|By Business Wire||
|March 17, 2014 04:00 PM EDT||
MELA Sciences, Inc. (NASDAQ:MELA), (the “Company”), developer of MelaFind®, an FDA approved optical diagnostic device that assists dermatologists in the diagnosis of melanoma, today announced financial results for the fourth quarter and year ended December 31, 2013.
The Company will host a conference call at 4:30pm ET to review results. Please dial 877-303-9205 (domestic) or 760-536-5226 (international). A live webcast will be available at: www.melasciences.com. If you are unable to participate during the live call and webcast, a replay will be archived and available for approximately 90 days after call.
Fourth Quarter and Full Year 2013 Financial Results
Net Revenues for the three months ended December 31, 2013 were $140,000 compared to $122,000 for the same period last year, an increase of 14.75%. Cost of revenue for the fourth quarter was $914,000 down 5.87% from $971,000 in the prior year. Total operating expenses for the fourth quarter were $3.6 million down 30.58% from last year, which was due to management’s cost reduction and cash conservation policy put in place mid-year.
The Company’s net loss for the three months ended December 31, 2013 was $4.6 million, or $0.09 per diluted share, compared to a net loss of $6.1 million, or $0.19 per diluted share, for the same period in 2012.
Net Revenues for the twelve months ended December 31, 2013 were $536,000 compared to $278,000 reported for the same period in 2012, an increase of 92.81%. Cost of revenue for the full year was $4.3 million compared to $2.0 million for 2012 and primarily relates to increased depreciation expense for units placed during the year. Total operating expenses for 2013 were $20.3 million down 3.02% from last year and included an impairment charge taken in the third quarter of approximately $1 million related to our MelaFind® systems placed in the field.
The net loss for 2013 was $25.9 million or $0.60 per share compared to $22.7 million or $0.74 per share in 2012. The net loss for 2013 includes the $1 million non-cash impairment charge mentioned above, a write-off of unamortized loan costs of approximately $1 million relating to the pay-off of long term debt, increased interest expense of $0.6 million also attributed to the long term debt and a non-cash charge of $0.3 million primarily related to warrants issued in the October 2013 financing that must be accounted for as a liability.
Fourth Quarter and Full Year 2013 Highlights
On October 31, 2013 the Company closed on a $6 million registered direct offering, which resulted in net proceeds to the Company of approximately $5.5 million. As part of the offering the Company sold just over 4.2 million shares of common stock and prefunded warrants to purchase up to 4.3 million shares of common stock. The Company also issued additional warrants to purchase up to 6.9 million shares of common stock, which could result in proceeds of $5.8 million, if exercised.
In November, Rose Crane was appointed President and CEO of the Company bringing over 30 years of healthcare industry experience in fields such as pharmaceuticals, medical devices and healthcare services. As President and CEO of Epocrates, a healthcare technology firm, she directed the efforts to take the company public.
In October, Dr. Darrell Rigel, Clinical Professor of Dermatology at New York University, Langone Medical Center was appointed Chief Medical Advisor to the Board. Dr. Rigel also serves as a Regional Chair of the Massachusetts Institute of Technology Education Council.
In the fourth quarter, MELA Sciences participated in various clinical conferences and meetings including the following:
- MelaFind® was showcased at the American Society of Dermatologic Surgery Annual Meeting, the meeting was held over four days and provided attendees the opportunity to stay current on innovative devices, news and technology;
- presented four Poster Presentations at the 32nd Annual Fall Clinical Dermatology Conference in Las Vegas and held its first Clinical Advisory meeting, which announced the launch of a new user study, called the MelaFind® Experience Trial (MET–1);
- participated in the Washington D.C. Dermatological Society’s Fall Clinical Conference, a hands-on symposium involving live patient case studies and pathology analysis; and
- in conjunction with the Mount Sinai Winter Dermatology Symposium, hosted its second Clinical Advisory Meeting chaired by Dr. Gary Goldenberg, Medical Director of Mount Sinai’s Dermatology Faculty Practice.
“Having joined MELA Sciences just before the end of the year, I can only say thank you to everyone from management to staff for their diligence and hard work throughout 2013. The market proved to be a difficult one and ultimately the Company realized that a refocused strategy was in order. So I am happy to say we have initiated a new business plan and a new business model that will serve not only MELA but dermatologists and most importantly the patients at high risk for melanoma,” said Rose Crane, President and CEO of MELA Sciences.
The new business plan refocuses the Company’s go-to-market strategy on medical dermatologists who treat high-risk patients and on Key Opinion Leaders at leading hospitals and teaching institutions in the United States as they lead the charge on melanoma.
