology. We may not be able to obtain any such licenses on acceptable terms, or at all. Any failure to obtain such licenses could impair or foreclose our ability to make, use, market or sell our products and services.
Based on the litigious nature of our industry and the electronics field and the fact that we may pose a competitive threat to some companies who own or control various patents, it is always possible that one or more third parties may assert a patent infringement claim seeking damages and to enjoin the manufacture, use, sale and marketing of our products and services. If a third-party asserts that we have infringed its patent or proprietary rights, we may become involved in intellectual property disputes and litigation that would be costly and time-consuming and could impair or foreclose our ability to make, use, market or sell our products and services. For example, a competitor initiated a patent infringement lawsuit against us in November 2004, which we defended and ultimately settled in March 2006. Other lawsuits may have already been filed against us without our knowledge, or may be filed prior to the completion of this offering. Additionally, we have received and expect to continue to receive notices from third parties suggesting that we are infringing their patents and inviting us to license such patents. We do not believe, however, that we are infringing any such patent or that a license to any such patent is necessary. Should litigation over such patents arise, which could occur if, for example, a third party files a lawsuit alleging infringement of such patents or if we file a lawsuit challenging such patents as being invalid or unenforceable, we intend to vigorously defend against any
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allegation of infringement. If we are found to infringe the patent or intellectual property rights of others, we may be required to pay damages, stop the infringing activity or obtain licenses or rights to the patents or other intellectual property in order to use, manufacture, market or sell our products and services. Any required license may not be available to us on acceptable terms or at all. If we succeed in obtaining such licenses, payments under such licenses would reduce any earnings from our products. In addition, licenses may be non-exclusive and, accordingly, our competitors may have access to the same technology as that which may be licensed to us. If we fail to obtain a required license or are unable to alter the design of our product candidates to make a license unnecessary, we may be unable to manufacture, use, market or sell our products and services, which could significantly affect our ability to achieve, sustain or grow our commercial business. Moreover, regardless of the outcome, patent litigation against or by us could significantly disrupt our business, divert our management's attention and consume our financial resources. We cannot predict if or when any third party will file suit for patent or other intellectual property infringement.
We are highly dependent on our Chief Executive Officer and other key employees, and if we are not able to retain them or to recruit and retain additional qualified personnel, our business may suffer.
We are highly dependent upon our Chief Executive Officer and other key employees. The loss of their services could have a material adverse effect on our business, financial condition and results of operations. In particular, our Chief Executive Officer, James M. Sweeney, is critical to the operations and function of the company. In addition, in the event we desire to appoint a replacement to Mr. Sweeney following his resignation or termination, such replacement must be approved by Silicon Valley Bank. The employment of our executive officers and key employees with us is "at will," and each employee can terminate his or her relationship with us at any time. We do not carry "key person" life insurance on any of our employees other than James M. Sweeney, our Chief Executive Officer.
We will need to hire additional senior executives and qualified scientific, commercial, regulatory, sales, quality assurance and control and administrative personnel as we continue to expand our commercial activities. We may not be able to attract and retain qualified personnel on acceptable terms given the competition for such personnel among companies that provide arrhythmia monitoring solutions. We have offices in Pennsylvania, California, Florida, Georgia and Minnesota. Competition for personnel with arrhythmia monitoring experience in each of those areas is intense. If we fail to identify, attract, retain and motivate these highly skilled personnel, or if we lose current employees, we may be unable to continue our business operations.
If we fail to obtain and maintain necessary FDA clearances, our business would be harmed.
The monitors and sensors that we manufacture and sell as part of the CardioNet System are classified as medical devices and are subject to extensive regulation by the FDA. Further, we maintain establishment registration with the FDA as a distributor of medical devices. FDA regulations govern manufacturing, labeling, promotion, distribution, importing, exporting, shipping and sale of these devices.
The CardioNet System, including our C3 System, and our arrhythmia detection algorithms maintain FDA 510(k) clearance from the FDA. Modifications to the CardioNet System or our algorithms that could significantly affect safety or effectiveness, or that could constitute a significant change in intended use, would require a new clearance from the FDA. If in the future we make changes to the CardioNet System or our algorithms, the FDA could determine that such modifications require new FDA clearance, and we may not be able to obtain such FDA clearances in a timely fashion or at all.
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We are subject to continuing regulation by the FDA, including quality regulations applicable to the manufacture of the CardioNet System and various reporting regulations and regulations that govern the promotion and advertising of medical devices. The FDA could find that we have failed to comply with one of these requirements, which could result in a wide variety of enforcement actions, ranging from a warning letter to one or more severe sanctions, including the following:
Any of these enforcement actions could be costly and significantly harm our business, financial condition and results of operations.
Enforcement of federal and state laws regarding privacy and security of patient information may adversely affect our business, financial condition or operations.
The use and disclosure of certain health care information by health care providers and their business associates have come under increasing public scrutiny. Recent federal standards under the Health Insurance Portability and Accountability Act of 1996, or HIPAA, establish rules concerning how individually-identifiable health information may be used, disclosed and protected. Historically, state law has governed confidentiality issues, and HIPAA preserves these laws to the extent they are more protective of a patient's privacy or provide the patient with more access to his or her health information. As a result of the implementation of the HIPAA regulations, many states are considering revisions to their existing laws and regulations that may or may not be more stringent or burdensome than the federal HIPAA provisions. We must operate our business in a manner that complies with all applicable laws, both federal and state, and that does not jeopardize the ability of our customers to comply with all applicable laws. We believe that our operations are consistent with these legal standards. Nevertheless, these laws and regulations present risks for health care providers and their business associates that provide services to patients in multiple states. Because these laws and regulations are recent, and few have been interpreted by government regulators or courts, our interpretations of these laws and regulations may be incorrect. If a challenge to our activities is successful, it could have an adverse effect on our operations, may require us to forego relationships with customers in certain states and may restrict the territory available to us to expand our business. In addition, even if our interpretations of HIPAA and other federal and state laws and regulations are correct, we could be held liable for unauthorized uses or disclosures of patient information as a result of inadequate systems and controls to protect this information or as a result of the theft of information by unauthorized computer programmers who penetrate our network security. Enforcement of these laws against us could have a material adverse effect on our business, financial condition and results of operations.
We may be subject, directly or indirectly, to federal and state health care fraud and abuse laws and regulations and, if we are unable to fully comply with such laws, could face substantial penalties.
Our operations may be directly or indirectly affected by various broad state and federal health care fraud and abuse laws, including the Federal Healthcare Programs' Anti-Kickback Statute, which prohibits any person from knowingly and willfully offering, paying, soliciting or receiving remuneration,
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directly or indirectly, to induce or reward either the referral of an individual for an item or service, or the ordering, furnishing or arranging for an item or service, for which payment may be made under federal health care programs, such as the Medicare and Medicaid programs. For some of our services, we directly bill physicians for our services, who in turn bill payors. Although we believe such payments to be proper and in compliance with laws and regulations, we may be subject to claims that we are in violation of these laws and regulations. If our past or present operations are found to be in violation of these laws, we or our officers may be subject to civil or criminal penalties, including large monetary penalties, damages, fines, imprisonment and exclusion from Medicare and Medicaid program participation. If enforcement action were to occur, our business and results of operations could be adversely affected.
The operation of our call centers and monitoring facilities is subject to rules and regulations governing Independent Diagnostic Testing Facilities; failure to comply with these rules could prevent us from receiving reimbursement from Medicare and some commercial payors.
We have call centers and monitoring facilities in Pennsylvania, Georgia, Florida, and Minnesota that analyze the data obtained from arrhythmia monitors and report the results to physicians. In order for us to receive reimbursement from Medicare and some commercial payors, we must have a call center certified as an Independent Diagnostic Testing Facility, or IDTF. Certification as an IDTF requires that we follow strict regulations governing how the center operates, such as requirements regarding the experience and certifications of the technicians who review data transmitted from our monitors. These rules and regulations vary from location to location and are subject to change. If they change, we may have to change the operating procedures at our monitoring facilities and call centers, which could increase our costs significantly. If we fail to obtain and maintain IDTF certification, our services may no longer be reimbursed by Medicare and some commercial payors, which could have a material adverse impact on our business.
We may be subject to federal and state false claims laws which impose substantial penalties.
Many of the physicians and patients who use our services file claims for reimbursement with government programs such as Medicare and Medicaid. As a result, we may be subject to the federal False Claims Act if we knowingly "cause" the filing of false claims. Violations may result in substantial civil penalties, including treble damages. The federal False Claims Act also contains "whistleblower" or "qui tam" provisions that allow private individuals to bring actions on behalf of the government alleging that the defendant has defrauded the government. In recent years, the number of suits brought in the medical industry by private individuals has increased dramatically. Various states have enacted laws modeled after the federal False Claims Act, including "qui tam" provisions, and some of these laws apply to claims filed with commercial insurers.
We are unable to predict whether we could be subject to actions under the federal False Claims Act, or the impact of such actions. However, the costs of defending claims under the False Claims Act, as well as sanctions imposed under the False Claims Act, could significantly affect our financial performance.
Changes in the regulatory environment may constrain or require us to restructure our operations, which may harm our revenues and operating results.
Health care laws and regulations change frequently and may change significantly in the future. We may not be able to adapt our operations to address every new regulation, and new regulations may adversely affect our business. We cannot assure you that a review of our business by courts or regulatory authorities would not result in a determination that adversely affects our revenues and operating results, or that the health care regulatory environment will not change in a way that restricts our operations. In addition, as a result of the focus on health care reform in connection with the 2008
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presidential election, there is risk that Congress may implement changes in laws and regulations governing health care service providers, including measures to control costs, or reductions in reimbursement levels, which may adversely affect our business and results of operations.
Changes in the health care industry or tort reform could reduce the number of arrhythmia monitoring solutions ordered by physicians, which could result in a decline in the demand for our solutions, pricing pressure and decreased revenues.
Changes in the health care industry directed at controlling health care costs or perceived over-utilization of arrhythmia monitoring solutions could reduce the volume of solutions ordered by physicians. If more health care cost controls are broadly instituted throughout the health care industry, the volume of cardiac monitoring solutions could decrease, resulting in pricing pressure and declining demand for our services, which could harm our operating results. In addition, it has been suggested that some physicians order arrhythmia monitoring solutions even when the services may have limited clinical utility in large part to establish a record for defense in the event of a claim of medical malpractice against the physician. Legal changes making it more difficult to bring medical malpractice cases, known as tort reform, could reduce the amount of our services prescribed as physicians respond to reduced risks of litigation, which could harm our operating results.
Risks related to the securities market and investment in our common stock
There may not be a viable public market for our common stock.
Prior to this offering, there has been no public market for our common stock. The initial public offering price for our common stock will be determined through negotiations between us and the representatives of the underwriters and may not be indicative of the market price of our common stock following this offering. If you purchase shares of our common stock, you may not be able to resell those shares at or above the initial public offering price. We cannot predict the extent to which investor interest in our company will lead to the development of an active trading market on the Nasdaq Global Market or any other stock market or how liquid any such market might become. An active public market for our common stock may not develop or be sustained after the offering. If an active public market does not develop or is not sustained, it may be difficult for you to sell your shares of common stock at a price that is attractive to you, or at all.
