Welcome!

News Feed Item

MYOS Corporation Reports 2014 First Quarter Results

CEDAR KNOLLS, NJ -- (Marketwired) -- 05/16/14 -- MYOS Corporation (OTCBB: MYOS)

  • Company Well Positioned to Achieve Significant Near-Term Milestones by Year End
  • Research and Development Programs Exploring Fortetropin™ as Potential Treatment Option in Muscle Health and Sarcopenia Progressing in Multiple Clinical Studies

MYOS Corporation (OTCBB: MYOS), an emerging biotherapeutics and bionutrition company focused on the discovery, development and commercialization of products that improve human muscle health and performance ("MYOS" or the "Company"), announced today its financial results for the first quarter ended March 31, 2014 and provided highlights of the Company's recent progress and anticipated near-term research and development milestones for Fortetropin™ (also known as MYO-T12®), the first clinically proven natural myostatin inhibitor.

"Since the commercial launch of our first Fortetropin-powered bionutrition product, MYO-X™, the Company has successfully created a solid growth and revenue engine, with total net revenues since inception approaching $6 million. We see our growing bionutrition revenues as an important means of accelerating investment in research and development. The Company is leveraging the expertise developed in advancing its bionutrition business to build a biotherapeutics portfolio of small molecules and other compounds which can be applied to the increasingly important clinical conditions in muscle health," said Robert J. Hariri, M.D., Ph.D., Chairman of the Board of MYOS. "During the first quarter we enhanced our commitment to our clinical research by strengthening our management team with a highly experienced Chief Medical Officer. We also initiated two additional clinical studies to further evaluate the effects of Fortetropin on myostatin inhibition in an effort to explore potential opportunities for expansion of our age-management pipeline. We believe that our team's continued dedication to our emerging muscle health therapeutic development program will enable MYOS to provide innovative solutions for multiple potential indications including sarcopenia, cachexia and age-associated muscle loss treatments in age-management."

FIRST QUARTER AND RECENT HIGHLIGHTS

  • Reported first quarter 2014 net revenues of $1.55 million, an increase of 457% compared to the first quarter of 2013;
  • Initiated a clinical study on Fortetropin's effect on skeletal muscle mass and strength in resistance-trained male subjects;
  • Sponsored the upcoming Cancer Cachexia 2014 conference highlighting evolving mechanisms and therapies for treating debilitating muscle wasting syndrome related to cancer;
  • Partnered with the Muscular Dystrophy Association (MDA) to raise funds and awareness for MDA's fight against degenerative muscle disease;
  • Launched an educational portal on sarcopenia (www.sarcopeniacure.com) in conjunction with the Aging in Motion awareness campaign working to develop measures of clinical benefit for therapeutic products to treat sarcopenia;
  • Presented lipidomic and proteomic characterization data on Fortetropin at the 2014 International Conference on Frailty and Sarcopenia Research and published an abstract in Journal of Frailty and Aging providing new insights into mechanisms by which Fortetropin may exert its beneficial effects on muscle;
  • Initiated a clinical study on the effects of Fortetropin on blood chemistry, body mass index, waist circumference and other indices of muscle health in adult women;
  • Appointed Wall Street investment veteran, Christopher Pechock, to the Board of Directors;
  • Appointed experienced healthcare industry leader and clinician, Robert C. Ashton, Jr., M.D., as Chief Medical Officer; and
  • Closed $4.735 million in private equity financing followed by a 1-for-50 reverse stock split.

NEAR-TERM MILESTONES

  • Clinical study data on Fortetropin in muscle and strength building activity in resistance-trained men expected by the end of the second quarter of 2014;
  • Results of Fortetropin study in adult women expected early in the fourth quarter of 2014;
  • Anticipate strategic collaboration for Fortetropin in age management market;
  • Pre-clinical data on synergistic effects of myostatin inhibition on testosterone-mediated muscle growth expected in the second half of 2014;
  • Formulation of liquid bionutrition Fortetropin product targeted for year-end; and
  • Expansion of Board of Directors and Scientific Advisory Board anticipated to begin this year.