The new business model allows dermatologists to purchase the MelaFind® device rather than rent it. This is typically how business is conducted for medical devices.
The Company is also working diligently on securing insurance reimbursement codes for both doctors and insurance companies.
Since the end of 2013, the Company has also taken important steps in raising awareness of, the Company and its product MelaFind®, and strengthening its balance sheet. Senior management presented at a small-cap investor conference in New York and was well received. MelaFind® has been introduced to several major institutions in the United States gaining placement in four of the leading melanoma centers.
In February, the Company completed a private placement offering with two major healthcare institutional investors and its directors for net proceeds of approximately $11.54 million prior to approximately $2.5 million in penalties that have applied and up to an additional $1.4 million in penalties that may apply. As part of the offering the Company sold shares of its non-redeemable preferred stock, which is convertible into approximately 14.6 million shares of its common stock and warrants to purchase up to 13.3 million shares of common stock which, if exercised, could result in proceeds to the Company of up to $9.8 million. In addition, the Company sold approximately 200,000 shares of its common stock to its directors.
About MELA Sciences, Inc. www.melasciences.com
MELA Sciences is a medical device company developing dermatology diagnostics utilizing state-of-the-art optical imaging. The flagship product is MelaFind®, an FDA, PMA and CE Mark approved, non-invasive diagnostic tool to assist dermatologists in melanoma evaluation and diagnosis. MelaFind® uses a variety of visible to near-infrared light waves to analyze atypical pigmented skin lesions 2.5mm below the skin surface. It provides images and data on the relative disorganization of a lesion's structure that provides substantial additional perspective to assist melanoma diagnosis. MELA is also exploring new potential uses for its core imaging technology and algorithms.
This press release includes "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995. These statements include but are not limited to our plans, objectives, expectations and intentions and may contain words such as “seeks,” “look forward,” and “there seems” that suggest future events or trends. These statements are based on our current expectations and are inherently subject to significant uncertainties and changes in circumstances. Actual results may differ materially from our expectations due to financial, economic, business, competitive, market, regulatory and political factors or conditions affecting the company and the medical device industry in general, as well as more specific risks and uncertainties set forth in the company’s SEC reports on Forms 10-Q and 10-K. Given such uncertainties, any or all of these forward-looking statements may prove to be incorrect or unreliable. MELA Sciences assumes no duty to update its forward-looking statements and urges investors to carefully review its SEC disclosures available at www.sec.gov and www.melasciences.com.
|MELA SCIENCES, INC.|
|As of December 31, 2013 and 2012|
|(in thousands, except for share and per share data)|
|Cash and cash equivalents||$||3,783||$||7,862|
|Accounts receivable, net||57||180|
|Prepaid expenses and other current assets||880||965|
|Total Current Assets||10,351||9,683|
|Property and equipment, net||3,691||7,350|
|Patents and trademarks, net||42||47|
|Deferred financing costs||-||106|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Deferred placement revenue||244||172|
|Other current liabilities||68||41|
|Total Current Liabilities||5,652||3,019|
|Long Term Liabilities:|
|Deferred placement revenue||64||132|
|Total Long Term Liabilities||184||276|
|COMMITMENTS AND CONTINGENCIES|
|Preferred stock - $.10 par value; authorized 10,000,000 shares: issued and outstanding: none|
|Common stock - $.001 par value; authorized 95,000,000 shares:|
Issued and outstanding 47,501,596 and 32,204,720 shares at December 31, 2013 and 2012, respectively.
|Additional paid-in capital||176,396||156,143|
|Total Liabilities and Stockholders' Equity||$||14,132||$||17,270|
|MELA SCIENCES, INC.|
|STATEMENTS OF OPERATIONS|
|(in thousands, except for share and per share data)|
|Three months ended December 31||Twelve months ended December 31|
|Cost of revenue||914||971||4,341||2,042|
|Research and development||540||1,285||3,782||6,792|
|Selling, general and administrative||3,096||3,953||15,536||14,169|
|Impairment of long-lived assets||-||-||1,011||-|
|Total operating expenses||3,636||5,238||20,329||20,961|
|Other income (expenses):|
|Change in fair value of warrant liability||(206||)||-||(296||)||-|
|Loss on early extinguishment of debt||-||-||(983||)||-|
|Other income, net||6||5||21||20|
|Basic and diluted net loss per common share||$||(0.09||)||$||(0.19||)||$||(0.60||)||$||(0.74||)|
Basic and diluted weighted average number of common shares outstanding
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo in Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal an...