Our quarterly operating results and stock price may be volatile or may decline regardless of our operating performance, and you may not be able to resell your shares at or above the initial public offering price.
Following this offering, the market price for our common stock is likely to be volatile, in part because our shares have not been traded publicly. In addition, the market price of our common stock may fluctuate significantly in response to a number of factors, most of which we cannot control, including:
23
In addition, the stock markets, and in particular the Nasdaq Global Market, have experienced extreme price and volume fluctuations that have affected and continue to affect the market prices of equity securities of many health care companies. Stock prices of many health care companies have fluctuated in a manner unrelated or disproportionate to the operating performance of those companies. In the past, stockholders have instituted securities class action litigation following periods of market volatility. If we were involved in securities litigation, we could incur substantial costs, and our resources and the attention of management could be diverted from our business.
Future sales of our common stock or securities convertible into our common stock may depress our stock price.
Sales of a substantial number of shares of our common stock or securities convertible into our common stock in the public market could occur at any time. These sales, or the perception in the market that the holders of a large number of shares intend to sell shares, could reduce the market price of our common stock. After this offering, we will have outstanding shares of common stock based on the number of shares outstanding as of June 30, 2007, assuming an initial public offering price of $ per share, the mid-point of the price range set forth on the cover page of this prospectus. This includes the shares that we are selling in this offering, which may be resold in the public market immediately unless held by an affiliate of ours. Of the remaining shares, shares may be sold upon the expiration of lock-up agreements at least 180 days after the date of this offering and the remaining shares may be sold from time to time after the expiration of such lock-up agreements and applicable holding periods specified in Rule 144 under the Securities Act of 1933, as amended, or the Securities Act, as more fully described in the "Shares Eligible for Future Sale" section of this prospectus. In addition, following the offering, we will have outstanding warrants to purchase up to 12,500 shares of our common stock that, if exercised, would result in these additional shares becoming available for sale upon expiration of the lock-up agreements.
24
In July 2007, the SEC announced proposed revisions to Rule 144. If the proposed changes to Rule 144 are approved, the holding period for restricted shares of our common stock after the completion of this offering may be reduced to six months under specified circumstances, the restrictions on the sale of restricted shares of our common stock held by our affiliates may be reduced and certain other restrictions on resale of the shares of our common stock under Rule 144 may be modified to make it easier for our stockholders under specified circumstances to sell their shares upon the expiration of the lock-up agreements beginning 180 days after the date of this prospectus. We do not know whether these proposed revisions to Rule 144 will be adopted as proposed or in a modified form, or at all.
After this offering, based on the number of shares outstanding as of June 30, 2007, assuming an initial public offering price of $ per share, the mid-point of the price range set forth on the cover page of this prospectus, holders of up to approximately shares of common stock (including shares of our common stock issuable upon the exercise of warrants) will have rights, subject to some conditions, to require us to file registration statements covering their shares or to include their shares in registration statements that we may file for ourselves or other stockholders. These rights will terminate years following the completion of this offering, or for any particular holder with registration rights who holds less than one percent of our outstanding capital stock, at any time following this offering when all securities held by that stockholder that are subject to registration rights may be sold pursuant to Rule 144 under the Securities Act within a single 90 day period. We also intend to register all shares of common stock that we may issue after this offering under our equity compensation plans. Once we register these shares, they can be freely sold in the public market upon issuance, subject to the lock-up agreements described above.
We agreed to register the shares of our common stock that will be issued at the closing of this offering upon conversion of our mandatorily redeemable convertible preferred stock within 90 days of the completion of this offering, and use commercially reasonable best efforts to cause the registration statement to become effective within 180 days after the completion of this offering. Once registered, these shares will be freely tradable. If we fail to register these shares when and as required, we will be required to pay liquidated damages at a rate of 0.5% of the original purchase price of the mandatorily redeemable convertible preferred stock, plus accrued and unpaid dividends, for the initial failure and 1.0% of the original purchase price of the mandatorily redeemable convertible preferred stock, plus accrued and unpaid dividends, for each 30-day period thereafter that the failure goes uncured.
If a large number of our shares of our common stock or securities convertible into our common stock are sold in the public market after they become eligible for sale, the sales could reduce the trading price of our common stock and impede our ability to raise future capital.
Anti-takeover provisions in our charter documents and Delaware law might deter acquisition bids for us that you might consider favorable.
Upon completion of this offering, our amended and restated certificate of incorporation and bylaws will contain provisions that may make the acquisition of our company more difficult without the approval of our board of directors. These provisions will:
25
In addition, upon our reincorporation, we are governed by the provisions of Section 203 of the Delaware General Corporation Law which, subject to certain exceptions, prohibits stockholders owning in excess of 15% of our outstanding voting stock from merging or combining with us. These anti-takeover provisions and other provisions under Delaware law could discourage, delay or prevent a transaction involving a change of control of our company, even if doing so would benefit our stockholders. These provisions could also discourage proxy contests and make it more difficult for you and other stockholders to elect directors of your choosing and cause us to take other corporate actions you desire.
If you purchase shares of common stock sold in this offering, you will incur immediate and substantial dilution.
If you purchase shares of common stock in this offering, you will incur immediate and substantial dilution in the amount of $ per share, assuming an initial public offering price of $ per share, the mid-point of the price range set forth on the cover page of this prospectus, to the extent that the initial public offering price is substantially higher than the pro forma net book value per share of our outstanding common stock would be after this offering. This dilution is due in large part to the fact that, when they purchased their shares, our earlier investors paid substantially less than the initial public offering price. In addition, you may also experience additional dilution upon future equity issuances or the exercise of stock options to purchase common stock granted to our employees, consultants and directors under our stock option and equity incentive plans. See the "Dilution" section of this prospectus.
Our existing principal stockholders, executive officers and directors will continue to have substantial control over us after this offering, which may prevent you and other stockholders from influencing significant corporate decisions and may harm the market price of our common stock.
Upon completion of this offering, assuming no exercise of the underwriters' over-allotment option and including stock options that are exercisable within 60 days of June 30, 2007, our existing principal stockholders, executive officers and directors, together with their affiliates, will beneficially own, in the aggregate, approximately % of our outstanding common stock. These stockholders may have interests that conflict with yours and, if acting together, have the ability to determine the outcome of matters submitted to our stockholders for approval, including the election and removal of directors and any merger, consolidation or sale of all or substantially all of our assets. In addition, these stockholders, acting together, may have the ability to control our management and affairs. Accordingly, this concentration of ownership may harm the market price of our common stock by:
26
If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
The trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish about us or our business. We do not currently have and may never obtain research coverage by securities and industry analysts. If no securities or industry analysts commence coverage of our company, the trading price for our stock would be negatively impacted. If we obtain securities or industry analyst coverage and if one or more of the analysts who covers us downgrades our stock or publishes inaccurate or unfavorable research about our business, our stock price would likely decline. If one or more of these analysts ceases coverage of us or fails to publish reports on us regularly, demand for our stock could decrease, which could cause our stock price and trading volume to decline.
Because management has broad discretion as to the use of the net proceeds from this offering, you may not agree with how we use them, and such proceeds may not be applied successfully.
Our management will have considerable discretion over the use of proceeds from this offering. We intend to use the net proceeds from this offering:
We have no present understandings, commitments or agreements with respect to the acquisition or license of any products, technologies or businesses.
A significant portion of the net proceeds from this offering have not been allocated for any specific transaction. As a result, our management will have broad discretion in the application of certain of the net proceeds from this offering and could spend such proceeds in ways that do not necessarily improve our operating results or enhance the value of our common stock. You will be relying on the judgment of our management concerning these uses, and you will not have the opportunity, as part of your investment decision, to assess whether the proceeds are being used appropriately. The failure of our management to apply these funds effectively could result in unfavorable returns and uncertainty about our prospects, each of which could cause the price of our common stock to decline.
We do not expect to pay any cash dividends for the foreseeable future.
The continued expansion of our business may require substantial funding. In addition, the terms of our loan and security agreements with Silicon Valley Bank prohibit us from paying cash dividends under certain circumstances. Accordingly, we do not anticipate that we will pay any cash dividends on shares of our common stock for the foreseeable future. Even if we are not prohibited from paying dividends, any determination to do so in the future will be at the discretion of our board of directors and will depend upon our results of operations, financial condition, contractual restrictions, restrictions imposed by applicable law and other factors our board of directors deems relevant. Accordingly, if you purchase shares in this offering, realization of a gain on your investment will depend on the appreciation of the price of our common stock, which may never occur. Investors seeking cash dividends in the foreseeable future should not purchase our common stock.
27
This prospectus contains forward-looking statements that are based on our management's beliefs and assumptions and on information currently available to our management. The forward-looking statements are contained principally in "Prospectus Summary," "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations," and "Business." Forward-looking statements include all statements that are not historical facts and can sometimes be identified by terms such as "anticipates," "believes," "could," "seeks," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" or similar expressions and the negatives of those statements.
Forward-looking statements include, but are not limited to, statements about:
Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. We discuss these risks in greater detail in "Risk Factors." Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our management's beliefs and assumptions only as of the date of this prospectus. You should read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect.
Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. The forward-looking statements contained in this prospectus are excluded from the safe harbor protections provided by the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended.
28
We estimate that the net proceeds to us from this offering will be approximately $ million, based upon an assumed initial public offering price of $ per share, the mid-point of the price range set forth on the cover page of this prospectus, and after deducting estimated underwriting discounts and commissions and estimated offering expenses. We will not receive any of the proceeds from the sale of common stock by the selling stockholders. If the underwriters exercise their over-allotment option in full, then the net proceeds to us will be approximately $ million.
A $1.00 increase (decrease) in the assumed initial public offering price of $ per share, the mid-point of the price range set forth on the cover page of this prospectus, would increase (decrease) the net proceeds to us from this offering by approximately $ million, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting underwriter discounts and commissions and estimated offering expenses payable by us. If the underwriters fully exercise their over-allotment option, we estimate that the net proceeds to us from this offering will be approximately $ million.
The principal purposes of this offering are to obtain additional capital to support our operations, to create a public market for our common stock and to facilitate our future access to the public equity markets.
We intend to use the net proceeds to us from this offering as follows:
We anticipate using the remaining net proceeds to us from this offering for working capital and general corporate purposes. Accordingly, our management will have broad discretion in the application of the net proceeds of this offering to us, and investors will be relying on the judgment of our management regarding the application of these proceeds.
Pending their use, we plan to invest the net proceeds to us from this offering in short- and intermediate-term, interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the U.S. government.
We believe that the net proceeds to us from this offering, together with interest thereon, our existing cash, cash equivalents and short-term investments, will be sufficient to fund our operations for the forseeable future.