Peter Levy, MYOS' President and Chief Operating Officer added, "For the remainder of 2014 the MYOS team will be laser-focused on advancing our clinical pipeline and expanding Fortetropin in the age-management market and for additional therapeutic opportunities. The Company's patent strategy is sound and we will continue to rigorously pursue additional enhancements to our IP portfolio. By the end of the year we expect to have data from three studies, which we believe will be key to transforming the Company into its next phase of growth as a biotherapeutic leader in age-management and muscle health. We believe MYOS is well-positioned to capitalize on the strategic and commercial prospects for Foretropin and represents an opportunity for a broad group of investors attracted to small-to-mid cap companies interested in maximizing shareholder return."

FIRST QUARTER 2014 FINANCIAL SUMMARY

For the first quarter of 2014, the Company's net revenues were approximately $1,546,000 compared to net revenues of approximately $277,000 for the first quarter of 2013 and approximately $1,408,000 for the fourth quarter of 2013. Net revenues for the trailing twelve months was approximately $4,587,000.

Loss from operations was approximately $423,000 for the first quarter of 2014 compared to approximately $1,092,000 for the first quarter of 2013 and approximately $1,409,000 for the fourth quarter of 2013. Operating losses include the Company's investment in research and development activities in the first quarter of 2014 of approximately $434,000 compared to approximately $178,000 in the first quarter of 2013 and approximately $356,000 in the fourth quarter of 2013.

Net loss for the first quarter of 2014 was approximately $422,000 compared to approximately $1,090,000 for the first quarter of 2013 and approximately $1,408,000 for the fourth quarter of 2013. Basic and diluted net loss per share was $(0.16) for the first quarter of 2014 compared to $(0.47) for the first quarter of 2013 and $(0.64) for the fourth quarter of 2013. Per share results are based on weighted average shares outstanding of 2.703 million for the first quarter of 2014 compared to 2.295 million for the first quarter of 2013 and 2.217 million for the fourth quarter of 2013.

On a non-GAAP basis, net loss for the first quarter of 2014 was approximately $119,000 compared to approximately $736,000 for the first quarter of 2013. Non-GAAP basic and diluted net loss per share was $(0.04) for the first quarter of 2014 compared to $(0.32) for the first quarter of 2013. Non-GAAP net loss excludes stock-based compensation of approximately $303,000 for the first quarter of 2014 compared to approximately $354,000 for the first quarter of 2013.

The Company had cash of approximately $3,914,000 and total assets of $8,964,000 as of March 31, 2014 compared to cash of approximately $451,000 and total assets of $3,836,000 as of December 31, 2013.

In addition to the GAAP financial measures set forth in this press release, the Company has included non-GAAP net loss and non-GAAP basic and diluted net loss per share measures, which present results on a basis adjusted for certain items. Non-GAAP net loss and non-GAAP basic and diluted net loss per share are supplemental measures of our performance that are not required by, or presented in accordance with, GAAP. The Company uses these non-GAAP measures as key performance measures for the purpose of evaluating performance internally. The Company also believes these non-GAAP measures provide the Company's investors with useful information regarding the Company's historical operating results. These non-GAAP measures are not intended to replace the presentation of the Company's financial results in accordance with GAAP. Use of the terms non-GAAP net loss, and non-GAAP basic and diluted net loss per share may differ from similar measures reported by other companies. We define non-GAAP net loss as net loss adjusted for stock-based compensation and certain special charges that are otherwise included in GAAP net loss, including changes in fair value of warrants, amortization of deferred financing costs and impairment charges. Non-GAAP basic and diluted net loss per share refers to non-GAAP net loss divided by the weighted average number of basic and diluted shares outstanding. All of the non-GAAP measures discussed above are reconciled from their respective GAAP measures in the attached table "Reconciliation of GAAP to non-GAAP Net Loss" table set forth below.

