UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended: December 31, 2016
Or
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission File No. 000-53298
MYOS RENS TECHNOLOGY INC.
(Exact name of small business issuer as specified in its charter)
Nevada
(State or other jurisdiction of
incorporation or organization)
90-0772394
(I.R.S. Employer
Identification No.)
45 Horsehill Road, Suite 106
Cedar Knolls, New Jersey 07927
(Address of Principal Executive Offices)
(973) 509-0444
(Issuer’s telephone number)
Securities registered under Section 12(b) of the Exchange Act:
Common Stock, $0.001 par value
Series A Preferred Stock Purchase Rights, $0.001 par value
(Title of class)
Securities registered under Section 12(g) of the Exchange Act:
None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act
during the past 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive
Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12
months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒ No ☐
Indicate by check mark if disclosure of delinquent filers in response to Item 405 of Regulation S-K is not contained herein, and will not be
contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this
Form 10-K or any amendment to this Form 10-K. ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting
company. See definition of “large accelerated filer”, “accelerated filer”, and “small reporting company” in Rule 12b-2 of the Exchange Act.
(check one)
Large accelerated filer ☐
Accelerated filer ☐
Non-accelerated filer ☐
Smaller reporting company ☒
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The aggregate market value of the outstanding common stock, other than shares held by persons who may be deemed affiliates of the
registrant, computed by reference to the closing sales price of the registrant’s common shares on June 30, 2016, as reported on the Nasdaq
Capital Market, was approximately $9.9 million.
As of March 30, 2017, there were 5,844,372 shares of the registrant’s common stock outstanding.
TABLE OF CONTENTS
Business.
Risk Factors.
Unresolved Staff Comments.
Properties.
Legal Proceedings.
Mine Safety Disclosures.
Market for Registrant’s Common Equity and Related Stockholder Matters and Issuer Purchases of Equity Securities.
Selected Financial Data.
Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Quantitative and Qualitative Disclosures About Market Risk.
Financial Statements and Supplemental Data.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
Controls and Procedures.
Other Information.
Directors and Executive Officers and Corporate Governance.
Executive Compensation.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
Certain Relationships and Related Transactions and Director Independence.
Principal Account Fees and Services.
PART I
Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.
PART II
Item 5.
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
PART III
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
PART IV
Item 15.
Item 16.
Exhibits and Financial Statement Schedules.
Form 10-K Summary
Signatures
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CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
This report includes certain “forward-looking statements” relating to such matters as anticipated financial performance, future
revenues or earnings, business prospects, projected ventures, new products and services, anticipated market performance and similar
matters. The words “may,” “will,” expect,” anticipate,” “continue,” “estimate,” “project,” “intend,” and similar expressions are intended to
identify forward-looking statements regarding events, conditions, and financial trends that may affect future plans of operations, business
strategy, operating results, and financial position.
We caution readers that a variety of factors could cause actual results to differ materially from anticipated results or other matters
expressed in forward-looking statements. These risks and uncertainties, many of which are beyond our control, include:
● our ability to market and generate sales of our products, including Fortetropin®, Qurr, Egg Yolk Powder Drink, Physician’s
Muscle Heath, Rē Muscle HealthTM and other products;
● our ability to successfully expand into new market categories, as well as geographic markets (including expansion in China and
Southeast Asia markets;
● our ability to adequately protect our intellectual property;
● our ability to develop and introduce new products and mitigate competitive threats from other providers and products;
● our ability to generate future sales and achieve profitability;
● our ability to attract and retain key members of our management team;
● our ability to collect our accounts receivable from our customers;
● our reliance on third-party processors;
● our ability to maintain and expand our manufacturing capabilities and reduce the cost of our products;
● shortages in the supply of, or increases in the prices of, raw materials or shelf life limits on ingredients or finished product;
● our ability to conduct research and development activities and the success of such activities to create new products and further
validate our existing ones, including continued research of Fortetropin and its effects on myostatin levels, inflammatory cytokine
levels and cholesterol levels;
● our ability to maintain raw material importation permits, obtain governmental approvals and comply with governmental regulations;
● future financing plans;
● our ability to attract additional investors, increase shareholder value and continue to comply with NASDAQ’s continuing listing
standards;
● anticipated needs for working capital;
● anticipated trends in our industry;
● the effect of economic conditions; and
● competition existing today or that will likely arise in the future.
Although management believes the expectations reflected in these forward-looking statements are reasonable, such expectations
cannot guarantee future results, levels of activity, performance or achievements.
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Item 1.
Business.
Overview
PART I
We are an emerging 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,
and as an adjunct to the treatment of obesity. As used in this report, the “Company”, “MYOS”, “our”, or “we” refers to MYOS RENS
Technology Inc. and its wholly-owned subsidiary, unless the context indicates otherwise.
We were incorporated under the laws of the State of Nevada on April 11, 2007. On March 17, 2016, we merged with our wholly-
owned subsidiary and changed our name from MYOS Corporation to MYOS RENS Technology Inc. Prior to February 2011, we did not
have any operations and did not generate revenues. In February 2011, we entered into an intellectual property purchase agreement pursuant
to which our subsidiary purchased from Peak Wellness, Inc., or Peak, the intellectual property pertaining to Fortetropin ®, a dietary
supplement that has been shown in clinical studies to temporarily decrease the levels of serum myostatin, MYO-T12, a proprietary
formulation containing Fortetropin, certain trademarks, trade secrets, patent applications and certain domain names.
Since February 2011, our principal business activities have been to: (i) deepen our scientific understanding of the activity of
Fortetropin, which refers to a proprietary proteo-lipid composite derived from fertilized eggs of specific chicken species processed using a
patented methodology which preserves the bioactivity of the constituent proteins and lipids, specifically as a natural, reversible, temporary
reducing agent of myostatin, and to leverage this knowledge to strengthen and build our intellectual property; (ii) conduct research and
development activities to evaluate myostatin modulation in a range of both wellness and disease states; (iii) identify other products and
technologies which may broaden our portfolio and define a business development strategy to protect, enhance and accelerate the growth of
our products; (iv) reduce the cost of manufacturing through process improvement; (v) identify contract manufacturing resources that can
fully meet our future growth requirements; (vi) develop a differentiated and advantaged consumer positioning, brand name and
iconography; and, (vii) create sales and marketing capabilities to maximize near-term and future revenues. We believe that existing
wellness and therapeutic targets, such as myostatin, represent a rational entry point for additional drug discovery efforts and are evaluating
a separate, concurrent objective in this area.
Our executive offices are currently located at 45 Horsehill Road, Suite 106, Cedar Knolls, New Jersey 07927 and our telephone
number is (973) 509-0444. Our corporate website address is http://www.myosrens.com and our new muscle health education and product
website is http://www.qurr.com. Neither the information on our current or future website is, nor shall such information be deemed to be, a
part of this report or incorporated in filings we make with the Securities and Exchange Commission.
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General
Following our purchase of Fortetropin in February 2011, we have been focusing on the discovery, development, and
commercialization of nutritional supplements, functional foods, therapeutic products, and other technologies aimed at maintaining or
improving the health and performance of muscle tissue. Our officers, directors and members of our Scientific Advisory Board, including
Dr. Robert Hariri, Dr. Louis Aronne, Dr. Neilank Jha and Dr. Caroline Apovian, have significant research and development experience.
While Fortetropin is our first proprietary ingredient, we plan to discover, develop, formulate and/or acquire additional products in the
future.
We are developing nutritional and therapeutic products aimed at maintaining and improving the health and performance of muscle
tissue. One current target of research which we are actively evaluating is the modulation of myostatin. Our research is focused on
developing strategies and therapeutic interventions to address muscle related conditions including sarcopenia, cachexia, and inherited and
acquired muscle diseases as described in more detail below.
● Sarcopenia is a degenerative process characterized by the progressive loss of muscle mass with advancing age. The loss of muscle
affects all individuals regardless of ethnicity or gender although the rate and degree of muscle loss varies between individuals and is
affected by many factors. Those individuals who have lost significant amounts of muscle mass and strength often require assistance
for accomplishing daily living activities, which has a significant economic burden on a nation’s healthcare system and impacts the
overall economy. In addition to the many direct costs, sarcopenia adversely affects the overall quality of life.