May. 24, 2015 03:00 AM EDT Reads: 2,747
DevOps tends to focus on the relationship between Dev and Ops, putting an emphasis on the ops and application infrastructure. But that’s changing with microservices architectures. In her session at DevOps Summit, Lori MacVittie, Evangelist for F5 Networks, will focus on how microservices are changing the underlying architectures needed to scale, secure and deliver applications based on highly distributed (micro) services and why that means an expansion into “the network” for DevOps.
May. 24, 2015 03:00 AM EDT Reads: 2,924
How do APIs and IoT relate? The answer is not as simple as merely adding an API on top of a dumb device, but rather about understanding the architectural patterns for implementing an IoT fabric. There are typically two or three trends: Exposing the device to a management framework Exposing that management framework to a business centric logic Exposing that business layer and data to end users. This last trend is the IoT stack, which involves a new shift in the separation of what stuff happens, where data lives and where the interface lies. For instance, it's a mix of architectural styles ...
May. 24, 2015 03:00 AM EDT Reads: 5,700
The 3rd International @ThingsExpo, co-located with the 16th International Cloud Expo – to be held June 9-11, 2015, at the Javits Center in New York City, NY – is now accepting Hackathon proposals. Hackathon sponsorship benefits include general brand exposure and increasing engagement with the developer ecosystem. At Cloud Expo 2014 Silicon Valley, IBM held the Bluemix Developer Playground on November 5 and ElasticBox held the DevOps Hackathon on November 6. Both events took place on the expo floor. The Bluemix Developer Playground, for developers of all levels, highlighted the ease of use of...
May. 24, 2015 02:30 AM EDT Reads: 4,339
We’re no longer looking to the future for the IoT wave. It’s no longer a distant dream but a reality that has arrived. It’s now time to make sure the industry is in alignment to meet the IoT growing pains – cooperate and collaborate as well as innovate. In his session at @ThingsExpo, Jim Hunter, Chief Scientist & Technology Evangelist at Greenwave Systems, will examine the key ingredients to IoT success and identify solutions to challenges the industry is facing. The deep industry expertise behind this presentation will provide attendees with a leading edge view of rapidly emerging IoT oppor...
May. 24, 2015 02:30 AM EDT Reads: 4,981
Connected devices and the Internet of Things are getting significant momentum in 2014. In his session at Internet of @ThingsExpo, Jim Hunter, Chief Scientist & Technology Evangelist at Greenwave Systems, examined three key elements that together will drive mass adoption of the IoT before the end of 2015. The first element is the recent advent of robust open source protocols (like AllJoyn and WebRTC) that facilitate M2M communication. The second is broad availability of flexible, cost-effective storage designed to handle the massive surge in back-end data in a world where timely analytics is e...
May. 24, 2015 02:00 AM EDT Reads: 6,189
We certainly live in interesting technological times. And no more interesting than the current competing IoT standards for connectivity. Various standards bodies, approaches, and ecosystems are vying for mindshare and positioning for a competitive edge. It is clear that when the dust settles, we will have new protocols, evolved protocols, that will change the way we interact with devices and infrastructure. We will also have evolved web protocols, like HTTP/2, that will be changing the very core of our infrastructures. At the same time, we have old approaches made new again like micro-services...
May. 24, 2015 01:30 AM EDT Reads: 5,350
SYS-CON Events announced today that Gridstore™, the leader in hyper-converged infrastructure purpose-built to optimize Microsoft workloads, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Gridstore™ is the leader in hyper-converged infrastructure purpose-built for Microsoft workloads and designed to accelerate applications in virtualized environments. Gridstore’s hyper-converged infrastructure is the industry’s first all flash version of HyperConverged Appliances that include both compute and storag...
May. 24, 2015 01:15 AM EDT Reads: 6,207
For years, we’ve relied too heavily on individual network functions or simplistic cloud controllers. However, they are no longer enough for today’s modern cloud data center. Businesses need a comprehensive platform architecture in order to deliver a complete networking suite for IoT environment based on OpenStack. In his session at @ThingsExpo, Dhiraj Sehgal from PLUMgrid will discuss what a holistic networking solution should really entail, and how to build a complete platform that is scalable, secure, agile and automated.
May. 24, 2015 01:00 AM EDT Reads: 4,332
The industrial software market has treated data with the mentality of “collect everything now, worry about how to use it later.” We now find ourselves buried in data, with the pervasive connectivity of the (Industrial) Internet of Things only piling on more numbers. There’s too much data and not enough information. In his session at @ThingsExpo, Bob Gates, Global Marketing Director, GE’s Intelligent Platforms business, to discuss how realizing the power of IoT, software developers are now focused on understanding how industrial data can create intelligence for industrial operations. Imagine ...