A summary of key financial highlights for the three months ended March 31, 2014 and 2013 is as follows:


                      MYOS CORPORATION AND SUBSIDIARY
                       (a development stage company)
                   CONSOLIDATED STATEMENTS OF OPERATIONS
                                (Unaudited)
                                                                April 11,
                                                                   2007
                                                                (Inception
                                                                  Date)
                                Three Months Ended March 31,   to March 31,
                                     2014           2013           2014
                                -------------  -------------  -------------
Net revenue                     $   1,546,334  $     277,374  $   5,875,421
Cost of sales                         404,774        126,989      2,838,896
                                -------------  -------------  -------------
  Gross profit                      1,141,560        150,385      3,036,525
Operating expenses                  1,564,638      1,242,444     15,504,721
                                -------------  -------------  -------------
  Loss from operations               (423,078)    (1,092,059)   (12,468,196)

  Other Income (Expense)
  Interest income                       1,189          1,865         14,068
  Interest expense                        (14)             -       (827,044)
  Value of warrants in excess of
   the amount of additional
   paid-in capital received in
   the related private placement
   of restricted common stock               -              -     (2,405,303)
    Change in fair value of
     warrants                               -              -      4,085,570
    Impairment charge -
     intellectual property                  -              -     (2,662,000)
    Amortization of deferred
     financing costs                        -              -        (80,000)
    Gain on forgiveness of debt             -              -         12,500
                                -------------  -------------  -------------
Total other income (expense)            1,175          1,865     (1,862,209)
                                -------------  -------------  -------------

Net loss                             (421,903)    (1,090,194)   (14,330,405)
                                =============  =============  =============

Weighted average number of
 common shares outstanding,
 basic and diluted                  2,703,341      2,295,349

Basic and diluted net loss per
 share attributable to common
 stockholders                   $       (0.16) $       (0.47)
                                =============  =============



                      MYOS CORPORATION AND SUBSIDIARY
                       (a development stage company)
                        CONSOLIDATED BALANCE SHEETS

                                                   March 31,   December 31,
                                                     2014          2013
                                                 ------------  ------------
                                                  (Unaudited)
ASSETS
Current assets
Cash                                             $  3,913,705  $    451,361
Accounts receivable                                 1,494,879       644,760
Inventories                                           860,572       142,430
Prepaid expenses and other current assets             319,580       215,128
                                                 ------------  ------------
Total current assets                                6,588,736     1,453,679
Fixed assets, net of accumulated depreciation         336,398       344,366
Intellectual property                               2,000,000     2,000,000
Intangible assets                                      38,652        38,377
                                                 ------------  ------------
Total assets                                     $  8,963,786  $  3,836,422
                                                 ============  ============

LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable                                 $    710,210  $    184,685
Accrued expenses                                      369,578       311,704
                                                 ------------  ------------
Total current liabilities                           1,079,788       496,389
                                                 ------------  ------------

Total liabilities                                   1,079,788       496,389
                                                 ------------  ------------

Commitments and contingencies

Stockholders' equity
Preferred stock, $.001 par value; 500,000 shares
 authorized; no shares issued and outstanding               -             -
Common stock, $.001 par value, 6,000,000 shares
 authorized; 2,919,235 and 2,227,447 shares
 issued and outstanding at March 31, 2014 and
 December 31, 2013, respectively                        2,918         2,227
Additional paid-in capital                         22,211,485    17,246,308
Deficit accumulated during development stage      (14,330,405)  (13,908,502)
                                                 ------------  ------------
Total stockholders' equity                          7,883,998     3,340,033
                                                 ------------  ------------

Total liabilities and stockholders' equity       $  8,963,786  $  3,836,422
                                                 ============  ============



                      MYOS CORPORATION AND SUBSIDIARY
                       (a development stage company)
                Reconciliation of GAAP to Non-GAAP Net Loss
                                (Unaudited)
                                                                 April 11,
                                                                   2007
                                                                (Inception
                                                                   Date)
                                 Three Months Ended March 31,  to March 31,
                                      2014           2013          2014
                                 -------------  -------------  ------------
GAAP - net loss                       (421,903)    (1,090,194)  (14,330,405)

Stock-based compensation               302,911        354,372     4,985,132
Change in fair value of warrants             -              -    (4,085,570)
Amortization of deferred
 financing costs                             -              -        80,000
Impairment charges                           -              -     2,662,000