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● Cachexia is a syndrome that occurs in many diseases such as cancer, chronic heart failure, chronic kidney failure and AIDS. It is
characterized by a loss of body weight as a consequence of pathological changes in different metabolic pathways, with the loss of
muscle mass as the core component of the syndrome. Cachexia leads to a poor quality of life and increased mortality. As skeletal
muscle is diminished, individuals experience a reduced ability to move, a loss of strength, and an increase in conditions associated
with immobility such as thrombosis, pneumonia, respiratory failure and ultimately death. Weight loss is an important prognosticator
in cancer therapy with the greater the weight loss the shorter the survival time. Weight loss in cancer patients due to cachexia arises
from the loss of both adipose tissue and skeletal muscle.
● Inherited and acquired muscle diseases, such as muscular dystrophy and muscle dysfunction that occur as a consequence of
denervation such as seen in amyotrophic lateral sclerosis (ALS), are conditions marked by the progressive deterioration of muscle
tissue that results in weakness and impairs normal function. These diseases are typified by difficulty with walking, balance, and
coordination with many such diseases affecting speech, swallowing, and breathing. There are currently no cures for degenerative
muscle diseases outside of palliative care.
Myostatin
Myostatin, which is a natural regulatory protein, plays a central role in skeletal muscle health. Interest in myostatin continues to
grow within the medical community. Research on animals and humans with genetic deficiency for producing myostatin have shown an
increased muscle mass, suggesting that myostatin is responsible for down-regulating muscle growth and development.
A 1997 article in the journal Nature first described the discovery of a novel member of the transforming growth factor-β (TGF-β)
superfamily of growth and differentiation factors. This factor was expressed specifically in adult skeletal muscle and referred to as
growth/differentiation factor-8 (GDF-8) (McPherron et al., 1997). The researchers created “knockout” mice, whereby they disrupted the
expression of GDF-8 throughout the organism, with the resulting mice showing a large and widespread increase in skeletal muscle mass.
Individual muscles of mutant animals weighted 2-3 times more than those of wild-type animals, with the increase a result of both muscle
cell hypertrophy and hyperplasia. The newly created mice were subsequently named “mighty mice”. Based on the phenotype, the
researchers dubbed the newly discovered protein myostatin.
This work suggests myostatin exerts an effect on both muscle hypertrophy and hyperplasia, as myostatin knock-out “mighty mice”
were shown to have an increase in both the number of muscle fibers and in fiber sizes. Hypertrophy refers to the enlargement of a tissue or
organ due to the enlargement of its component cells. In contrast, hyperplasia refers to an increase in the number of cells or a proliferation of
cells. Both of these processes can lead to enlargement of an organ.
Skeletal muscle is the primary producer of myostatin, where it is secreted into the blood stream and acts as a negative regulator of
muscle differentiation and growth. The protein begins as a 375 amino acid dimer that is cleaved by proteases to a 109 amino acid active
domain. The active form of the protein binds to activin type II receptors, ActRIIA and ActRIIB (Lee et al., 2001). Binding to the receptors
initiates a signaling cascade that results in an increase in protein breakdown and subsequent inhibition of protein synthesis.
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Clinical Research to Evaluate Effects of Fortetropin
In March 2013, we completed a human clinical trial which confirmed the beneficial effects of Fortetropin in suppressing free
serum myostatin levels. In this double blind, randomized placebo controlled, parallel, single dose study involving 12 healthy adult male
subjects per arm, test subjects in the active arm were administered a 6.6 gram dose of Fortetropin mixed with vanilla fat free/sugar free
pudding. An equal amount of vanilla fat free/sugar free pudding alone was given to the placebo arm. Blood samples were collected at
baseline (before dosing) and at 6, 12, 18, and 24 hours post dose intervals for measurement of myostatin blood concentration. Results
demonstrated greater than 30% decrease in serum myostatin levels compared to baseline during the 24 hour period. No study related
adverse events were reported during this study.
In another study performed on behalf of the Company at the University of Tampa, a double-blind, placebo controlled trial
examined the effects of Fortetropin on skeletal muscle growth, lean body mass, strength, and power in recreationally trained individuals
who rely heavily on satellite cell activation. Forty-five subjects were divided into placebo, 6.6 gram and 19.8 gram dosing arms of
Fortetropin daily for a period of 12 weeks. All exercise sessions were conducted and monitored by trained personnel. Standardized diets
consisted of roughly 54% carbohydrates, 22% fat and 24% protein. There were no differences in total calories and macronutrients between
groups. Dual emission X-ray absorptiometry was utilized to measure lean body mass and fat mass. Direct ultrasound measurements
determined muscle thickness of the quadriceps.
Results demonstrated a statistically significant increase in both muscle thickness and lean body mass in subjects taking Fortetropin
but not in subjects taking placebo. Strength and power endpoints, as measured by bench press, leg press and Wingate power, significantly
increased from baseline in all study groups. No study related adverse events were reported during the study.
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* p <0.05 post measurement compared to pre
Association between Muscular Strength and Mortality
In a clinical study at the Karolinska Institutet’s Department of Biosciences and Nutrition at NOVUM, Unit for Preventive
Nutrition, in Huddinge, Sweden, 8,762 men aged 20-80 were evaluated over an average period of 18.9 years in a prospective cohort study to
measure the association between muscular strength and mortality in men. After adjusting for age, physical activity, smoking, alcohol intake,
body mass index, baseline medical conditions, and family history of cardiovascular disease, the study found that muscular strength is
inversely and independently associated with deaths from all causes and cancer in men. The findings were valid for men of normal weight,
those who were overweight, and younger or older men, and were valid even after adjusting for several potential confounders, including
cardiorespiratory fitness. This study extends previous studies that showed the importance of muscular strength as a predictor of death from
all causes, cardiovascular disease, and cancer in a large cohort of men. Several prospective studies have also shown that muscular strength
is inversely associated with all-cause mortality. These data suggests that muscular strength adds to the protective effect of cardiorespiratory
fitness against the risk of death in men. Moreover, it might be possible to reduce all-cause mortality among men by promoting regular
resistance training.
We believe improving lean muscle mass should be a therapeutic objective in the management of aging and chronic illness and all
individuals seeking optimal wellness. Fortetropin, the only clinically proven natural myostatin reducing agent available to increase muscle
mass and lean body mass, provides us with a compelling product in the competitive marketplace. Further studies are planned to examine its
role in the treatment of many disease states in various dosing regimens and delivery mechanisms.
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WADA Compliance
Fortetropin® has received Certified Drug Free® certification from the Banned Substances Control Group (BSCG). The BSCG
Certified Drug Free® program is a comprehensive certification program for the dietary supplement industry and includes screening for
substances prohibited by the World Anti-Doping Agency (WADA) along with most U.S. professional sports leagues. WADA is a
foundation created through a collective initiative led by the International Olympic Committee to promote, coordinate and monitor the fight
against drugs in sports.
Research and Development
As a bionutritional and biotherapeutics company, we are dedicated to basic and clinical research that supports our existing and
future product portfolio. We are focused on the following areas of research:
Basic Research
● Biochemical characterization of Fortetropin
● Novel biotherapeutics products
● Computational design of novel peptide inhibitors of myostatin
● Identifying proteins, peptides, and lipids responsible for pro-myogenic activity
● Pro-myogenic activity of novel bioactive molecules and formulations
● Cutting edge proteomic and lipidomic approaches
Pre-Clinical Research
● Effect of Fortetropin to reverse disuse atrophy in dogs after orthopedic surgery
● Synergistic effects of Fortetropin and metformin
● Adjunctive approach for management for obesity and type II diabetes
● PK/PD studies of novel bioactive molecules with pro-myogenic activity
Clinical Research
● Effect of Fortetropin on lean muscle mass, thickness and strength in older adults
● Effect of Fortetropin on muscle function and recovery after orthopedic procedures
● We expect our investment in research and development to continue to grow in the future.
Our research program is actively evaluating the many active proteins, lipids and peptides in Fortetropin. We believe our research
programs will establish a basis for the continued submission of patent applications to help protect our intellectual property. We are
dedicated to protecting our innovative technology.