May. 24, 2015 01:00 AM EDT Reads: 5,242
Hadoop as a Service (as offered by handful of niche vendors now) is a cloud computing solution that makes medium and large-scale data processing accessible, easy, fast and inexpensive. In his session at Big Data Expo, Kumar Ramamurthy, Vice President and Chief Technologist, EIM & Big Data, at Virtusa, will discuss how this is achieved by eliminating the operational challenges of running Hadoop, so one can focus on business growth. The fragmented Hadoop distribution world and various PaaS solutions that provide a Hadoop flavor either make choices for customers very flexible in the name of opti...
May. 24, 2015 12:30 AM EDT Reads: 3,862
In the consumer IoT, everything is new, and the IT world of bits and bytes holds sway. But industrial and commercial realms encompass operational technology (OT) that has been around for 25 or 50 years. This grittier, pre-IP, more hands-on world has much to gain from Industrial IoT (IIoT) applications and principles. But adding sensors and wireless connectivity won’t work in environments that demand unwavering reliability and performance. In his session at @ThingsExpo, Ron Sege, CEO of Echelon, will discuss how as enterprise IT embraces other IoT-related technology trends, enterprises with i...
May. 24, 2015 12:00 AM EDT Reads: 4,334
Wearable devices have come of age. The primary applications of wearables so far have been "the Quantified Self" or the tracking of one's fitness and health status. We propose the evolution of wearables into social and emotional communication devices. Our BE(tm) sensor uses light to visualize the skin conductance response. Our sensors are very inexpensive and can be massively distributed to audiences or groups of any size, in order to gauge reactions to performances, video, or any kind of presentation. In her session at @ThingsExpo, Jocelyn Scheirer, CEO & Founder of Bionolux, will discuss ho...
May. 23, 2015 09:00 PM EDT Reads: 5,212
The true value of the Internet of Things (IoT) lies not just in the data, but through the services that protect the data, perform the analysis and present findings in a usable way. With many IoT elements rooted in traditional IT components, Big Data and IoT isn’t just a play for enterprise. In fact, the IoT presents SMBs with the prospect of launching entirely new activities and exploring innovative areas. CompTIA research identifies several areas where IoT is expected to have the greatest impact.
May. 23, 2015 09:00 PM EDT Reads: 4,852
Every day we read jaw-dropping stats on the explosion of data. We allocate significant resources to harness and better understand it. We build businesses around it. But we’ve only just begun. For big payoffs in Big Data, CIOs are turning to cognitive computing. Cognitive computing’s ability to securely extract insights, understand natural language, and get smarter each time it’s used is the next, logical step for Big Data.
May. 23, 2015 08:00 PM EDT Reads: 2,144
We are reaching the end of the beginning with WebRTC, and real systems using this technology have begun to appear. One challenge that faces every WebRTC deployment (in some form or another) is identity management. For example, if you have an existing service – possibly built on a variety of different PaaS/SaaS offerings – and you want to add real-time communications you are faced with a challenge relating to user management, authentication, authorization, and validation. Service providers will want to use their existing identities, but these will have credentials already that are (hopefully) i...
May. 23, 2015 07:00 PM EDT Reads: 4,295
The 4th International Internet of @ThingsExpo, co-located with the 17th International Cloud Expo - to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA - announces that its Call for Papers is open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
May. 23, 2015 07:00 PM EDT Reads: 1,762
17th Cloud Expo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterprises are using some form of XaaS – software, platform, and infrastructure as a service.
May. 23, 2015 05:00 PM EDT Reads: 2,468
The Industrial Internet revolution is now underway, enabled by connected machines and billions of devices that communicate and collaborate. The massive amounts of Big Data requiring real-time analysis is flooding legacy IT systems and giving way to cloud environments that can handle the unpredictable workloads. Yet many barriers remain until we can fully realize the opportunities and benefits from the convergence of machines and devices with Big Data and the cloud, including interoperability, data security and privacy.
May. 23, 2015 04:00 PM EDT Reads: 4,799
The Internet of Things is tied together with a thin strand that is known as time. Coincidentally, at the core of nearly all data analytics is a timestamp. When working with time series data there are a few core principles that everyone should consider, especially across datasets where time is the common boundary. In his session at Internet of @ThingsExpo, Jim Scott, Director of Enterprise Strategy & Architecture at MapR Technologies, discussed single-value, geo-spatial, and log time series data. By focusing on enterprise applications and the data center, he will use OpenTSDB as an example t...
May. 23, 2015 02:00 PM EDT Reads: 6,437