29
We have never declared or paid any cash dividends on our capital stock. We currently intend to retain all available funds and any future earnings to support our operations and finance the growth and development of our business. We do not intend to pay cash dividends on our common stock for the foreseeable future. Any future determination related to dividend policy will be made at the discretion of our board of directors. In addition, unless waived, the terms of our loan and security agreement with Silicon Valley Bank prohibit us from paying dividends on our common stock.
30
The following table sets forth our cash, cash equivalents and capitalization as of June 30, 2007:
(1) the filing of an amended and restated certificate of incorporation to authorize 200,000,000 shares of common stock and 10,000,000 shares of undesignated preferred stock;
(2) the sale of shares of common stock by us in this offering at an assumed initial offering price of $ per share, the mid-point of the price range set forth on the cover page of this prospectus after deducting estimated underwriting discounts and commissions and estimated offering expenses;
(3) the conversion of all our outstanding shares of preferred stock into shares of common stock upon the completion of this offering, assuming an initial public offering price of $ per share, the mid-point of the price range set forth on the cover page of this prospectus;
(4) the automatic cashless exercise of warrants upon the completion of this offering, resulting in the issuance of shares of our common stock, assuming an initial public offering price of $ per share, the mid-point of the price range set forth on the cover page of this prospectus; and
(5) the repayment of the term loan from Guidant Investment Corporation that occurred on August 15, 2007.
You should read the information in this table together with our consolidated financial statements and accompanying notes and "Management's Discussion and Analysis of Financial Condition and Results of Operations" appearing elsewhere in this prospectus.
|
|
As of June 30, 2007
|
|||||
|---|---|---|---|---|---|---|
|
|
Actual
|
As Adjusted(1)
|
||||
|
|
(unaudited)
|
|||||
|
|
(in thousands, except share and per share data)
|
|||||
| Cash and cash equivalents | $ | 50,334 | ||||
|
|
|
|||||
| Debt obligations: | ||||||
| Note payable to shareholder | 23,301 | | ||||
| Long term debt, including current portion | 3,243 | |||||
| Redeemable Preferred Stock: | ||||||
| Series A, B, C, D and D-1 convertible preferred stock: 18,000,000 shares authorized; 17,670,106 shares issued and outstanding, actual shares authorized, no shares issued or outstanding, as adjusted | 53,456 | | ||||
| Mandatorily redeemable convertible preferred stock: 114,883 shares authorized; 114,839 issued and outstanding, actual; no shares authorized, issued and outstanding, as adjusted | 109,803 | |||||
|
|
|
|||||
| Shareholders' equity: | ||||||
| Common stock, $0.001 par value: 36,000,000 shares authorized; 6,392,203 shares issued and outstanding, actual; shares authorized, no shares issued or outstanding, as adjusted | 1,567 | |||||
| Additional paid-in capital | | |||||
| Deferred compensation | (501 | ) | ||||
| Accumulated deficit | (80,946 | ) | ||||
|
|
|
|||||
| Total stockholders' equity (deficit) | (79,880 | ) | ||||
|
|
|
|||||
| Total capitalization | $ | 109,923 | ||||
|
|
|
|||||
31
The number of shares of common stock outstanding as of June 30, 2007 excludes:
The number of shares of our common stock issuable upon conversion of each share of our mandatorily redeemable convertible preferred stock and the number of shares of common stock issuable upon the cashless exercise of outstanding warrants to purchase shares of our Series D-1 preferred stock each varies according to a formula that depends on the initial public offering price. As a result, the total number of shares of our common stock that will be outstanding following this offering depends on the initial public offering price. The following table shows how the number of shares varies over a range of initial public offering prices:
|
|
Initial public offering price
|
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|---|---|---|---|---|---|---|---|---|---|---|---|---|
| $ | $ | $ | $ | |||||||||
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|
|
|||||||||
| Number of shares of common stock outstanding, actual | ||||||||||||
| Number of shares of common stock issued upon conversion of preferred stock other than mandatorily redeemable convertible preferred stock | ||||||||||||
| Number of shares of common stock issued upon conversion of mandatorily redeemable convertible preferred stock | ||||||||||||
| Number of shares of common stock issued upon automatic cashless exercise of warrants | ||||||||||||
| Number of shares of our common stock issued in the offering | ||||||||||||
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|||||||||
| Total number of shares of common stock outstanding following the offering, as adjusted | ||||||||||||
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|
|
|
|
|||||||||
For more information on the conversion provisions of our mandatorily redeemable convertible preferred stock and exercise provisions of warrants to purchase our Series D-1 preferred stock, see "Description of Capital Stock."
32
If you invest in our common stock in this offering, your ownership interest will be diluted to the extent of the difference between the initial public offering price per share and the pro forma net tangible book value per share of our common stock after this offering. The historical net tangible book value of our common stock as of June 30, 2007 was approximately $39.4 million, or approximately $6.34 per share, based on the number of shares of common stock outstanding as of June 30, 2007. Historical net tangible book value per share is determined by dividing the number of shares of common stock outstanding as of June 30, 2007 into our total tangible assets (total assets less intangible assets less total liabilities). After giving effect to the conversion of all outstanding shares of preferred stock into shares of common stock and the automatic cashless exercise of warrants for shares of common stock, assuming an initial public offering price of $ per share, the mid-point of the price range set forth on the cover page of this prospectus, in this offering, our pro forma net tangible book value per share as of June 30, 2007 would have been approximately $ million, or approximately $ per share.
Investors participating in this offering will incur immediate, substantial dilution. After giving effect to the sale of common stock offered by us in this offering at an assumed initial public offering price of $ per share, the mid-point of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us, our pro forma as adjusted net tangible book value as of June 30, 2007 would have been approximately $ million, or approximately $ per share of common stock. This represents an immediate increase of $ per share to existing stockholders, and an immediate dilution of $ per share to investors participating in this offering. The following table illustrates this per share dilution:
| Assumed initial public offering price per share | $ | |||||
| Historical net tangible book value per share as of June 30, 2007 | $ | |||||
| Pro forma decrease in net tangible book value per share attributable to conversion of preferred stock and automatic exercise of warrants | ( | ) | ||||
| Pro forma net tangible book value per share as of June 30, 2007 | $ | |||||
| Increase in net tangible book value per share attributable to investors participating in this offering | ||||||
|
|
||||||
| Pro forma as adjusted net tangible book value per share after this offering | ||||||
|
|
||||||
| Dilution per share to investors participating in this offering | $ | |||||
|
|
||||||
A $1.00 increase (decrease) in the assumed initial public offering price of $ per share, the mid-point of the price range set forth on the cover page of this prospectus, would increase (decrease) our pro forma net tangible book value as of June 30, 2007 by approximately $ million, the pro forma as adjusted net tangible book value per share after this offering by $ and the dilution in pro forma as adjusted net tangible book value to new investors in this offering by $ per share, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.
If the underwriters exercise their over-allotment option in full to purchase additional shares of common stock in this offering, the pro forma as adjusted net tangible book value per share after the offering would be $ per share, the increase in the pro forma net tangible book value per share to existing stockholders would be $ per share and the dilution to new investors purchasing common stock in this offering would be $ per share.
33
The following table summarizes, on a pro forma as adjusted basis as of June 30, 2007, the differences between the number of shares of common stock purchased from us, the total consideration and the average price per share paid to us by existing stockholders and by investors participating in this offering, before deducting estimated underwriting discounts and commissions and estimated offering expenses, at an assumed initial public offering price of $ per share, the mid-point of the price range set forth on the cover page of this prospectus:
|
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Shares purchased
|
Total consideration
|
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Average price
per share |
||||||||||||
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Number
|
Percent
|
Amount
|
Percent
|
|||||||||
| Existing stockholders before this offering | % | $ | % | $ | |||||||||
| Investors participating in this offering | |||||||||||||
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|||||||||
| Total | % | $ | % | $ | |||||||||
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|
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|
|||||||||
A $1.00 increase (decrease) in the assumed initial public offering price of $ per share, the mid-point of the price range set forth on the cover page of this prospectus, would increase (decrease) total consideration paid to us by investors participating in this offering by approximately $ million, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.
The discussion and tables above assume no exercise of the underwriters' over-allotment option or any outstanding options or warrants (except for the automatic cashless exercise of warrants to purchase shares of our Series D-1 preferred stock upon the completion of this offering) and no sale of common stock by the selling stockholders. The sale of shares of common stock to be sold by the selling stockholders in this offering will reduce the number of shares held by existing stockholders to , or % of the total shares outstanding, and will increase the number of shares held by investors participating in this offering to or % of the total shares outstanding. In addition, if the underwriters' over-allotment option is exercised in full, the number of shares of common stock held by existing stockholders will be further reduced to , or % of the total number of shares of common stock to be outstanding after this offering, and the number of shares of common stock held by investors participating in this offering will be further increased to , or % of the total number of shares of common stock to be outstanding after this offering.
The number of shares outstanding as of June 30, 2007 excludes:
To the extent that any options or warrants are exercised, new options or shares of common stock are issued under our 2003 Equity Incentive Plan, 2007 Equity Incentive Plan, 2007 Non-Employee Directors' Stock Option Plan or our 2007 Employee Stock Purchase Plan or we issue additional shares of common stock in the future, there will be further dilution to investors participating in this offering.
34
UNAUDITED PRO FORMA CONSOLIDATED STATEMENTS OF OPERATIONS
The following unaudited pro forma consolidated statements of operations for the year ended December 31, 2006 and the six months ended June 30, 2007 are based on the historical statements of operations of CardioNet, Inc. and PDSHeart, Inc. giving effect to our acquisition of PDSHeart as if the acquisition had occurred on January 1, 2006, in the case of the year ended December 31, 2006, and as if the acquisition had occurred on January 1, 2007, in the case of the six months ended June 30, 2007.
The unaudited pro forma consolidated statements of operations are based on estimates and assumptions which are preliminary and subject to change, as set forth in the related notes to such statements. The unaudited pro forma consolidated financial statements are presented for illustrative purposes only and are not necessarily indicative of the combined results of operations to be expected in any future period or the results that actually would have been realized had the entities been a single entity during these periods. This information should be read in conjunction with the historical financial statements and related notes of CardioNet and PDSHeart included in this prospectus, and in conjunction with the accompanying notes to these unaudited pro forma consolidated statements of operations.
35
CardioNet, Inc.