Clinical and Basic Research Programs
We invest in research and development activities externally through academic and industry collaborations aimed at enhancing our
products, optimizing manufacturing and broadening the product portfolio. We have developed the following collaborations with various
academic centers:
● In May 2015, we initiated a dose response clinical study led by Jacob Wilson, Ph.D., CSCS*D, Professor of Health Sciences and
Human performance at the University of Tampa, to examine the effects of Fortetropin supplementation on plasma myostatin levels
at various dosing levels in young adult males and females. This study is intended to help us better define the dose response curve,
the minimal effective dose and effects of Fortetropin on serum myostatin. In this double blind placebo controlled clinical study, 80
male and female subjects ranging in ages between 18 and 22 were randomized into four groups such that no significant differences
in serum myostatin concentration existed between groups. Following assignment to one of the four groups, blood samples were
collected to establish baseline values. Subjects were subsequently supplemented with three different doses of Fortetropin (2.0g, 4.0g
and 6.6g) and a matching placebo for one week. Following a week of supplementation, blood samples were collected and serum
myostatin levels were assayed. Results demonstrated that Fortetropin is effective as a myostatin reducing agent at daily doses of
4.0g and 6.6g. This research, which continues to build upon our current knowledge of Fortetropin, may result in the formulation of
new products. An abstract of this study was presented at the 2016 International Conference on Frailty & Sarcopenia Research in
April 2016.
● In August 2014, we entered into a research agreement with Human Metabolome Technologies America, Inc., (“HMT”), to apply
their proprietary, state-of-the-art capillary electrophoresis-mass spectrometry (CE-MS)
the
metabolomic profiles of plasma samples obtained from healthy male subjects who used either Fortetropin or placebo with the goal
of identifying metabolites with pro-myogenic activity in the plasma samples of subjects who took Fortetropin as well as examining
the effect on glucose and fat metabolism. HMT used a metabolite database of over 290 lipids and over 900 metabolites to identify
potential plasma biomarkers of muscle growth. The study was completed during the fourth quarter of 2014. Initial data from this
study indicated that subjects who received Fortetropin displayed differential metabolomic profiles relative to subjects who received
placebo. The results of this study enhance our understanding of the mechanism of action of Fortetropin and provides guidance for
the development of biotherapeutics based on Fortetropin. Additionally, the early indications of plasma biomarkers may guide future
study design for Fortetropin clinical trials by identifying clinically-relevant endpoints and potential stratification of patient
populations.
to characterize
technologies
9
● In May 2014, we entered into an agreement with the University of Tampa to study the effects of Fortetropin supplementation in
conjunction with modest resistance training in average men. The study was a double-blind, placebo-controlled trial which examined
the effects of Fortetropin on skeletal muscle growth, lean body mass, strength, and power in recreationally trained males. Forty-five
subjects were divided into placebo, 6.6g and 19.8g dosing arms of Fortetropin daily for a period of 12 weeks. Results demonstrated
a statistically significant increase in both muscle thickness and lean body mass in subjects taking Fortetropin but not in subjects
taking placebo. The clinical study also analyzed blood myostatin and cytokines levels via high-sensitivity enzyme-linked
immunosorbent assay (“ELISA”) based spectrophotometric. Serum was analyzed for a plethora of relative cytokine levels via high-
sensitivity enhanced chemiluminescent-based methods. The Interferon-Gamma (“IFN-γ”) inflammatory cytokine protocol screening
showed no statistically significant changes in serum levels of IFN-γ for subjects in the placebo group. However, subjects in both
Fortetropin daily dosing arms experienced statistically significant decreases (p < 0.05) in serum levels of the IFN-γ inflammatory
cytokine. IFN-γ is recognized as a signature pro-inflammatory cytokine protein that plays a central role in inflammation and
autoimmune diseases. Excess levels of inflammatory cytokines are associated with muscle-wasting diseases such as sarcopenia and
cachexia. The lipid serum safety protocol demonstrated that daily use of Fortetropin at recommended and three times the
recommended dose had no adverse lipid effect and did not adversely affect cholesterol, HDL or triglyceride levels. Data from the
study was presented at the American College of Nutrition’s 55th annual conference. A separate mechanism of action study at the
University of Tampa demonstrated that in addition to reducing serum myostatin levels, Fortetropin showed activity in mTOR and
Ubiquitin pathways, two other crucial signaling pathways in the growth and maintenance of healthy muscle. Specifically, the
preclinical data showed that Fortetropin up-regulates the mTOR regulatory pathway. The mTOR pathway is responsible for
production of a protein kinase related to cell growth and proliferation that increases skeletal muscle mass. Up-regulation of the
mTOR pathway is important in preventing muscle atrophy. We believe Fortetropin's ability to affect the mTOR pathway may have
a significant impact in treating patients suffering from degenerative muscle diseases and suggests that Fortetropin-based products
may help slow muscle loss secondary to immobility and denervation. The preclinical data also demonstrated that Fortetropin acts to
reduce the synthesis of proteins in the Ubiquitin pathway, a highly selective, tightly regulated system that serves to activate muscle
breakdown. Over-production in the Ubiquitin pathway is responsible for muscle degradation. We believe Fortetropin's ability to
regulate production in the Ubiquitin pathway may have significant implications for repairing age-related muscle loss and for
patients suffering from chronic diseases causing cachexia.
● In May 2014, we entered into a three-year master service agreement with Rutgers University. The initial phase under the agreement
was to develop cell-based assays for high-throughput screening studies of next generation myostatin inhibitors. Additionally, we
initiated a second phase of the agreement to develop a secondary assay for measuring myostatin activity using a genetically
engineered muscle cell line that fluoresce in the presence of myostatin. Phase I and II were completed in 2015. We believe the
assays developed will enable us to elucidate the specific molecules in Fortetropin that impart activity as it relates to the development
of muscle tissue.
The foregoing agreements are an integral part of our business strategy and we believe they will provide a clear scientific rationale
for Fortetropin's role as a nutritional product and support its use in different medical and health applications in the future.
We are also building a small molecule and biologics discovery program aimed at regulators of myostatin synthesis and activation
and the different pathways that act upon muscle development. In July 2014, we entered into a research and development agreement with
Cloud Pharmaceuticals, Inc., (“Cloud”), to discover product candidates related to the inhibition of targets in the myostatin regulatory
pathway as well as inflammatory mediators associated with sarcopenia and cachexia. Cloud utilizes cloud computing technology to initiate
and design small molecule drug candidates based on their Inverse Design proprietary cheminformatics tool. The research is focusing on the
development of product candidates related to the myostatin pathway. Cloud has identified several peptides that may have myostatin
inhibition properties. We intend to evaluate the physiological activity of these peptides on myostatin.
We intend to pursue additional clinical studies and medical research to support differentiated and advantaged marketing claims, to
build and enhance our competitive insulation via strategically based additional intellectual property, to develop product improvements and
new products in consumer preferred dosage forms, to enhance overall marketing, to establish a scientific foundation for therapeutic
applications for our technology, and to pursue best in class personnel.
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Strategic Investment Transaction
On December 17, 2015, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with RENS
Technology Inc. (the “Purchaser”), pursuant to which the Purchaser agreed to invest $20.25 million in the Company (the “Financing”) in
exchange for (i) an aggregate of 3,537,037 shares (the “Shares”) of the Company’s common stock, par value $0.001 per share (“Common
Stock”), and (ii) warrants to purchase an aggregate of 884,259 shares of Common Stock (the “Warrants”, and together with the Shares, the
“Securities”). The Purchaser agreed to purchase the Securities in three tranches over twenty-four months. In the first tranche, which closed
on March 3, 2016, the Purchaser acquired 1,500,000 Shares and a warrant to purchase 375,000 shares of Common Stock (the “First Closing
Warrant”) for $5.25 million. In the second tranche, which we had expected to close in September 2016, the Purchaser would have acquired
925,926 Shares and a warrant to purchase 231,481 shares of Common Stock (the “Second Closing Warrant”) for $5.0 million. In the third
tranche, which we had expected to close within eighteen months of the closing of the second tranche, the Purchaser would have acquired
1,111,111 Shares and a warrant to purchase 277,778 shares of Common Stock (the “Third Closing Warrant”) for $10.0 million.