                                 -------------  -------------  ------------
Non-GAAP - net loss                   (118,992)      (735,822)  (10,688,843)
                                 -------------  -------------  ------------

Weighted average number of common
 shares outstanding, basic and
 diluted                             2,703,341      2,295,349

GAAP basic and diluted net loss
 per share                       $       (0.16) $       (0.47)

Non-GAAP basic and diluted net
 loss per share                  $       (0.04) $       (0.32)

About MYOS Corporation
MYOS is a developmental stage bionutrition and biotherapeutics company focused on the discovery, development and commercialization of products that improve muscle health and function essential to the management of sarcopenia, cachexia and degenerative muscle diseases. MYOS is the owner of Fortetropin™ (also known as MYO-T12®), the first clinically proven natural myostatin inhibitor. Myostatin is a natural regulatory protein, which inhibits muscle growth and recovery. Medical literature suggests that lowering myostatin levels has many potential health benefits including increased muscle mass, healthy weight management, improved energy levels, stimulation of muscle healing as well as treating sarcopenia, a condition of age-related loss of muscle mass. For more information on MYO-T12 and to discover why MYOS is known as "The Muscle Company,"™ visit www.myoscorp.com.

The Company's first commercial product MYO-X™, powered by MYO-T12®, is distributed by Maximum Human Performance (MHP) and is currently available on popular retailer websites including www.mhpstrong.com, www.bodybuilding.com, www.amazon.com and in specialty retailers including GNC and Vitamin Shoppe and others. MYOS believes that MYO-X, as well as future products it envisions, will redefine existing standards for muscle health.

Forward-Looking Statements
Any statements in this release that are not historical facts are forward-looking statements. Actual results may differ materially from those projected or implied in any forward-looking statements. Such statements involve risks and uncertainties, including but not limited to those relating to the successful continued research of MYO-T12® and its effects on myostatin inhibition, including our research and development activities including the clinical studies described herein, product and customer demand, the continued growth of repeat purchases, market acceptance of our existing and future products, the ability to create new products through research and development, the continued growth in market expansion and revenue including the expansion into the age management market, the successful entry into new markets including the age management market, the ability to attract additional investors and increase shareholder value, the ability to generate the forecasted revenue stream and cash flow from sales of Fortetropin™ and MYO-X™, the ability to achieve a sustainable profitable business, the effect of economic conditions, the ability to protect our intellectual property rights, the continued growth and expansion of MYO-X in GNC, Vitamin Shoppe and other specialty retail stores, the ability to strengthen our manufacturing relationships and reduce the costs of our products, competition from other providers and products, risks in product development, our ability to raise capital to fund continuing operations, and other factors discussed from time to time in our Securities and Exchange Commission filings. We undertake no obligation to update or revise any forward-looking statement for events or circumstances after the date on which such statement is made except as required by law.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Investor and Media Contact:
Jenene Thomas
Investor Relations and Corporate Communications
(973) 509-0444
Email Contact