Unaudited Pro Forma Consolidated Statement of Operations
Year ended December 31, 2006
(in thousands)
|
|
CardioNet
|
PDSHeart
|
Notes
|
Pro Forma
Adjustments |
Pro Forma
Consolidated |
|||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
|
(unaudited)
|
||||||||||||
| Revenues | ||||||||||||||||
| Net patient revenues | $ | 33,019 | $ | 20,681 | $ | | $ | 53,700 | ||||||||
| Other revenues | 904 | 171 | | 1,075 | ||||||||||||
|
|
|
|
|
|||||||||||||
| Total revenues | 33,923 | 20,852 | | 54,775 | ||||||||||||
| Cost of revenues | (12,701 | ) | (7,493 | ) | | (20,194 | ) | |||||||||
|
|
|
|
|
|||||||||||||
| Gross profit | 21,222 | 13,359 | 34,581 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | (3,631 | ) | | | (3,631 | ) | ||||||||||
| General and administrative | (15,631 | ) | (6,760 | ) | (a | ) | (327 | ) | (22,064 | ) | ||||||
| Sales and marketing | (6,448 | ) | (4,969 | ) | (b | ) | 113 | (11,304 | ) | |||||||
| Amortization | | (183 | ) | (c | ) | (802 | ) | (985 | ) | |||||||
|
|
|
|
|
|||||||||||||
| Total expenses | (25,710 | ) | (11,912 | ) | (362 | ) | (37,984 | ) | ||||||||
|
|
|
|
|
|||||||||||||
| Income (loss) from operations | (4,488 | ) | 1,447 | (362 | ) | (3,403 | ) | |||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 114 | 40 | (d | ) | (22 | ) | 132 | |||||||||
| Interest expense | (2,341 | ) | (817 | ) | (e | ) | 445 | (2,713 | ) | |||||||
|
|
|
|
|
|||||||||||||
| Total other income (expense) | (2,226 | ) | (777 | ) | 423 | (2,581 | ) | |||||||||
| Income tax (expense) benefit | | (3 | ) | (f | ) | 3 | | |||||||||
|
|
|
|
|
|||||||||||||
| Net income (loss) | $ | (6,714 | ) | $ | 667 | $ | 64 | $ | (5,984 | ) | ||||||
|
|
|
|
|
|||||||||||||
36
CardioNet, Inc.
Unaudited Pro Forma Consolidated Statement of Operations
Six Months ended June 30, 2007
(in thousands)
|
|
Six Months
Consolidated CardioNet |
January 1 to
March 7 PDSHeart |
Notes
|
Pro Forma
Adjustments |
Pro Forma
Consolidated |
|||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
|
(unaudited)
|
||||||||||||
| Revenues: | ||||||||||||||||
| Net patient revenues | $ | 28,221 | $ | 4,055 | $ | | $ | 32,276 | ||||||||
| Other revenues | 299 | 14 | | 313 | ||||||||||||
|
|
|
|
|
|||||||||||||
| Total revenues | 28,520 | 4,069 | | 32,589 | ||||||||||||
| Cost of revenues | (9,743 | ) | (1,646 | ) | | (11,389 | ) | |||||||||
|
|
|
|
|
|||||||||||||
| Gross profit | 18,776 | 2,423 | 21,200 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | (2,010 | ) | | | (2,010 | ) | ||||||||||
| General and administrative | (11,974 | ) | (1,128 | ) | (a | ) | 88 | (13,014 | ) | |||||||
| Sales and marketing | (7,696 | ) | (1,098 | ) | (b | ) | 36 | (8,758 | ) | |||||||
| Amortization | (307 | ) | (32 | ) | (c | ) | (154 | ) | (493 | ) | ||||||
|
|
|
|
|
|||||||||||||
| Total expenses | (21,987 | ) | (2,258 | ) | (30 | ) | (24,275 | ) | ||||||||
|
|
|
|
|
|||||||||||||
| Income (loss) from operations | (3,211 | ) | 165 | (30 | ) | (3,075 | ) | |||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 905 | 6 | | 910 | ||||||||||||
| Interest expense | (1,314 | ) | (123 | ) | (e | ) | 80 | (1,356 | ) | |||||||
|
|
|
|
|
|||||||||||||
| Total other income (expense) | (409 | ) | (117 | ) | 80 | (446 | ) | |||||||||
| Income tax (expense) benefit | | | | | ||||||||||||
|
|
|
|
|
|||||||||||||
| Net income (loss) | $ | (3,620 | ) | $ | 48 | $ | 50 | $ | (3,521 | ) | ||||||
|
|
|
|
|
|||||||||||||
37
CardioNet, Inc.
Notes to Unaudited Pro Forma Consolidated Statement of Operations
Basis of Pro Forma Presentations
On March 8, 2007, we acquired PDSHeart, Inc. for an aggregate purchase price of $51.6 million. The $51.6 million purchase price was comprised of $44.3 million in cash at closing, $5.2 million in assumed debt, $1.4 million in transaction expenses and the assumption of a $0.7 million liability related to payments due to certain key employees of PDSHeart on March 8, 2008. In addition to the $51.6 million, we agreed to pay PDSHeart shareholders $5.0 million of contingent consideration in the event of a qualifying liquidation event, including a public offering or acquisition. Due to the contingent nature of this payment, no liability has been recorded in our historical financial statements.
The unaudited pro forma consolidated statements of operation are based on the historical financial statements of the Company and PDSHeart after giving effect to our acquisition of PDSHeart, as if it occurred on January 1, 2006, in the case of the year ended December 31, 2006, and as if the acquisition had occurred on January 1, 2007 in the case of the six months ended June 30, 2007.
The pro forma consolidated statements of operations do not give effect to any restructuring or integration costs or any potential cost savings or other operating efficiencies that could result from the acquisition.
The effects of the acquisition have been presented using the purchase method of accounting under Statement of Financial Accounting Standards ("SFAS") No. 141, Business Combinations . The total estimated purchase price of the acquisition has been allocated to assets and liabilities based on management's preliminary estimate of their fair values. The preliminary allocation of the purchase price will be subject to further adjustments, as the Company finalizes its allocation of purchase price in accordance with U.S. generally accepted accounting principles ("GAAP").
Under the purchase method of accounting, the total purchase price is allocated to tangible and identifiable intangible assets acquired and liabilities assumed based on their estimated fair values. The purchase price was allocated using information currently available, and we may adjust the preliminary purchase price. The following is a summary of our preliminary purchase price allocation (in thousands):
| Aggregate purchase price consideration | $ | 50,178 | |||
| Acquisition related costs | 1,415 | ||||
|
|
|||||
| Total purchase price | $ | 51,593 | |||
|
|
|||||
|
Net tangible assets |
|
$ |
7,334 |
||
| Identifiable intangible assets | |||||
| Trade Name | 1,810 | ||||
| Customer Relationships | 1,551 | ||||
| Non Compete Agreements | 245 | ||||
| Goodwill | 40,653 | ||||
|
|
|||||
| Total allocated purchase price | $ | 51,593 | |||
|
|
|||||
38
Pro Forma Adjustments
The following table summarizes the pro forma adjustments for the respective periods presented (in thousands):
|
|
Six Months Ended
June 30, 2007 |
Year Ended
December 31, 2006 |
||||||
|---|---|---|---|---|---|---|---|---|
| (a) Elimination of executive salary | $ | 88 | $ | 327 | ||||
| (b) Elimination of marketing salary | 36 | 113 | ||||||
| (c) Additional amortization expense | (154 | ) | (802 | ) | ||||
| (d) Reduction of interest income on officer loans | | (22 | ) | |||||
| (e) Reduction of interest expense | 80 | 445 | ||||||
| (f) Elimination of historical tax provision | | 3 | ||||||
|
|
|
|||||||
| Net reduction in net loss | $ | 50 | $ | 64 | ||||
|
|
|
|||||||
|
|
Amount
|
Useful
Life |
Annual
Amortization |
|||||
|---|---|---|---|---|---|---|---|---|
| Trade Name | $ | 1,810 | 3.0 | $ | 603 | |||
| Customer Relationships | 1,551 | 6.0 | 259 | |||||
| Non Compete Agreements | 245 | 2.0 | 123 | |||||
|
|
|
|||||||
| $ | 3,606 | $ | 985 | |||||
|
|
|
|||||||
39
SELECTED CONSOLIDATED FINANCIAL DATA
The following selected consolidated financial data should be read together with our consolidated financial statements and notes and "Management's Discussion and Analysis of Financial Condition and Results of Operations" appearing elsewhere in this prospectus. The selected consolidated financial data as of and for the years ended December 31, 2004, 2005 and 2006 are derived from our audited consolidated financial statements, which are included elsewhere in this prospectus. The selected consolidated financial data as of and for the years ended December 31, 2002 and 2003 are derived from our audited consolidated financial statements, which are not included in this prospectus. The selected consolidated statements of operations data for the six months ended June 30, 2006 and 2007 and the selected consolidated balance sheet data as of June 30, 2007 have been derived from our unaudited consolidated financial statements, which are included elsewhere in this prospectus. We have prepared the unaudited financial information set forth below on the same basis as our audited consolidated financial statements and have included all adjustments, consisting only of normal recurring adjustments, that we consider necessary for a fair presentation of our financial position and operating results for such periods. The pro forma basic net income per share data are unaudited and give effect to the conversion into common stock of all outstanding shares of our preferred stock for the periods indicated. The interim results set forth below are not necessarily indicative of results for future periods.