Each of the Warrants would have been immediately exercisable upon issuance, would expire five years after issuance and would
have the following exercise prices: (a) $7.00 per share for the First Closing Warrant, (b) $10.80 per share for the Second Closing Warrant
and (c) $18.00 per share for the Third Closing Warrant. In addition, the Company agreed: (i) that the Purchaser would have the right to
appoint four persons to the Company’s board of directors, subject to adjustment based on the Purchaser’s ownership percentage of the
Company; (ii) to provide the Purchaser with a right to participate in 50% (or 100% if shares are to be issued for less than $3.50 per share) of
any future financings pursued by the Company within 12 months from the closing of the third tranche of the Financing; and, (iii) until the
closing of the third tranche, the Company would not take certain actions, including issuing shares (except for certain permitted issuances)
or appointing new officers and directors, without the Purchaser’s consent (collectively the “Purchaser’s Rights”).
On August 19, 2016, the Purchaser notified the Company that it did not intend to fulfill its obligation to fund the second tranche of
the Financing, notwithstanding its confirmation to the Company in June 2016 that the Purchaser would provide such funding in accordance
with the terms of the Purchase Agreement.
The Purchase Agreement provides that in the event that the Purchaser notifies the Company that it does not intend to fund the
Second Closing Subscription Amount, the Purchaser is required to take all requisite action to cause the resignation or removal of one of its
designees on the Board of Directors of the Company. Pursuant to the terms of the Purchase Agreement, effective August 23, 2016, Guiying
Zhao resigned as a director of the Company. In addition, the Purchaser’s Rights terminated, effective August 19, 2016.
On January 6, 2017, the Company commenced an action in the Supreme Court of New York, County of New York, against the
Purchaser, the parent company of the Purchaser, and Ren Ren, a principal in both entities and a director of the Company, arising from the
Purchaser’s breach of the Purchase Agreement under which the Purchaser agreed to invest an aggregate of $20.25 million in the Company
in exchange for an aggregate of 3,537,037 shares of common stock of the Company and warrants to purchase an aggregate of 884,259
shares of common stock. In addition to seeking compensatory, consequential and other damages in the action, the Company asked the Court
to preliminarily restrain the Purchaser and its agents and representatives, including, but not limited to, RENS Agriculture and Ren Ren, from
selling, transferring, conveying, assigning, hypothecating or encumbering 1,500,000 shares of common stock of the Company and a
warrant permitting the purchase of 375,000 share at a price of $7.00 per share that the Purchaser had purchased under the Purchase
Agreement and, after the parties had an opportunity to submit opposition and reply papers in connection with the Company’s application, a
preliminary injunction prohibiting RENS Technology from selling, transferring, conveying, assigning, hypothecating or encumbering the
1,500,000 shares and warrant during the pendency of the action and an order attaching the stock and warrant to satisfy any judgment entered
in favor of the Company.
On January 11, 2017, the Court granted the Company the preliminary restraints that it requested, which prevents the Purchaser,
among others, from selling, transferring, conveying, assigning, hypothecating or encumbering the 1,500,000 shares of the Company’s
common stock or the aforementioned warrant. The Court scheduled a hearing on February 14, 2017, at which time the Court heard oral
argument on the application for a preliminary injunction and prejudgment attachment of the stock and warrants to satisfy any judgment
entered in favor of the Company. Since then, the Purchaser filed a motion to dismiss the complaint which the Company has opposed. No
decision has been made by the Court on these two pending applications.
Market Overview
According to the Natural Marketing Institute, the Dietary Supplement, Functional Food and Beverage, and Natural Personal Care
markets represent more than $250 billion in annual worldwide sales. The global market for functional foods alone in 2016 was worth an
estimated $43.3 billion. In 2017, it is expected to grow to $54 billion, and the United States is expected to be the fastest growing market for
functional foods. The global sports nutrition market was valued at $28.4 billion in 2016, and is expected to grow at a compounded annual
growth rate of 8.1% during the period from 2017 to 2022 up to $45 billion. We believe our proprietary ingredient, Fortetropin, which is the
only clinically proven natural supplement available in the market that temporarily reduces free serum myostatin level, is well-positioned to
market to a wide base of consumers looking for nutritional and performance maximization as well as for wellness and maintenance products
as they age. Additionally, the medical community has increased its focus on muscle health, specifically focusing on the aging U.S.
population that can benefit most from myostatin modulation. We believe persons suffering from sarcopenia, a muscle loss condition due to
aging, and cachexia, a syndrome characterized by loss of body weight in many diseases such as cancer, may also benefit from Fortetropin
as muscle loss can be slowed by a reduction of myostatin in the body.
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We believe the combination of the foregoing marketplace characteristics, combined with the experience of our directors and our
management team and our current and future products, will enable our business model to succeed.
Strategy
Our strategy is to understand the complex genetic and molecular pathways regulating muscle mass and function as well as other
disease mechanisms. Understanding the impact of complex regulatory pathways which act to build and maintain healthy lean muscle is
central to our biotherapeutic research. This research is the foundation of our bionutritional product development. We are developing
nutritional products that target specific mechanisms to promote health in ways that cannot be met by other treatments, diets or lifestyle
changes.
We will seek to gain market share for our core branded products in functional foods, sports and fitness nutrition and rehab and
restorative health verticals by (i) formulating and developing new and complementary product lines, (ii) expanding U.S. distribution by
increasing the channels of sale, (iii) expanding distribution geography beyond the U.S., including China and Southeast Asia and (iv)
seeking strategic relationships with other distributors. Our strategy is to utilize the revenue and awareness generated by the sales and
marketing of Fortetropin to further advance our research and development of nutritional and therapeutic treatments for muscular-related
conditions, including sarcopenia.
Marketing, Sales and Distribution
Our commercial focus is to leverage our clinical data to develop multiple products to target the large, but currently underserved,
markets focused on muscle health. The sales channels through which we sell our products are evolving. The first product we introduced
was MYO-T12, which was sold in the sports nutrition market. MYO T-12 is a proprietary formula containing Fortetropin and other
ingredients. The formula was sold under the brand name MYO T-12 and later as MYO-X through an exclusive distribution agreement with
Maximum Human Performance (“MHP”). The exclusive distribution agreement with MHP terminated in March 2015. The Company had
sales to MHP of $57 in 2015. There were no sales to MHP in 2016 and we do not expect any orders from MHP in 2017.
In February 2014, we expanded our commercial operations into the age management market through a distribution agreement with
Cenegenics Product and Lab Services, LLC (“Cenegenics”), under which Cenegenics distributes and promotes a proprietary formulation
containing Fortetropin through its age management centers and its community of physicians focused on treating a growing population of
patients focused on proactively addressing age-related health and wellness concerns. On November 28, 2014, we entered into a settlement
agreement with Cenegenics wherein we agreed to accept $1.9 million by April 2016, (i.e., $300 thousand in the fourth quarter of 2014 and
$100 thousand per month from January 2015 through April 2016) in full satisfaction of Cenegenics’ outstanding obligations with respect to
units of product produced by the Company, including units that had not yet been shipped to Cenegenics at the time of the settlement
agreement. In exchange, we agreed to withdraw our October 10, 2014 request for arbitration before the International Chamber of
Commerce. During the second quarter of 2015, Cenegenics accepted delivery of the remaining units that we were storing on its behalf.
Given the settlement agreement’s extended payment schedule, the Company deferred the revenue and related cost associated with the
shipment and will record the revenue and cost of sales when the related payments are received, which is expected to be in early 2016. The
distribution agreement with Cenegenics expired in December 2016. The Company does not expect any sales to Cenegenics in 2017.
During the second quarter of 2015 we launched Rē Muscle HealthTM, our own direct-to-consumer portfolio of muscle health bars,
meal replacement shakes and daily supplement powders each powered by a full 6.6 gram single serving dose of Fortetropin. Our Rē Muscle
Health products were sold through our e-commerce website, remusclehealth.com, and amazon.com until March 2017 when we introduced
our new Qurr line of products.