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
One of the biggest challenges with adopting a DevOps mentality is: new applications are easily adapted to cloud-native, microservice-based, or containerized architectures - they can be built for them - but old applications need complex refactoring. On the other hand, these new technologies can require relearning or adapting new, oftentimes more complex, methodologies and tools to be ready for production. In his general session at @DevOpsSummit at 20th Cloud Expo, Chris Brown, Solutions Marketi...
While some vendors scramble to create and sell you a fancy solution for monitoring your spanking new Amazon Lambdas, hear how you can do it on the cheap using just built-in Java APIs yourself. By exploiting a little-known fact that Lambdas aren’t exactly single threaded, you can effectively identify hot spots in your serverless code. In his session at 20th Cloud Expo, David Martin, Principal Product Owner at CA Technologies, will give a live demonstration and code walkthrough, showing how to ov...
Existing Big Data solutions are mainly focused on the discovery and analysis of data. The solutions are scalable and highly available but tedious when swapping in and swapping out occurs in disarray and thrashing takes place. The resolution for thrashing through machine learning algorithms and support nomenclature is through simple techniques. Organizations that have been collecting large customer data are increasingly seeing the need to use the data for swapping in and out and thrashing occurs ...
We all know that end users experience the internet primarily with mobile devices. From an app development perspective, we know that successfully responding to the needs of mobile customers depends on rapid DevOps – failing fast, in short, until the right solution evolves in your customers' relationship to your business. Whether you’re decomposing an SOA monolith, or developing a new application cloud natively, it’s not a question of using microservices - not doing so will be a path to eventual ...
Detecting internal user threats in the Big Data eco-system is challenging and cumbersome. Many organizations monitor internal usage of the Big Data eco-system using a set of alerts. This is not a scalable process given the increase in the number of alerts with the accelerating growth in data volume and user base. Organizations are increasingly leveraging machine learning to monitor only those data elements that are sensitive and critical, autonomously establish monitoring policies, and to detect...
DevOps at Cloud Expo – being held October 31 - November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises – and delivering real r...
As enterprise cloud becomes the norm, businesses and government programs must address compounded regulatory compliance related to data privacy and information protection. The most recent, Controlled Unclassified Information and the EU’s GDPR have board level implications and companies still struggle with demonstrating due diligence. Developers and DevOps leaders, as part of the pre-planning process and the associated supply chain, could benefit from updating their code libraries and design by in...
SYS-CON Events announced today that CollabNet, a global leader in enterprise software development, release automation and DevOps solutions, will be a Bronze Sponsor of SYS-CON's 20th International Cloud Expo®, taking place from June 6-8, 2017, at the Javits Center in New York City, NY. CollabNet offers a broad range of solutions with the mission of helping modern organizations deliver quality software at speed. The company’s latest innovation, the DevOps Lifecycle Manager (DLM), supports Value S...
SYS-CON Events announced today that A&I Solutions named "Bronze Sponsor" of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Founded over 15 years ago in 1999, A&I Solutions continues to provide companies with premier integrated enterprise solutions. By partnering with the trusted and proven solutions of leading technology companies, our customers are assured high performance levels across all IT environments including:...
SYS-CON Events announced today that Progress, a global leader in application development, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Enterprises today are rapidly adopting the cloud, while continuing to retain business-critical/sensitive data inside the firewall. This is creating two separate data silos – one inside the firewall and the other outside the firewall. Cloud ISVs ofte...
When NSA's digital armory was leaked, it was only a matter of time before the code was morphed into a ransom seeking worm. This talk, designed for C-level attendees, demonstrates a Live Hack of a virtual environment to show the ease in which any average user can leverage these tools and infiltrate their network environment. This session will include an overview of the Shadbrokers NSA leak situation.
While presenting own advanced Robo-Advisory Platform, Michał Różański, Managing Partner at EARP and CEO at Empirica, will illustrate the most important issues of building tailored FinTech software in his session at 20th Cloud Expo. He will share experiences we have gained for over 6 years of developing solutions for financial institutions and FinTech companies, including robo-advisors. We welcome all FinTech innovators interested in how properly implemented technology can move their businesses f...
SYS-CON Events announced today that Loom Systems will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Founded in 2015, Loom Systems delivers an advanced AI solution to predict and prevent problems in the digital business. Loom stands alone in the industry as an AI analysis platform requiring no prior math knowledge from operators, leveraging the existing staff to succeed in the digital era. With offices in S...
SYS-CON Events announced today that Enzu will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Enzu’s mission is to be the leading provider of enterprise cloud solutions worldwide. Enzu enables online businesses to use its IT infrastructure to their competitive ad...
Apache OpenWhisk on IBM Bluemix provides a powerful and flexible environment for deploying cloud-native applications driven by data, message, and API call events. In his session at 20th Cloud Expo, Daniel Krook, Software Architect, IBM Watson and Cloud Platform, and Distinguished IT Specialist, will discuss why serverless architectures are attractive for many emerging cloud workloads and when you should consider OpenWhisk for your next project. Then get started on Bluemix with three sample appl...