|
|
Actual
|
Actual
|
|||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
Year ended December 31,
|
Six months ended June 30,
|
|||||||||||||||||||||
|
|
2002
|
2003
|
2004
|
2005
|
2006
|
2006
|
2007
|
||||||||||||||||
|
|
|
|
|
|
|
(unaudited)
|
|||||||||||||||||
|
|
(in thousands, except share and per share data) |
||||||||||||||||||||||
| Statement of Operations Data: | |||||||||||||||||||||||
| Revenues: | |||||||||||||||||||||||
| Net patient revenues | $ | 126 | $ | 7,640 | $ | 20,956 | $ | 29,467 | $ | 33,019 | $ | 15,516 | $ | 28,221 | |||||||||
| Other revenues | | 283 | 1,275 | 1,471 | 904 | 632 | 299 | ||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||||||
| Total revenues | 126 | 7,923 | 22,231 | 30,938 | 33,923 | 16,148 | 28,520 | ||||||||||||||||
| Cost of revenues | 637 | 5,664 | 16,971 | 16,963 | 12,701 | 6,866 | 9,743 | ||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||||||
| Gross profit | (510 | ) | 2,259 | 5,260 | 13,975 | 21,222 | 9,283 | 18,776 | |||||||||||||||
| Operating expenses: | |||||||||||||||||||||||
| Research and development | 4,717 | 4,438 | 2,412 | 3,361 | 3,631 | 1,980 | 2,010 | ||||||||||||||||
| General and administrative | 3,713 | 7,020 | 15,252 | 13,853 | 15,631 | 7,462 | 11,974 | ||||||||||||||||
| Sales and marketing | 2,029 | 3,527 | 7,695 | 6,456 | 6,448 | 2,979 | 7,696 | ||||||||||||||||
| Amortization | | | | | | | 307 | ||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||||||
| Total operating expenses | 10,459 | 14,985 | 25,359 | 23,670 | 25,710 | 12,422 | 21,987 | ||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||||||
| Loss from operations | (10,969 | ) | (12,726 | ) | (20,099 | ) | (9,695 | ) | (4,488 | ) | (3,139 | ) | (3,211 | ) | |||||||||
| Other income (expense): | |||||||||||||||||||||||
| Interest income | 129 | 120 | 141 | 97 | 114 | 42 | 905 | ||||||||||||||||
| Interest expense | (12 | ) | (74 | ) | (989 | ) | (1,539 | ) | (2,341 | ) | (1,047 | ) | (1,314 | ) | |||||||||
|
|
|
|
|
|
|
|
|||||||||||||||||
| Total other income (expense) | 118 | 46 | (848 | ) | (1,442 | ) | (2,226 | ) | (1,005 | ) | (409 | ) | |||||||||||
|
|
|
|
|
|
|
|
|||||||||||||||||
| Net loss | $ | (10,852 | ) | $ | (12,680 | ) | $ | (20,947 | ) | $ | (11,137 | ) | $ | (6,714 | ) | $ | (4,143 | ) | $ | (3,620 | ) | ||
|
|
|
|
|
|
|
|
|||||||||||||||||
| Dividends on and accretion of mandatorily redeemable convertible preferred stock | (2,844 | ) | |||||||||||||||||||||
| Net loss applicable to common shares | $ | (10,852 | ) | $ | (12,680 | ) | $ | (20,947 | ) | $ | (11,137 | ) | $ | (6,714 | ) | $ | (4,143 | ) | $ | (6,464 | ) | ||
|
|
|
|
|
|
|
|
|||||||||||||||||
| Basic and diluted net loss per share(1): | |||||||||||||||||||||||
| Historical | $ | (2.78 | ) | $ | (2.62 | ) | $ | (3.67 | ) | $ | (1.96 | ) | $ | (1.15 | ) | $ | (0.72 | ) | $ | (1.04 | ) | ||
| Pro Forma | $ | (0.28 | ) | $ | (0.19 | ) | |||||||||||||||||
| Shares used to compute basic and diluted net loss per share(1): | |||||||||||||||||||||||
| Historical | 3,909,055 | 4,846,143 | 5,712,144 | 5,675,544 | 5,816,719 | 5,751,700 | 6,214,067 | ||||||||||||||||
| Pro Forma | 23,619,018 | 33,673,580 | |||||||||||||||||||||
40
|
|
Actual
|
Actual
|
|||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
December 31,
|
June 30,
|
|||||||||||||||||
|
|
2002
|
2003
|
2004
|
2005
|
2006
|
2007
|
|||||||||||||
|
|
|
|
|
|
|
(unaudited)
|
|||||||||||||
|
|
(in thousands) |
||||||||||||||||||
| Balance Sheet Data: | |||||||||||||||||||
| Cash and cash equivalents | $ | 14,855 | $ | 10,106 | $ | 5,718 | $ | 2,758 | $ | 3,909 | $ | 50,334 | |||||||
| Working capital | 13,961 | 11,862 | 8,666 | 3,539 | (19,122 | ) | 32,766 | ||||||||||||
| Total assets | 16,876 | 22,151 | 22,802 | 16,451 | 17,170 | 121,573 | |||||||||||||
| Total debt | 7 | 10,525 | 20,661 | 23,714 | 29,897 | 26,544 | |||||||||||||
| Mandatorily redeemable convertible preferred stock | | | | | | 109,802 | |||||||||||||
| Total stockholders' equity (deficit) | $ | 15,639 | $ | 8,000 | $ | (2,763 | ) | $ | (13,769 | ) | $ | (20,265 | ) | $ | (79,880 | ) | |||
41
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of our operations in conjunction with our consolidated financial statements and the related notes to those statements included elsewhere in this prospectus. This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. Our actual results and the timing of events may differ materially from those contained in these forward-looking statements due to a number of factors, including those discussed in the section entitled "Risk Factors," and elsewhere in this prospectus. In this discussion and analysis of our financial condition and results of operations and elsewhere in this prospectus, we present unaudited pro forma consolidated financial data relating to our acquisition of PDSHeart. This data is presented for illustrative purposes only and is not necessarily indicative of the combined financial position or results of operations that actually would have been realized had our acquisition of PDSHeart occurred prior to the covered periods. Investors should not rely on this unaudited pro forma data to predict our future results of operations as a combined company. We are on a calendar year end, and except where otherwise indicated below, "2007" refers to the year ending December 31, 2007; "2006" refers to the year ended December 31, 2006; "2005" refers to the year ended December 31, 2005; and "2004" refers to the year ended December 31, 2004.
Overview
We are the leading provider of ambulatory, continuous, real-time outpatient management solutions for monitoring relevant and timely clinical information regarding an individual's health. We incorporated in the state of California in March 1994, but did not actively begin developing our product platform until April 2000. From 2000 through 2002, we devoted substantially all of our resources to developing an integrated patient monitoring platform that incorporates a wireless data transmission network, internally developed software, FDA cleared algorithms and medical devices, and a 24-hour monitoring service center.
In February 2002, we received FDA 510(k) clearance for the first and second generation of our core CardioNet System (Mobile Cardiac Outpatient Telemetry). We opened the CardioNet Monitoring Center in Conshohocken, Pennsylvania in July 2002 and currently provide all of our CardioNet System arrhythmia monitoring solutions at that location. We established our relationship with QUALCOMM Incorporated, which provides us its wireless cellular data connectivity solution and data hosting and queuing services, in May 2003.
In November 2006, we received FDA 510(k) clearance for our third generation product, or C3, which we intend to incorporate as part of our monitoring solution beginning in the second half of 2007 and on a broader scale by January 2008. We had previously received FDA 510(k) clearance for the proprietary algorithm included in our C3 system in October 2005.
In September 2002, we were approved as an Independent Diagnostic Testing Facility for Medicare. The local Medicare carrier in Pennsylvania sets the terms for reimbursement of our CardioNet System for approximately 40 million covered lives. We have also worked to secure contracts with commercial payors. We increased the number of contracts with commercial payors from six at year-end 2003 to 41 at year-end 2004 to 97 at year-end 2005 to 114 at year-end 2006. Over this period of time, the number of covered commercial lives increased from six million at year-end 2003 to 33 million at year-end 2004 to 70 million at year-end 2005 to 102 million at year-end 2006. The current total of 154 million Medicare and commercial lives for which we have reimbursement contracts represents approximately 65% of the total covered lives in the United States. The majority of the remaining covered lives are insured by a relatively small number of large commercial insurance companies that, beginning in 2003, deemed the CardioNet System to be "experimental and investigational" and do not currently reimburse us for services provided to their beneficiaries. We believe a primary reason for the "experimental and investigational" designation has been the lack of a published peer reviewed prospective randomized
42
clinical trial that demonstrates the clinical efficacy of the CardioNet System. As a result, we significantly slowed our geographic expansion in 2005 and 2006, as we awaited results of a randomized clinical trial comparing the CardioNet System to traditional loop event monitors.
On March 8, 2007, the Company acquired all of the outstanding capital stock of PDSHeart for an aggregate purchase price of $51.6 million. The $51.6 million purchase price was comprised of $44.3 million in cash at closing, $5.2 million in assumed debt, $1.4 million of transaction expenses and the assumption of a $0.7 million liability related to payments due to certain key employees of PDSHeart on March 8, 2008. In addition to the $51.6 million of consideration, the Company agreed to pay PDSHeart shareholders $5.0 million of contingent consideration in the event of a qualifying liquidation event, including a public offering or acquisition. Due to the contingent nature of this payment, no liability has been recorded in the historical financial statements. The acquisition has been included in our consolidated results of operations since March 8, 2007. PDSHeart, now a wholly-owned subsidiary of CardioNet, provides event, Holter and pacemaker monitoring services to patients in 48 states, with a concentration of sales in the Southeast. The acquisition has broadened our geographic coverage and expanded our service offerings to include the complete range of cardiac monitoring services.
For our event, Holter and pacemaker monitoring services we have established Medicare reimbursement and we have 106 direct contracts with commercial payors, together representing 135 million covered lives.
In March 2007, we raised $110 million in mandatorily redeemable convertible preferred stock, in part, to fund the acquisition of PDSHeart.
Critical Accounting Policy and Estimates
The discussion and analysis of our financial condition and results of operations are based on our financial statements, which we have prepared in accordance with generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amount of assets and liabilities, revenues and expenses and related disclosures. We base our estimates and judgments on historical experience and on various other factors that we believe to be reasonable under the circumstances; however actual results may differ from these estimates. We review our estimates and judgments on an ongoing basis.
We believe that the following accounting policies and estimates are most critical to a full understanding and evaluation of our reported financial results. Our significant accounting policies are more fully described in Note 2 to our consolidated financial statements included elsewhere in this prospectus.
Revenue Recognition
We recognize patient service revenues from four different services: CardioNet System services and event, Holter and pacemaker monitoring services. Our largest source of revenue is CardioNet System services. For the services that we provide, revenues are recognized over the monitoring period on a daily basis.
Revenues are reported at the estimated net realizable amounts from commercial payors, physicians, patients and Medicare for services rendered. Payment arrangements for the CardioNet System include per diem and case rate payments. Payment arrangements for event, Holter and pacemaker services are generally reimbursed on a per test basis. Revenues from commercial payors are recognized based on the negotiated contractual rate or upon historical or estimated payment patterns. Our estimates for the amount of revenues to be received from each claim filed are derived from our historical experience. Our estimates are subjective and require management to exercise judgment because of our limited historical results and fluctuating reimbursement rates.
43
Payments from the Medicare and Medicaid program are based on reimbursement rates set by governmental authorities. Laws and regulations governing the Medicare and Medicaid programs are complex and subject to interpretation. Management believes that it is in compliance with all applicable laws and regulations and is not aware of any pending or threatened investigations involving allegations of potential wrongdoing.
Other revenues, consisting mainly of services provided to an affiliate of a stockholder, are recognized as the services are provided.
Accounts Receivable
Accounts receivable consists of amounts due to us from commercial payors, physicians, patients and Medicare as a result of our normal business activities. Accounts receivable are reported in the balance sheets at their estimated net realizable value, which approximates outstanding amounts, less an allowance for bad debt. We provide an allowance for bad debt for estimated losses resulting from unwillingness of commercial payors, physicians or patients to make payment for services. We estimate the allowance for bad debt based upon historical collections experience, write-offs and an allowance percentage of our accounts receivable by aging category. Uncollectible account balances are written off against the allowance after all means of collections have been exhausted and the potential for recovery is considered remote. The provision for bad debt is included in general and administrative expense and the allowance for bad debt is presented as a contra account to accounts receivable. Due to the subjective nature, our estimates of the net realizable value of accounts receivable and the related allowance for bad debt require considerable judgement.
Stock Based Compensation
Prior to 2006, we accounted for stock based compensation in accordance with Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees (APB 25), and the related interpretations. Under APB 25, no compensation expense was recognized if the exercise price of our stock options equaled or exceeded the fair value of the underlying common stock at the date of grant. We provided pro forma disclosures in our financial statements as required by SFAS No. 123, Accounting for Stock Based Compensation (SFAS 123), as amended by SFAS No. 148, Accounting for Stock Based Compensation- Transition and Disclosure , related to fiscal periods prior to January 1, 2006.