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On March 13, 2017 the Company launched Qurr, its Fortetropin®-powered product line formulated to support the vital role of
muscle in overall well-being as well as in fitness. The introduction of Qurr's muscle-focused, natural, over-the-counter products will make
the Qurr line available through convenient direct online ordering without a prescription. All Qurr products are blended with Fortetropin®,
MYOS' proprietary ingredient which has been clinically demonstrated to reduce serum myostatin levels, which helps increase muscle size
and lean body mass. MYOS' earlier product formulations featuring Fortetropin® have become part of the daily routine of many athletes
and fit-conscious people.
Qurr is a line of deliciously flavored puddings, powders, and shakes all proven to be safe for daily use. While pharmaceutical
companies are working on drugs to accomplish what Fortetropin® already does, there is no pharmaceutical drug that can reduce myostatin,
safely. Fortetropin® has been shown in clinical trials to reduce serum myostatin levels and increase lean muscle mass and thickness when
taken in conjunction with resistance training. Testimonials from enthusiastic core users of Fortetropin® also describe increases in lean
muscle mass and thickness when combined with exercise.
We continue to pursue additional distribution and branded sales opportunities. There can be no assurance that we will be able to
secure distribution arrangements on terms acceptable to the Company, or that we will be able to generate significant sales of our current
and future branded products. We expect to continue developing our own core branded products in markets such as functional foods, sports
and fitness nutrition and rehab and restorative health and to pursue international sales opportunities. The growing awareness of the potential
therapeutic uses of myostatin reducing agents supports continued development of our own core products. We remain committed to
continuing our focus on various clinical trials in support of our marketing claims as well as to enhance our intellectual property, to develop
product improvements and new products, and to reduce the cost of our products by finding more efficient manufacturing processes and
contract manufacturers.
Intellectual Property
We have adopted a comprehensive intellectual property strategy, the implementation of which is ongoing. We are focusing our
efforts on ensuring our current commercial products and processes, and those currently under development, are being protected to the
maximum extent possible. We are in the process of filing multiple patent applications in the United States and abroad, and we are currently
prosecuting pending patent applications in the United States, all of which are directed towards our compositions and methods of
manufacturing the same. In addition to a proactive protection strategy, we are conducting defensive diligence to ensure our products and
processes do not encroach upon the rights of third parties. Moreover, we are also engaged in a survey of the intellectual property owned by
potential competitors, and are devising a proactive path to stay ahead of such potential competitors.
In August 2014, the U.S. Patent and Trademark Office, or USPTO, issued U.S. Patent No. 8,815,320 B2 to us covering our
proprietary methods of manufacturing Fortetropin. The patent entitled “Process for Producing a Composition Containing Active
Follistatin,” provides intellectual property protection for making Fortetropin, the key ingredient in our core commercial muscle health
products, and carries a patent term through early 2033. Additionally, we are currently prosecuting a core patent application covering the
basic science on which our business was built, which application is currently undergoing examination at the USPTO. The scope of this
application covers the various applications of avian follistatin products and the benefits thereof. In particular, this application is focused on
the composition currently in our commercially sold Fortetropin-powered products and the known benefits thereof.
We intend to file as many applications as possible as continuation/divisional/continuation-in-part applications. Several additional
pending patent applications that we are pursuing include:
● Method of obtaining effective amounts of avian follistatin - covering a method of controlling the amount of avian follistatin and the
concentrations thereof within a product by extracting the proteins from various parts of fertilized and unfertilized avian eggs.
● Methods of treating degenerative muscle disease – covering methods of treating various degenerative muscle diseases, such as
sarcopenia, with avian egg-based products and the compositions thereof.
● Methods and products for increasing muscle mass – covering various combinations of proteins, lipids and other molecules, which
are active in the natural form of our core commercial products, which may be combined in advantageous amounts to yield improved
products and methods for increasing muscle mass.
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● Egg-based product having hydroxymethylbutyrate, or HMB, for the treatment of degenerative muscle disease – covering a line of
products combining avian egg-based products with HMB for improved treatment of degenerative muscle diseases and the methods
of treating the same.
● Egg-based product having leucine for treatment of degenerative muscle disease - covering a line of products combining avian egg-
based products with leucine for improved treatment of degenerative muscle diseases and the methods of treating the same.
● Methods of treatment of degenerative muscle disease using egg-based products and testosterone replacement therapy – covering
methods of treating degenerative muscle disease in combination with testosterone replacement therapy for improved results.
● Methods of treatment of cancer using avian egg powder.
● Methods of treatment of insulin resistance and Type II diabetes using avian egg powder.
● Methods of treatment of neurological diseases using avian egg powder.
● Method of enhancing overall health and longevity using avian egg powder.
In addition to patent protection, we are also engaged in protecting our brands, including corporate brands and product brands, and
have sought trademark registrations in the United States for the same. We have implemented a clearance strategy for new brands we intend
to launch, to ensure any risk of encroaching on the rights of third parties is minimized.
We regard our trademarks and other proprietary rights as valuable assets and believe that protecting our key trademarks is crucial
to our business strategy of building strong brand name recognition. These trademarks are crucial elements of our business, and have
significant value in the marketing of our products. Federally registered trademarks have a perpetual life, provided that they are maintained
and renewed on a timely basis and used correctly as trademarks, subject to the rights of third parties to attempt to cancel a trademark if
priority is claimed or there is confusion of usage. We rely on common law trademark rights to protect our unregistered trademarks.
Common law trademark rights generally are limited to the geographic area in which the trademark is actually used, while a United States
federal registration of a trademark enables the registrant to stop the unauthorized use of the trademark by third parties in the United States.
Much of our ongoing work, including our research and development, is kept highly confidential. As such, we are in the process of adopting
corporate confidentiality policies that comply with the Uniform Trade Secrets Act and the New Jersey Trade Secret Act to protect some of
our most valuable intellectual property assets.
Regulatory Environment
The importing, manufacturing, processing, formulating, packaging, labeling, distributing, selling and advertising of our current and
future products may be subject to regulation by one or more federal or state agencies. The Food and Drug Administration, or the FDA, has
primary jurisdiction over our products pursuant to the Federal Food, Drug and Cosmetic Act, as amended by the Dietary Supplement and
Health Education Act, or the FDCA, and the regulations promulgated thereunder. The FDCA provides the regulatory framework for the
safety and labeling of dietary supplements, foods and medical foods. In particular, the FDA regulates the safety, manufacturing, labeling
and distribution of dietary supplements. In addition, the Animal Plant Health and Inspection Service, or APHIS, regulates the importation
of our primary product from Germany. The Federal Trade Commission, or the FTC, and the FDA share jurisdiction over the promotion and
advertising of dietary supplements. Pursuant to a memorandum of understanding between the two agencies, the FDA has primary
jurisdiction over claims that appear on product labels and labeling and the FTC has primary jurisdiction of product advertising.
The term “medical foods” does not pertain to all foods fed to sick patients. Medical foods are prescription foods specially
formulated and intended for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal diet
alone. They were defined in the FDA’s 1988 Orphan Drug Act Amendments and are subject to the general food safety and labeling
requirements of the FDCA but are exempt from the labeling requirements for health claims and nutrient content claims under the Nutrition
Labeling and Education Act of 1990. Medical foods are distinct from the broader category of foods for special dietary use and from
traditional foods that bear a health claim. In order to be considered a medical food, a product must, at a minimum, be a specially formulated
and processed product (as opposed to a naturally occurring food in its natural state) for oral ingestion or tube feeding (nasogastric tube), be
labeled for the dietary management of a specific medical disorder, disease or condition for which there are distinctive nutritional
requirements and be intended to be used under medical supervision.
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Compliance with applicable federal, state, and local laws and regulations is a critical part of our business. We endeavor to comply
with all applicable laws and regulations. However, as with any regulated industry, the laws and regulations are subject to interpretation and
there can be no assurances that a government agency would necessarily agree with our interpretation of the governing laws and regulations.
Moreover, we are unable to predict the nature of such future laws, regulations, interpretations or applications, nor can we predict what
effect additional governmental regulations or administrative orders, when and if promulgated, would have on our business in the future.
These regulations could, however, require the reformulation of our products to meet new standards, market withdrawal or discontinuation
of certain products not able to be reformulated. The risk of a product recall exists within the industry although we endeavor to minimize the
risk of recalls by distributing products that are not adulterated or misbranded. However, the decision to initiate a recall is often made for
business reasons in order to avoid confrontation with the FDA.
Our products are required to be prepared in compliance with the FDA’s Good Manufacturing Practices, or GMPs, for dietary
supplements. Fortetropin, the active ingredient in our products, must be imported into the United States in conformance with APHIS’s
requirements for egg products. Other statutory obligations include reporting all serious adverse events on a Medwatch Form 3500A. To
date, we have not filed a Medwatch Form 3500A with the FDA nor have we been placed on notice regarding any serious adverse events
related to any of our products. Since eggs are considered a major food allergen under the Food Allergen Labeling and Consumer Protection
Act of 2004, we are required to label all our products containing Fortetropin to note that they contain egg product.
Advertising of dietary supplement products is subject to regulation by the FTC under the Federal Trade Commission Act, or
FTCA, which prohibits unfair methods of competition and unfair or deceptive trade acts or practices in or affecting commerce. The FTCA
provides that the dissemination of any false advertising pertaining to foods, including dietary supplements, is an unfair or deceptive act or
practice. Under the FTC's substantiation doctrine, an advertiser is required to have a reasonable basis for all objective product claims before
the claims are made. All advertising is required to be truthful and not misleading. All testimonials are required to be typical of the results
the consumer may expect when using the product as directed. Accordingly, we are required to have adequate substantiation of all material
advertising claims made for our products. Failure to adequately substantiate claims may be considered either deceptive or unfair practices.
In March 2009, the General Accounting Office, or GAO, issued a report that made four recommendations to enhance the FDA’s
oversight of dietary supplements. The GAO recommended that the Secretary of the Department of Health and Human Services direct the
Commissioner of the FDA to: (i) request authority to require dietary supplement companies to identify themselves as a dietary supplement
company and update this information annually, provide a list of all dietary supplement products they sell and a copy of the labels and
update this information annually, and report all adverse events related to dietary supplements, not just serious adverse events; (ii) issue
guidance to clarify when an ingredient is considered a new dietary ingredient, the evidence needed to document the safety of new dietary
ingredients, and appropriate methods for establishing ingredient identity; (iii) provide guidance to industry to clarify when products should
be marketed as either dietary supplements or conventional foods formulated with added dietary ingredients; and (iv) coordinate with
stakeholder groups involved in consumer outreach to identify additional mechanisms for educating consumers about the safety, efficacy,
and labeling of dietary supplements, implement these mechanisms, and assess their effectiveness. These recommendations could lead to
increased regulation by the FDA or future legislation concerning dietary supplements.
In addition, medical foods must comply with all applicable requirements for the manufacture of foods, including food Current
Good Manufacturing Practices (“cGMP”), registration of food facility requirements and, if applicable, FDA regulations for low acid canned
food and emergency permit controls. The FDA considers the statutory definition of medical foods to narrowly constrain the types of
products that fit within this category of food. The FDA inspects medical food manufacturers annually to assure the safety and integrity of
the products. Failure of our contract manufacturers to comply with applicable requirements could lead to sanctions that could adversely
affect our business.
We cannot predict what effect additional domestic or international governmental legislation, regulations, or administrative orders,
when and if promulgated, would have on our business in the future. New legislation or regulations may require the reformulation of certain
products to meet new standards, require the recall or discontinuance of certain products not capable of reformulation, impose additional
record keeping or require expanded documentation of the properties of certain products, expanded or different labeling or scientific
substantiation.
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Manufacturing; Raw Materials and Suppliers
We are committed to producing and selling highly efficacious products that are trusted for their quality and safety. To date, our
products have been outsourced to third party manufacturers where the products are manufactured in full compliance with cGMP standards
set by the FDA. All of the raw materials for our current products are currently sourced from third-party suppliers. Any shortages in our raw
materials could result in materially higher raw material prices and adversely affect our ability to source our product. Since the beginning of
2012, we have been focusing on the efficiency and economics of manufacturing Fortetropin. Our management has examined the production
cost and is working to achieve cost savings in production.
We currently have an agreement with only one third-party manufacturer of Fortetropin, who will manufacture the formula
exclusively for the Company in perpetuity, and may not manufacture the formula for other entities. We have multiple vendors for blending,
packaging and labeling our products.
Competition
Given the large patient populations that could potentially benefit from treatments targeted at myostatin, a number of
pharmaceutical companies are currently developing various types of myostatin inhibitors. Eli Lilly and Co., Novartis AG, Pfizer Inc.,
Regeneron Pharmaceuticals Inc., Sanofi S.A., Scholar Rock and Acceleron Pharma Inc, are among the companies that we are aware of that
are testing new compounds in the field of myostatin inhibition. The market for nutritional supplements is highly competitive. Companies
operating in the space include PepsiCo Inc., Glanbia Plc. GNC Holdings, The Coca-Cola Company, GlaxoSmithKline, Abbott
Laboratories, Nestle S.A. and Universal Nutrition. Competition is based on price, quality, customer service, marketing and product
effectiveness. Our competition includes numerous nutritional supplement companies that are highly fragmented in terms of geographic
market coverage, distribution channels and product categories. In addition, large pharmaceutical companies and packaged food and
beverage companies compete with us in the nutritional supplement market. These companies and certain nutritional supplement companies
have broader product lines and/or larger sales volumes than us and have greater financial and other resources available to them and possess
extensive manufacturing, distribution and marketing capabilities. Other companies are able to compete more effectively due to a greater
extent of vertical integration. Private label products of our competitors, which in recent years have significantly increased in certain
nutrition categories, compete directly with our products. In several product categories, private label items are the market share leaders.
Increased competition from such companies, including private label pressures, could have a material adverse effect on our results of
operations and financial condition. Many companies within our industry are privately-held and therefore, we are unable to assess the size of
all of our competitors or where we rank in comparison to such privately-held competitors with respect to sales.
Insurance
We maintain commercial liability, including product liability coverage, and property insurance. Our policy provides for a general
liability of $5.0 million per occurrence, and $10.0 million annual aggregate coverage. We carry property coverage on our main office
facility to cover our legal liability, tenant’s improvements, business property, and inventory. We maintain product liability insurance with
an aggregate cap on retained loss of $10.0 million.
Employees
We currently have nine full-time employees (including one executive officer). We also employ several consultants. None of our
employees are represented by a labor union and we consider our employee relations to be good.
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Item 1A. Risk Factors.
Our business, operations and financial condition are subject to various risks. Investing in our securities involves a high degree of
risk. Before purchasing our common stock, you should carefully consider the following risk factors as well as other information contained
in this report, including our financial statements and the related notes. The risks and uncertainties described below are not the only ones
facing us. Additional risks and uncertainties that we are unaware of, or that we currently deem immaterial, also may become important
factors that affect us. If any of the following risks occurs, our business, financial condition or results of operations could be materially and
adversely affected. In that case, the trading price of our securities could decline, and you may lose some or all of your investment. Amounts
in this section are in thousands, unless otherwise indicated.
Our limited operating history makes it difficult to evaluate our future prospects and results of operations.
RISKS RELATING TO OUR BUSINESS
We are an early stage company and have a limited operating history. Our future prospects should be considered in light of the risks
and uncertainties experienced by early stage companies in evolving markets such as the market for our current and future products, if any,
in the United States. We will continue to encounter risks and difficulties that companies at a similar stage of development frequently
experience, including the potential failure to:
● build a strong and compelling consumer brand;
● adequately protect and build our intellectual property;
● develop new products;
● conduct successful research and development activities;
● increase awareness of our products and develop customer loyalty;
● respond to competitive market conditions;
● respond to requirements and changes in our regulatory environment;
● maintain effective control of our costs and expenses;
● availability of sufficient capital resources to adequately promote and market our products; and
● attract, retain and motivate qualified personnel.
If we are unable to address any or all of the foregoing risks, our business may be materially and adversely affected.
If we are unable to successfully market and promote our own core branded products, we will not be able to increase our sales and our
business and results of operations would be adversely affected.
We recently launched Qurr, our own proprietary branded products using multiple delivery formats. Successfully marketing and
promoting products is a complex and uncertain process, dependent on the efforts of management, outside consultants and general economic
conditions, among other things. There is no assurance that we will successfully market and/or promote our own core branded products.