The fair value of our common stock during the years ended December 31, 2004 and December 31, 2005 was determined by our board of directors with the assistance of management. We did not obtain contemporaneous valuations by an unrelated valuation specialist during this period because we were focused on market development and our financial and managerial resources were limited. The board of directors and management considered numerous objective and subjective factors in the assessment of fair value including the prices of our preferred stock that was sold to investors and the rights, preferences and privileges of the preferred stock and the common stock, our financial condition and financial results during the relevant periods, and the status of strategic initiatives to increase the market acceptance of our service. These estimates involved a significant level of judgment.
In December 2004, The Financial Accounting Standards Board (FASB) issued SFAS No. 123R, Stock Based Payment , (SFAS 123R), which replaced SFAS 123, and supersedes APB 25. SFAS 123R requires all share based payments to employees, including grants of employee stock options, to be recognized in the financial statements based on their fair values beginning with the first annual period after December 15, 2005. SFAS 123R requires that an entity measure the fair value of equity based service awards at the grant date and recognize the cost of such award over the period during which the employee is required to provide service in exchange for the award (vesting period).
We adopted SFAS 123R on January 1, 2006 using the modified prospective method which requires that all new stock based awards granted subsequent to December 31, 2005 be recognized in the financial statements at fair value. The impact of recognizing stock based awards was dependent upon
44
the level of stock based awards issued, the market price which was determined by an independent valuation firm and other judgmental assumptions used such as forfeiture rates.
The per share weighted average fair value of the options granted during 2006 was estimated at $0.44 on the date of grant using the Black-Scholes option pricing model with the following weighted average assumptions, which are based on company history or industry comparative information:
Since our stock is not publicly traded, the expected volatility was calculated for each date of grant based on an alternative method. We identified similar public entities for which share price information is available and have considered the historical volatility of these entities' share price in estimated expected volatility.
We estimated the fair value of our common stock during 2006 by utilizing retrospective third party valuations. The valuation methodology utilized the income and the market approach with the ultimate valuation being a probability weighted expected return of the two methods. The income approach involves projecting future cash flows, discounting them to present value using a discount rate based on a risk adjusted weighted average cost of capital of comparable companies. The projection of future cash flows and the determination of an appropriate discount rate involves a significant level of judgment. The market approach compares the subject business to similar businesses that have been sold or what is commonly known as comparables. This could be based on prior business sales of similar companies or the relative valuation of similar companies in the public markets discounted back to account for the time period until a liquidity event is forecasted to occur. The market approach also involves a significant level of judgment. The retrospective valuation of our stock yielded a weighted average valuation of $0.81 during 2006.
Valuation of Goodwill and Other Intangible Assets
On March 8, 2007, we acquired PDSHeart for an aggregate purchase price of $51.6 million. The $51.6 million purchase price was comprised of $44.3 million in cash at the closing, $5.2 million in assumed debt, $1.4 million of transaction expenses, and the assumption of a $0.7 million liability related to payments due to certain key employees of PDSHeart on March 8, 2008. In addition to the $51.6 million of consideration, the Company agreed to pay PDSHeart shareholders $5.0 million of contingent consideration in the event of a qualifying liquidation event, including a public offering or acquisition. The acquisition was accounted for as a purchase in accordance with SFAS No. 141, Business Combinations (SFAS 141). See Note 3 to our consolidated financial statements for additional information regarding the allocation of the purchase price we paid for PDSHeart.
In accordance with SFAS 141, Business Combinations , we identify and value intangible assets that we acquire in business combinations, such as customer arrangements, customer relationships, trademarks and non-compete agreements, that arise from contractual or other legal rights or that are capable of being separated or divided from the acquired entity and sold, transferred, licensed, rented or exchanged. We contracted with a third party valuation firm to assist management in valuing these assets. The fair value of identified intangible assets is based upon an estimate of the future economic benefits expected to result from ownership, which represents the amount at which the assets could be bought or sold in a current transaction between willing parties, that is other than a forced or liquidation sale.
45
In accordance with SFAS No. 142, Goodwill and Other Intangible Assets , we intend to test our goodwill for impairment annually or more frequently if events or circumstances indicate impairment may exist.
Statement of Operations Overview
Revenues
Our principal source of revenues is patient revenue from cardiac monitoring services. The amount of revenue generated is based on the number of patients enrolled through physician prescriptions and the rates reimbursed to us by commercial payors, physicians, patients and Medicare. Reimbursement rates are set by CMS on a case rate basis for the Medicare program and through negotiations with commercial payors who typically pay a daily monitoring rate. From 2002 through 2007, our average case rate for monitoring Medicare patients has remained relatively stable. We expect pricing to decline over time in a manner consistent with the introduction and penetration of a premium priced service, due to competition, introduction of new technologies and the potential addition of larger commercial payors. Since our CardioNet System services are relatively new and the reimbursement status is evolving, our revenues are subject to fluctuations due to increases or decreases in rates and decisions by payors regarding reimbursement.
For the event, Holter and pacemaker monitoring market we expect the price to be flat or declining as the new generation technology gains wider acceptance in the market. In addition, the established 2007 Medicate rates compared to 2006 for our event monitoring services declined by 3% to 8%, depending on the type of service, and our Holter monitoring services declined 8%. Based on current proposed Medicare rates for 2008 through 2010 we expect this downward reimbursement trend to continue for these services.
We believe the CardioNet System monitoring system revenues will increase as a percentage of revenues going forward as we emphasize this service, continue our geographic expansion and achieve greater market penetration in existing markets. We expect that the event, Holter and pacemaker monitoring services revenues will be flat or declining in absolute terms as the old technology is replaced and therefore decrease as a percentage of revenues going forward. Other revenue consists mainly of web hosting services provided to an affiliate of a stockholder. We believe that other revenues will be flat or declining in absolute terms and therefore decrease as a percentage of revenues going forward. Our revenues are seasonal, as the volume of prescriptions tends to slow down in the summer months due to the more limited use of our monitoring solutions as physicians and patients vacation.
Gross Profit
Gross profit consists of revenues less the cost of revenues which includes:
46
Our gross profit margins have increased significantly from 24% in 2004 to 45% in 2005 to 63% in 2006. The major reasons for the growth in our gross profit margins from 2004 to 2006 are as follows:
For the six months ended June 30, 2007, our gross profit margin was 66%. In general, we expect gross profit margins on the CardioNet System services to remain flat or increase, assuming no changes in reimbursement rates. For our event and Holter monitoring services, we expect gross profit margins to decrease as reimbursement rates decline as currently proposed by CMS.
Sales and Marketing
Sales and marketing expense consists primarily of salaries, benefits and stock-based compensation related to account executives, marketing personnel and contracting personnel, account executive commissions, travel and other reimbursable expenses, and marketing programs such as trade shows and marketing campaigns.
We did not expand geographically in 2005 or 2006 while awaiting the results of our randomized clinical trial. Our sales force had 20 account executives at year-end 2005 and 27 account executives at December 31 2006. Following the completion of our randomized clinical trial and the PDSHeart acquisition we made a significant investment in sales and marketing by increasing the number of account executives in new geographies. We had 77 account executives as of June 30, 2007 and expect to have 88 account executives by December 31, 2007. We currently have account executives covering 48 states. We also plan to increase our marketing activities. As a result, we expect that sales and marketing expenses will increase in absolute terms, but will decrease as a percentage of revenues going forward.
Research and Development
Research and development expense consists primarily of salaries, benefits and stock-based compensation of personnel and the cost of subcontractors who work on the development of the hardware and software for our next generation monitors, enhance the hardware and software of our existing monitors and provide quality control and testing. The expenses related to the randomized clinical trial are also included in research and development expenses. We expect that research and development expenses will increase in absolute terms but decrease as a percentage of revenues going forward.
General and Administrative
General and administrative expense consists primarily of salaries, benefits and stock based compensation related to general and administrative personnel, professional fees primarily related to legal and audit fees, facilities expenses and the related overhead, and bad debt expense. We expect that general and administrative expenses will increase in absolute terms due to the significant planned investment in infrastructure to support our growth and the additional expenses related to becoming a publicly traded company, including the increased cost of compliance and increased audit fees resulting
47
from the Sarbanes-Oxley Act. As a percentage of revenues, we expect general and administrative expenses to decrease as we grow.
Income Taxes
We have net deferred income tax assets totaling approximately $30.0 million at the end of 2006 consisting primarily of federal and state net operating loss and credit carryforwards. The federal and state net operating loss carryforwards, if unused, will begin to expire in 2010. The federal and state credit carryforwards, if unused, will expire in 2022. Due to uncertainty regarding the ultimate realization of these net operating loss and credit carryforwards and other deferred income tax assets, we have established a full valuation allowance for these assets and will recognize the benefits only as reassessment indicates the benefits are realizable.
Non-recurring Expenses
A competitor initiated a patent infringement lawsuit against us in November 2004, which we defended and ultimately settled in March 2006. We incurred legal-related expenses related to this lawsuit of $0.1 million in 2004, $1.2 million in 2005 and $0.6 million in 2006.
Results of Operations
Six Months Ended June 30, 2007 and 2006
Revenues. Total revenues for the six months ended June 30, 2007 increased to $28.5 million from $16.1 million for the six months ended June 30, 2006, an increase of $12.4 million, or 76%. This increase of $12.4 million included an increase of $12.7 million in patient revenues, of which $7.2 million was from the event and Holter monitoring business and $5.5 million was CardioNet System revenues. This increase in patient revenues was offset by a decrease of $0.3 million in special project revenues. The increase in patient revenues was due mainly to geographic expansion, increased prescriptions following publication of the clinical trial and the acquisition of PDSHeart. Special projects revenues decreased due to lower contractual rates.
Cost of Revenues. Cost of revenues for the six months ended June 30, 2007 were $9.7 million compared to $6.9 million for the six months ended June 30, 2006. This increase of $2.8 million, or 42%, is due to the acquisition of PDSHeart. Cost of sales was 34% of revenues in June 2007 versus 43% in June 2006. This decline is due mainly to the full period effect of our telephonic hook-up process in 2007, which was still in transition during the first 6 months of 2006.
Gross Profit. Gross profit increased to $18.8 million for the six months ended June 30, 2007, or 66% of revenues, from $9.3 million for the six months ended June 30, 2006, or 57% of revenues.
Sales and Marketing Expense. Sales and marketing expenses were $7.7 million for the six months ended June 30, 2007 compared to $3.0 million for the six months ended June 30, 2006. The increase of $4.7 million is due to increased costs from a larger sales force which is mainly a result of the PDSHeart acquisition and the introduction of a marketing campaign aimed at promoting our positive clinical trial results. As a percent of total revenues, sales and marketing expenses were 27% for the six months ended June 30, 2007 compared to 19% for the six months ended June 30, 2006.
Research and Development Expense. Research and development expenses remained flat at $2.0 million for the six months ended June 30, 2007 and for the six months ended June 30, 2006. As a percent of total revenues, research and development expenses declined to 7% for the six months ended June 30, 2007 compared to 12% for the six months ended June 30, 2006.
General and Administrative Expense. General and administrative expenses (including amortization) increased to $12.3 million for the six months ended June 30, 2007 from $7.5 million for the six months ended June 30, 2006. This increase of $4.8 million, or 64%, was primarily due to the provision for bad debt and increased facilities and overhead from the acquisition of PDSHeart. In addition, the provision for bad debt increased $1.2 million due to higher volume and additional provision for uncollectible accounts. As a percent of total revenues, general and administrative expenses declined to 43% for the six months ended June 30, 2007 compared to 46% for the six months ended June 30, 2006.
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Total Interest Expense, Net. Interest expense, net decreased to $0.4 million for the six months ended June 30, 2007 from $1.0 million for the six months ended June 30, 2006. This decrease is due to interest income received from the excess funds generated from our private placement in March 2007 and retirement of the PDSHeart debt obligations assumed in the acquisition.
Income Taxes. We had no income tax benefit or expense for the six months ended June 30, 2007 and for the six months ended June 30, 2006.
Net Loss. Net loss decreased to $3.6 million for the six months ended June 30, 2007 from $4.1 million for the six months ended June 30, 2006. As a percent of total revenues, net loss was 13% for the quarter ended June 30, 2007 compared to 26% for the six months ended June 30, 2006.
Years Ended December 31, 2006 and 2005
Revenues. Total revenues for 2006 increased to $33.9 million from $30.9 million in 2005, an increase of $3.0 million, or 10%. This increase of $3.0 million included an increase of $3.6 million in patient revenues offset by a decrease of $0.6 million in special project revenues. Patient revenues increased due to successful implementation of a new sales strategy and increased penetration in existing markets, which translated to an increase in the total patients serviced. Special project revenues decreased due to a change in the negotiated contract rate.
Cost of Revenues. Cost of revenues for 2006 were $12.7 million compared to $17.0 million in 2005. This decrease of $4.3 million, or 25%, is attributable to a shift in our patient hook-up model from in-home to telephonic, lower device transportation costs and cellular airtime costs following contract renegotiation, and a decrease in the number of employees providing services and customer support as we transitioned from in-home to telephonic hookups. We decreased headcount in our service operation responsible for monitoring patients, providing logistical and customer support and supporting product distribution from 155 people at year-end 2005 to 129 people at year-end 2006. As a percent of total revenues, cost of revenues decreased to 37% in 2006 compared to 55% in 2005.
Gross Profit. Gross profit increased to $21.2 million in 2006, or 63% of revenues, from $14.0 million in 2005, or 45% of revenues.
Sales and Marketing Expense. Sales and marketing expenses were $6.4 million in 2006 compared to $6.5 million in 2005. Expenses remained relatively flat since we did not expand the sales force in 2006 as we awaited completion of the randomized clinical trial. As a percent of total revenues, sales and marketing expenses decreased to 19% in 2006 compared to 21% in 2005.
Research and Development Expense. Research and development expenses increased to $3.6 million in 2006 from $3.4 million in 2005. This increase of $0.2 million, or 7%, was due to continued development of the third generation device, C3. As a percent of total revenues, research and development expenses remained consistent at 11% in 2006 and 2005.
General and Administrative Expense. General and administrative expenses increased to $15.6 million in 2006 from $13.9 million in 2005. This increase of $1.7 million, or 12%, was primarily due to relocation expenses, consulting services related to reimbursement and increased provision for bad debt. Headcount was held relatively flat in 2006 versus 2005. As a percent of total revenues, general and administrative expenses increased to 46% in 2006 compared to 45% in 2005.
Total Interest Expense, Net. Interest expense, net increased to $2.2 million in 2006 from $1.4 million in 2005. This increase of $0.8 million was due to an increase in borrowings in order to fund our operations.
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Income Taxes. We had no income tax benefit or expense for the years ended December 31, 2006 and 2005. As of December 31, 2006 and 2005, we had net deferred income tax assets totaling approximately $30.0 and $27.5 million, respectively, consisting primarily of federal and state net operating loss carryforwards.
Net Loss. Net loss decreased to $6.7 million in 2006 from $11.1 million in 2005. As a percent of total revenues, net loss was 20% in 2006 compared to 36% in 2005.
Years Ended December 31, 2005 and 2004
Revenues. Total revenues for 2005 increased to $30.9 million from $22.2 million in 2004, an increase of $8.7 million, or 39%. This increase of $8.7 million included an increase of $8.5 million in patient revenues and a $0.2 million increase in special project revenues. Patient revenues increased due to a 33% increase in patient enrollment with no geographic expansion. Special project revenues remained relatively flat due to negotiated contract pricing.
Cost of Revenues. Cost of revenues for both 2005 and 2004 were $17.0 million. Expenses remained flat as increasing monitoring expenses were offset by decreases in patient service delivery as we began to implement the switch from in-home to telephonic hook-ups. We had 155 people in our service operation at December 31, 2005 monitoring patients, providing logistical and customer support and supporting product distribution compared to 162 people at December 31, 2004. As a percent of total revenues, cost of revenues decreased to 55% in 2005 compared to 76% in 2004.
Gross Profit. Gross profit increased to $14.0 million in 2005, or 45% of revenues, from $5.3 million in 2004, or 24% of revenues.
Sales and Marketing Expense. Sales and marketing expenses were $6.5 million in 2005 compared to $7.7 million in 2004. This decrease of $1.2 million, or 16%, was due to restructuring activities which reduced sales and marketing personnel by 27%. This reduction of headcount was achieved in markets which had limited reimbursement and were not providing a sufficient level of business. As a percent of total revenues, sales and marketing expenses decreased to 21% in 2005 compared to 35% in 2004.
Research and Development Expense. Research and development expenses increased to $3.4 million in 2005 from $2.4 million in 2004. This increase of $1.0 million, or 40%, was due to the development expenses related to our C3 device. As a percent of total revenues, research and development expenses were 11% in both 2005 and 2004.
General and Administrative Expense. General and administrative expenses decreased to $13.9 million in 2005 from $15.3 million in 2004. This decrease of $1.4 million, or 9%, was primarily due to restructuring activities which reduced support personnel by 19%. As a percent of total revenues, general and administrative expenses decreased from 45% in 2005 compared to 69% in 2004.
Total Interest Expense, Net. Interest expense, net increased to $1.4 million in 2005 from $0.8 million in 2004. This increase of $0.6 million was due to an increase in our borrowing to fund our operations and a decrease in interest income from 2004.
Income Taxes. We had no income tax benefit or expense for the years ended December 31, 2006 and 2005. As of December 31, 2005 and 2004, we had net deferred income tax assets totaling approximately $27.5 million and $22.2 million, respectively consisting primarily of federal and state net operating loss carryforwards.
Net loss. Net loss decreased to $11.1 million in 2005 as compared to $20.9 million in 2004. As a percent of total revenues, net loss was 36% in 2005 compared to 94% in 2004.
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Liquidity and Capital Resources
From our inception in 1999 through June 30, 2007, we did not generate sufficient cash flows to fund our operations and the growth in our business. As a result, our operations have been financed primarily through the private placement of equity securities and both long-term and short term debt financings. Through June 30, 2007, we funded our business primarily through the following:
On July 3, 2006, we entered into a loan and security agreement with Silicon Valley Bank that provides us with a revolving line of credit and a term loan. The revolving line of credit is available in an amount up to $2.0 million less the amount of any letters of credit issued by Silicon Valley Bank on our behalf. We may receive advances under the revolving line of credit through July 1, 2008, which is the maturity date of the line of credit. Any amounts we borrow under the revolving line of credit may be repaid and reborrowed by us at any time until the maturity date. At the maturity date, all principal and interest accrued under the revolving line of credit shall become due and payable. The interest rate on amounts outstanding pursuant to the revolving line of credit is equal to Silicon Valley Bank's prime rate plus 0.5%. As of December 31, 2006, the amount outstanding pursuant to the revolving line of credit was approximately $1.9 million. As of June 30, 2007, no amounts were outstanding pursuant to the revolving line of credit.
Pursuant to the term loan we were permitted to make a one-time draw down of $3.0 million on July 3, 2006. We are required to repay the term loan in 36 equal installments of principal, plus monthly payments of accrued interest. The interest rate became fixed at the time we drew down the term loan and is equal to 8.63%. As of December 31, 2006, the amount outstanding pursuant to the term loan was approximately $3.0 million. We intend to repay this term loan with the proceeds of this offering.
Our financing arrangements with Silicon Valley Bank are secured by substantially all of our assets and require us to adhere to various financial covenants, including minimum tangible net worth and minimum liquidity. As of June 30, 2006, we were in compliance with such covenants.
Our financing arrangements with Silicon Valley Bank are subject to events of default, including if a material adverse change occurs in our financial condition, if there is a material impairment of the prospect of repayment of any portion of the indebtedness or if Silicon Valley Bank determines, based upon information available to it and in its reasonable judgement, that there is a reasonable likelihood that we will fail to comply with one or more of the financial covenants. If an event of default occurs, all amounts due under the term loan agreement, at Silicon Valley Bank's option, would become due and payable.
As of June 30, 2007, our principal sources of liquidity were cash totaling $50.3 million and net accounts receivable of $16.8 million.
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Cash Flows from Operating Activities
Net cash used in operating activities during the six months ended June 30, 2007 and the years ended December 31, 2006, 2005 and 2004 was $1.7 million, $4.3 million, $5.5 million and $15.3 million, respectively. For the year ended December 31, 2006, cash was used in operations primarily by:
These cash uses were partially offset by:
For the six months ended June 30, 2007, cash was used in operations primarily by:
These cash uses were partially offset by:
Cash Flows from Investing Activities
Net cash used in investing activities during the six months ended June 30, 2007 and the years ended December 30, 2006, 2005 and 2004 was $50.5 million, $0.9 million, $0.6 million and $9.4 million, respectively. For the year ended December 31, 2006, cash was used in investing activities primarily by:
For the six months ended June 30, 2007, cash was used in investing activities primarily by:
Cash Flows from Financing Activities
Net cash provided by financing activities during the six months ended June 30, 2007, and the years ended December 30, 2006, 2005 and 2004 was $98.6 million, $6.4 million, $3.2 million and $20.3 million, respectively. For the year ended December 31, 2006, cash was provided by financing activities primarily by:
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For the six months ended June 30, 2007, cash was provided by financing activities primarily by:
In the short term, we anticipate that we will continue to experience losses from operations. However, we believe that the net proceeds from this offering, together with our existing cash and cash equivalent balances and revenues from our operations, will be sufficient to meet our anticipated cash requirements for the foreseeable future.