Any factors that adversely impact the marketing or promotion of our products including, but not limited to, competition, acceptance in the
marketplace, or delays related to production and distribution or regulatory issues, will likely have a negative impact on our cash flow and
operating results. The commercial success of our products also depends upon various other factors including:
● the quality and acceptance of other competing brands and products;
● creating effective distribution channels and brand awareness;
● critical reviews;
● the availability of alternatives;
● general economic conditions; and
● availability of sufficient capital resources to adequately promote and market our products.
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Each of these factors is subject to change and cannot be predicted with certainty. We cannot assure you that we will be successful
in marketing or promoting any of our own core branded products. If we are unable to successfully market and promote our own core
branded products or any enhancements to our products which we may develop, we will not be able to increase our sales, and our results of
operations would be adversely affected.
We currently do not sell to distributors but if we decide to resume selling to our prior distributors and they are unable or unwilling to
purchase our products and we are unable to secure alternative distributors or customers, our operating results and financial condition
will be adversely affected.
We previously sold our products primarily through two distributors, MHP and Cenegenics. For the year ended December 31,
2015, our net sales were $159, of which 36% was attributable to MHP. For the year ended December 31, 2016, our net sales were $327, of
which 50% was attributable to Cenegenics. We launched our Rē Muscle Health portfolio of branded products in March 2015, which were
not sold to distributors. In March 2017 we launched a new product line Qurr which we will be selling direct to consumers on our website
and Amazon. If we decide to resume selling our products to distributors and our prior distributors are unable or unwilling to purchase our
products and we are unable to secure alternative distributors or customers, our operating results and financial condition will be adversely
affected.
We have a history of losses and cash flow deficits, and we expect to continue to operate at a loss and to have negative cash flow for the
foreseeable future, which could cause the price of our stock to decline.
At December 31, 2016, we had cumulative net losses from inception of $27,786. Our net loss for the years ended December 31,
2016 and 2015 were $4,341 and $5,078, respectively. We also had negative cash flow from operating activities. Historically, we have
funded our operations from the proceeds from the sale of equity securities, debt issuances, and to a lesser extent, internally generated funds.
Our strategic business plan is likely to result in additional losses and negative cash flow for the foreseeable future. We cannot give
assurances that we will ever become profitable.
There is no assurance that we will be able to increase our sales.
Our sales for the year ended December 31, 2016 were $327, a 106% increase compared to sales for the year ended December 31,
2015. This increase was primarily due to recognition of $163.5 sales to Cenegenics related to the collection of deferred revenues and an
increase in our proprietary branded products using multiple delivery formats. We cannot give assurances that our new business model will
enable us to increase our sales.
Our intangible assets, which represent a significant amount of our total assets, are subject to impairment testing and may result in
impairment charges, which would adversely affect our results of operations and financial condition.
At December 31, 2016, our total assets were $5,961, of which $1,527, or approximately 25% represents intangible assets, net of
accumulated amortization. Our intangible assets primarily relate to intellectual property pertaining to Fortetropin, including the MYO-T12
formula, trademarks, trade secrets, patent application and domain names acquired from Peak Wellness, Inc. in February 2011. The
intellectual property asset was initially recorded as an indefinite-lived intangible asset and tested annually for impairment or more
frequently if events or circumstances changed that could potentially reduce the fair value of the asset below its carrying value. Impairment
testing requires the development of significant estimates and assumptions involving the determination of estimated net cash flows,
selection of the appropriate discount rate to measure the risk inherent in future cash flow streams, assessment of an asset’s life cycle,
competitive trends impacting the asset as well as other factors. The Company’s forecasted future results and related net cash flows
contemplate the direct offering of product and successfully establishing future sales channels among other factors. Changes in these
underlying assumptions could significantly impact the asset’s estimated fair value.
In 2011, based on (i) assessment of current and expected future economic conditions, (ii) trends, strategies and projected revenues
and (iii) assumptions similar to those that market participants would make in valuing the Company's intangible assets, management
determined that the carrying values of the intellectual property asset exceeded its fair value. Accordingly, the Company recorded noncash
impairment charges totaling $2,662 and reduced the intellectual property asset to its fair value of $2,000. Management performed annual
impairment tests in 2012, 2013 and 2014 and determined no further impairment existed. During the second quarter of 2015, management
made an assessment and based on expansion into new markets and introduction of new formulas determined that the intellectual property
had a finite useful life of ten (10) years and began amortizing the carrying value of the intellectual property asset over its estimated useful
life. Management made a separate determination that no further impairment existed at that time. Based on ten consecutive quarters of
minimal revenues combined with changes in the sales channels through which we sell our products and our inability to predict future
orders, if any, from MHP or Cenegenics or to what extent we will be able to secure new distribution arrangements, we tested the intellectual
property for impairment in the fourth quarter of 2016 and 2015 and determined that the asset value was recoverable and therefore no
impairment was recognized. Nevertheless, a significant amount of our total assets are subject to impairment testing and may result in
noncash impairment charges, which would adversely affect our results of operations and financial condition.
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We will need to raise additional funds in the future to grow our business. If we are unable to raise funds as needed, we may not be able
to maintain or expand our business.
We require substantial funds for operating expenses, research and development activities, to establish manufacturing capability, to
develop consumer marketing and retail selling capability, and to cover public company costs. The extent of our capital needs will depend
on numerous factors, including (i) our profitability, (ii) the release of competitive products, (iii) the level of investment in research and
development, (iv) the amount of our capital expenditures, (v) the amount of our working capital including collections on accounts
receivable, (vi) the sales, marketing and distribution investment needed to develop and launch our own core branded products and (vii) cash
generated by sales of those products.
We cannot assure you that we will be able to obtain additional financing or that such financing would be sufficient to meet our
needs. If we cannot obtain additional funding, we may be required to limit our marketing efforts, decrease or eliminate capital expenditures
or cease all or a portion of our operations, including any research and development activities. Any available additional financing may not be
adequate to meet our goals.
Even if we are able to locate a source of additional capital, we may not be able to negotiate terms and conditions for receiving the
additional capital that are acceptable to us.
Any future capital investments could dilute or otherwise materially adversely affect the holdings or rights of our existing
stockholders. In addition, new equity or convertible debt securities issued by us to obtain financing could have rights, preferences and
privileges senior to our common stock. There is no assurance that any additional financing will be available, or if available, will be on terms
favorable to us. In addition, any equity financing would result in dilution to stockholders.
Since our revenues are generated in U.S. dollars but a significant portion of our expenses may be incurred in foreign currencies, our
earnings may be reduced due to currency exchange rate fluctuations.
Our revenues are generated in U.S. dollars, while a significant portion of our expenses may be incurred in foreign currencies,
principally the payments to our primary manufacturer that are paid in euros. The exchange rates between the U.S. dollar and other
currencies fluctuate and are affected by, among other things, changes in political and economic conditions. Any significant fluctuation in
the exchange rate for these currencies may materially and adversely affect our earnings, cash flows and financial condition.
If we are unable to manage our infrastructure growth, our business results may be materially and adversely affected.
We need to manage our infrastructure growth to support and maximize our potential revenue growth and achieve our expected
business results. Engaging the full capacity of our limited staff may place a significant strain on our management, operations, and
accounting and information systems. We expect that we will need to continue to improve our financial controls, operating procedures and
management information systems. The failure to manage our infrastructure growth could adversely affect our business results.
If we are not able to implement our business objectives, our operations and financial performance may be adversely affected.
Our principal objectives are to: (i) create a sales platform through marketing products containing our proprietary ingredient
Fortetropin in established, growing, and new markets and strategic selection of partnerships and collaborations to maximize near-term and
future revenues, (ii) deepen the scientific understanding of the activity of Fortetropin, specifically as a natural, reversible, temporary
modulator of the regulatory protein myostatin, and to leverage this knowledge to strengthen and build our intellectual property, (iii) conduct
research and development activities to evaluate myostatin modulation in a range of both wellness and disease states, (iv) identify other
products and technologies which may broaden our portfolio and define a business development strategy to protect, enhance and accelerate
the growth of our products, (v) reduce the cost of manufacturing through process improvement, and (vi) identify contract manufacturing
resources that can fully meet our future growth requirements. Our business plan is based on circumstances currently prevailing and
assumptions that certain circumstances will or will not occur as well as the inherent risk and uncertainties involved in various stages of
development. However, there is no assurance that we will be successful in achieving our objectives. If we are not able to achieve our
objectives, our business operations and financial performance may be adversely affected.