Our future funding requirements will depend on many factors, including:
To the extent that we raise additional capital by issuing equity securities, our stockholders' ownership will be diluted. In addition, if we determine that we need to raise additional capital, such capital may not be available on reasonable terms, or at all. If we raise additional funds by issuing equity securities, substantial dilution to existing stockholders would likely result. If we raise additional funds by incurring additional debt financing, the terms of the debt may involve significant cash payment obligations as well as covenants and specific financial ratios that may restrict our ability to operate our business.
Contractual Obligations and Commitments
The following table describes our long-term contractual obligations and commitments as of December 31, 2006:
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Payments due by period
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Contractual obligations
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Total
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2007
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2008
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2009
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2010
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2011
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Beyond
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(in thousands)
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| Interest and principal payable under loan agreements | $ | 29,031 | $ | 26,146 | $ | 1,187 | $ | 1,098 | $ | 600 | $ | | $ | | |||||||
| Operating lease obligations | 9,823 | 1,259 | 1,825 | 1,577 | 1,594 | 1,437 | 2,131 | ||||||||||||||
| Capital lease obligations | 210 | 56 | 52 | 52 | 50 | | | ||||||||||||||
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| Total | $ | 39,064 | $ | 27,461 | $ | 3,064 | $ | 2,727 | $ | 2,244 | $ | 1,437 | $ | 2,131 | |||||||
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From time to time we may enter into contracts or purchase orders with third parties under which we may be required to make payments. Our payment obligations under certain agreements will depend on, among other things, the progress of our development programs. Therefore, we are unable at this time to estimate with certainty the future costs we will incur under these agreements or purchase orders.
Recent Accounting Pronouncements
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS 157), which defines fair value, establishes a framework for measuring fair value under generally accepted accounting principles, and expands disclosures about fair value measurements. SFAS 157 applies to other accounting pronouncements that require or permit fair value measurements. The new guidance is effective for financial statements issued for fiscal years beginning after November 15, 2007, and for interim periods within those fiscal years. We are currently evaluating the requirements of SFAS 157; however, we do not believe that its adoption will have a material effect on our consolidated financial statements.
In June 2006, the FASB issued Interpretation No. 48, Accounting for Uncertainty in Income Taxes (FIN 48), which prescribes detailed guidance for the financial statement recognition, measurement, and disclosure of uncertain tax positions recognized in an enterprise's financial statements in accordance with FASB Statement No. 109, Accounting for Income Taxes . Tax positions must meet a more-likely-than-not recognition threshold at the effective date to be recognized upon the adoption of FIN 48 and in subsequent periods. FIN 48 will be effective January 1, 2007 for the Company, and the provisions of FIN 48 will be applied to all tax positions accounted for under Statement No. 109 upon initial adoption. The cumulative effect of applying the provisions of this interpretation will be reported as an adjustment to the opening balance of retained earnings for that fiscal year. The Company does not expect FIN 48 to have a material impact on its financial statements.
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and Financial Liabilities-Including an Amendment of FASB Statement No. 115 ("SFAS 159"). SFAS 159 permits entities to choose fair value measurement for many financial instruments and certain other items as of specified election dates. Business entities will thereafter report in earnings the unrealized gains and losses on items for which the fair value option has been chosen. The fair value option may be applied instrument by instrument but may not be applied to portions of instruments and is irrevocable unless a new elections date occurs. SFAS 159 is effective for the Company beginning January 1, 2008. The Company is currently evaluating the potential impact of adoption of SFAS 159, but does not expect that it will have a material effect on the consolidated financial statements.
Off-Balance Sheet Arrangements
As of June 30, 2007 and as of December 31, 2006, 2005 and 2004, we did not have any relationships with unconsolidated entities or financial partnerships, such as entities referred to as structured finance or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.
Related Party Transactions
For a description of our related party transactions, see the "Related Party Transactions" section of this prospectus.
Quantitative and Qualitative Disclosures about Market Risk
The primary objective of our investment activities is to preserve our capital for the purpose of funding operations while at the same time maximizing the income we receive from our investments without significantly increasing risk. To achieve this objective our investment policy allows us to maintain a portfolio of cash equivalents and short term investments in a variety of securities including money market funds and corporate debt securities. Due to the short term nature of our investments, we believe we have no material exposure to interest rate risk.
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Overview
We are the leading provider of ambulatory, continuous, real-time outpatient management solutions for monitoring relevant and timely clinical information regarding an individual's health. We have raised over $200 million of capital and spent seven years developing a proprietary integrated patient monitoring platform that incorporates a wireless data transmission network, internally developed software, FDA cleared algorithms and medical devices, and a 24-hour digital monitoring service center. Our initial efforts are focused on the diagnosis and monitoring of cardiac arrhythmias, or heart rhythm disorders, with a solution that we market as the CardioNet System.
We believe that the CardioNet System's continuous, heartbeat-by-heartbeat monitoring is a fundamental advancement in arrhythmia monitoring, with the potential to transform an industry that has historically relied on memory-constrained, intermittent digital or tape recorders, such as event monitors and Holter monitors. Existing technologies have one or more drawbacks including failure to provide real-time data, memory constraints, frequent inaccurate diagnoses and an inability to monitor patient compliance and interaction. We believe these drawbacks lead to suboptimal diagnostic yields which adversely impact clinical outcomes and health care costs. In a recently completed randomized clinical trial, the CardioNet System detected clinically significant arrhythmias nearly three times as often as traditional loop event monitors in patients who had previously experienced negative or inconclusive Holter monitoring.
The CardioNet System incorporates a lightweight patient-worn sensor attached to electrodes that capture two-lead electrocardiogram, or ECG, data measuring electrical activity of the heart and communicates wirelessly with a compact, handheld monitor. The monitor analyzes incoming heartbeat-by-heartbeat information from the sensor on a real-time basis by applying proprietary algorithms designed to detect arrhythmias. When the monitor detects an arrhythmic event, it automatically transmits the ECG to the CardioNet Monitoring Center, even in the absence of symptoms experienced by the patient and without patient involvement. At the CardioNet Monitoring Center, which operates 24 hours a day and 7 days per week, experienced certified cardiac monitoring specialists analyze the sent data, respond to urgent events and report results in the manner prescribed by the physician. The CardioNet System currently stores 96 hours of ECG data, in contrast to 10 minutes for a typical event monitor. We are in the process of upgrading our monitors to provide expanded storage of 21 days of ECG data. The CardioNet System employs two-way wireless communications, enabling continuous transmission of patient data to the CardioNet Monitoring Center and permitting physicians to remotely adjust monitoring parameters and request previous ECG data from the memory stored in the monitor.
Since our commercial introduction of the CardioNet System in January 2003, physicians have enrolled over 80,000 patients in the CardioNet System. Through the end of 2006, we marketed our solution in select territories, principally in 23 states in the Mid-Atlantic, Northeast and Midwest. In addition, we have achieved reimbursement at payment levels that we believe reflects the clinical efficacy of the CardioNet System relative to existing technologies. We have secured direct contracts with 154 commercial payors, which, combined with Medicare, represent more than 154 million covered lives as of June 30, 2007.
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clinical trial. Since publication of the trial results in March 2007, we have secured contracts with three of these 21 payors, representing over 11 million covered lives.
We believe that our integrated patient monitoring platform can be utilized for future applications in multiple markets beyond arrhythmia monitoring. We believe that we have growth opportunities in clinical trial monitoring, where we have developed additional FDA-cleared algorithms for specific cardiac data required in clinical trials, and in comprehensive disease management for congestive heart failure, diabetes and other diseases. We believe that our technology could also be used to create "instant telemetry beds" in hospitals, particularly in rural hospitals, step-down units or skilled nursing facilities to help cope with acute nursing shortages by reducing the number of nurses needed to oversee ECG monitoring. In addition, the significant capital equipment costs associated with in-facility based ECG telemetry could be avoided through the use of the CardioNet System.
Industry Overview
Overview of Cardiac Arrhythmias
An arrhythmia is categorized as a temporary or sustained abnormal heart rhythm that is caused by a disturbance in the electrical signals in the chambers of the heart. Proper administration of electrical signals to the heart is necessary to ensure effective heart function. There are two main categories of arrhythmia: tachycardia, meaning too fast a heartbeat, and bradycardia, meaning too slow a heartbeat.
Arrhythmias affect more than four million people in the United States. According to the American Heart Association, arrhythmias result in more than 780,000 hospitalizations and contribute to approximately 480,000 deaths each year. A number of factors can contribute to arrhythmias including cardiovascular disease, high blood pressure, diabetes, smoking, excessive consumption of alcohol or caffeine, illicit drug abuse or stress. An arrhythmia may be a symptom of serious cardiovascular disease
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and, if left undiagnosed and untreated, can lead to stroke, other serious complications or even death. Examples of arrhythmias and their consequences include:
The ability to diagnose or rule out an arrhythmia as a symptom of a cardiac condition is important both to treat those patients with serious cardiovascular diseases as well as to identify those patients that may not require further medical attention.
Evolution of Traditional Arrhythmia Monitoring Technologies
Arrhythmias may be diagnosed either in a physician's office or other health care facility or remotely by monitoring a patient's heart rhythm. Typically, physicians will initially administer a resting ECG that monitors the electrical impulses in a patient's heart. If a physician determines that a patient needs to be monitored for a longer period of time to produce a diagnosis, the physician will typically prescribe an ambulatory cardiac monitoring device, such as a Holter monitor or an event monitor.
Some physicians own their own ambulatory cardiac monitoring devices and provide ambulatory monitoring services directly to their patients, while other physicians outsource the services to third party providers. In the wake of increasing legal and compliance requirements surrounding ambulatory cardiac monitoring, including a 2003 Medicare decision requiring 24 hour per day monitoring stations, the increasing trend is for physicians and hospitals to outsource their monitoring needs to independent providers.
If either the Holter monitor or event monitor are negative or inconclusive and the physician still suspects an arrhythmia as the cause of the symptom, the physician may decide to prescribe additional, more expensive testing or hospitalize the patient in a telemetry unit (continuously attended ECG monitoring). In-hospital telemetry is expensive and therefore is only utilized selectively and for short time periods, and the monitored data is often not reflective of real-life cardiac activity.
Holter Monitors
A Holter monitor is an ambulatory cardiac monitoring device, first used in 1961, that is generally worn by a patient for a one or, in rare instances, two day period in order to record continuous ECG data. After the one or two day period, the magnetic or digital storage, or other medium containing the data recorded by this device, is delivered by hand, mail or internet for processing and analysis by the physician or a third party service provider. Despite the advent of newer technologies, Holter monitoring
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continues to be used today for patients whose suspected arrhythmia is believed to occur many times during the course of a day, in which case a Holter is often effective or adequate. However, for a patient that has an unpredictable or intermittent arrhythmia, a Holter may not provide clinically useful information due to the insufficient duration of the monitoring period. In addition, as a result of the typical one to three day reporting delay and the lack of real-time physician notification, patients may not receive timely diagnosis of their condition. Any artifact, or noise, in the data will not be discovered until t