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If we lose the services of our key personnel, we may be unable to replace them, and our business, financial condition and results of
operations could be adversely affected.
Our success largely depends on the continued skills, experience, efforts and policies of our management, directors and other key
personnel and our ability to continue to attract, motivate and retain highly qualified employees. In particular, certain of our directors,
including Dr. Robert Hariri and Dr. Louis Aronne have significant research and development experience and are integral to the creation of
our future products and the execution of our business strategy. In addition, our prospects depend substantially on the services of our
executive management team.
If one or more of our key employees or directors leaves us, we will need to find a replacement with the combination of skills and
attributes necessary to execute our strategy. Because competition for skilled personnel is intense, and the process of finding qualified
individuals can be lengthy and expensive, we believe that the loss of the services of key personnel could adversely affect our business,
financial condition and results of operations. We cannot assure you that we will continue to retain such personnel.
Our success depends on our ability to anticipate and respond in a timely manner to changing consumer demands.
Our success depends on the appeal of our current and future products to a broad range of consumers whose preferences cannot be
predicted with certainty and are subject to change. If our current and future products do not meet consumer demands, our sales may decline.
In addition, our growth depends upon our ability to develop new products through product line extensions and product modifications, which
involve numerous risks. We may not be able to accurately identify consumer preferences, translate our knowledge into customer accepted
products, establish the appropriate pricing for our products or successfully integrate these products with our existing product platform or
operations. We may also experience increased expenses incurred in connection with product development, marketing and advertising that
are not subsequently supported by a sufficient level of sales, which would negatively affect our margins. Furthermore, product development
may divert management’s attention from other business concerns, which could cause sales of our existing products to suffer. We cannot
assure you that newly developed products will contribute favorably to our operating results.
Products often have to be promoted heavily in stores or in the media to obtain visibility and consumer acceptance. Acquiring
distribution for products is difficult and often expensive due to slotting and other promotional charges mandated by retailers. Products can
take substantial periods of time to develop consumer awareness, consumer acceptance and sales volume. Accordingly, some products may
fail to gain or maintain sufficient sales volume and as a result may have to be discontinued.
If our current or future products fail to properly perform, our business could suffer due to increased costs and reduced income.
Failure of our current or future products to meet consumer expectations could result in decreased sales, delayed market acceptance of our
products, increased accounts receivable, unsaleable inventory and customer returns, and divert our resources to reformulation or alternative
products.
Intense competition from existing and new entities may adversely affect our revenues and profitability .
We face competitors that will attempt to create, or are already creating, products that are similar to our current and future products.
Many of our current and potential competitors have significantly longer operating histories and significantly greater managerial, financial,
marketing, technical and other competitive resources, as well as greater name recognition, than we do. These competitors may be able to
respond more quickly to new or changing opportunities and customer requirements and may be able to undertake more extensive
promotional activities, offer more attractive terms to customers or adopt more aggressive pricing policies. We cannot assure you that we
will be able to compete effectively with current or future competitors or that the competitive pressures we face will not harm our business.
Our business is dependent on continually developing or acquiring new and advanced products and processes and our failure to do so
may cause us to lose our competitiveness and may adversely affect our operating results.
To remain competitive in our industry, we believe it is important to continually develop new and advanced products and processes.
There is no assurance that competitive new products and processes will not render our existing or new products obsolete or non-
competitive. Our competitiveness in the marketplace relies upon our ability to continuously enhance our current products, introduce new
products, and develop and implement new technologies and processes. Our failure to evolve and/or develop new or enhanced products may
cause us to lose our competitiveness in the marketplace and adversely affect our operating results.
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Adverse publicity or consumer perception of our products and any similar products distributed by others could harm our reputation and
adversely affect our sales and revenues.
We are highly dependent upon positive consumer perceptions of the safety, efficacy and quality of our products as well as similar
products distributed by our competitors. Consumer perception of dietary supplements and our products in particular can be substantially
influenced by scientific research or findings, national media attention and other publicity about product use. Adverse publicity from such
sources regarding the safety, efficacy or quality of dietary supplements, in general, and our products in particular, could harm our
reputation and results of operations. The mere publication of reports asserting that such products may be harmful or questioning their
efficacy could have a material adverse effect on our business, financial condition and results of operations, regardless of whether such
reports are scientifically supported or whether the claimed harmful effects would be present at the dosages recommended for such products.
Marketing of our products through social media and other advertising methods could harm our business and reputation.
There are many considerations that can affect the marketing and advertising of our products through social media such as claims
and concerns about safety, new discoveries, patent disputes and claims about adverse side effects. Further, claims and concerns about safety
can result in a negative impact on product sales, product recalls or withdrawals, and/or consumer fraud, product liability and other litigation
and claims. A video published online, a blog on the internet, or a post on a website, can be distributed rapidly and negatively harm our
reputation.
Cyberattacks and other security breaches could compromise our proprietary and confidential information as well as our e-commerce
and customer information which could harm our business and reputation.
We generate, collect and store proprietary information, including intellectual property and business information. The secure
storage, maintenance, and transmission of and access to this information is important to our operations and reputation. Computer hackers
may attempt to penetrate our computer systems and, if successful, misappropriate our proprietary and confidential information including e-
mails and other electronic communications. In addition, an employee, contractor, or other third-party with whom we do business may
attempt to obtain such information, and may purposefully or inadvertently cause a breach involving such information. While we have
certain safeguards in place to reduce the risk of and detect cyber-attacks, our information technology networks and infrastructure may be
vulnerable to unpermitted access by hackers or other breaches, or employee error or malfeasance. Any such compromise of our data
security and access to, or public disclosure or loss of, confidential business or proprietary information could disrupt our operations, damage
our reputation, provide our competitors with valuable information, and subject us to additional costs which could adversely affect our
business.
The scientific support for Fortetropin is subject to uncertainty.
Our research, scientific knowledge and clinical testing supporting the benefits of our products are an essential element of our
ability to legally market our products. There is, however, the risk that new or undiscovered information may become available that may
undermine or refute our scientific support. In addition, our clinical testing of Fortetropin has been limited in scope and additional testing
may reveal deficiencies and side effects that we are currently unaware of. A reduction in the credibility of our scientific support for the
effectiveness of Fortetropin could have a material adverse effect on our operations and financial conditions.
If we are required to withdraw our products from the market, change the labeling of our products and/or are subject to product liability
claims, our operations and financial performance may be adversely affected.
There is a potential for any ingested product to result in side effects in certain consumers. Although we are not aware of any
adverse effects of our products on the health of consumers, if any such side effects are identified after marketing and sale of the product, we
may be required to withdraw our products from the market or change its labeling. We may also be required to withdraw our products from
the market as a result of regulatory issues. If we are required to withdraw our products from the market, our business operations and
financial performance may be adversely affected. Furthermore, if a product liability claim is brought against us, it may, regardless of merit
or eventual outcome, result in damage to our reputation, decreased demand for our products, costly litigation and loss of revenue.
An increase in product returns could negatively impact our operating results and profitability.
Historically, sales allowances for product returns have not been provided, since under our existing arrangements, customers are
not permitted to return product except for non-conforming product. In certain instances we may permit the return of damaged or defective
products and accept limited amounts of product returns. While such returns have historically been nominal and within management’s
expectations and the provisions established, future return rates may differ from those experienced in the past. Any significant increase in
damaged or defective products or expected returns could have a material adverse effect on our operating results for the period or periods in
which such returns materialize. With respect to future sales, we may need to offer retail customers sales incentives, including the right to
return product. If those customers are not able to sell our products to end-consumers, significant product returns may materialize, which
could have a material adverse effect on our operating results.
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We are dependent on third-party manufacturers, suppliers and processors to produce our products.
We currently rely on third-party manufacturers, suppliers and processors to produce our products. If our manufacturers, suppliers
or processors are unable to provide us with the required finished products or raw materials or are unable or unwilling to produce sufficient
quantities of our products, our business and revenues will be adversely affected.
A shortage in the supply of, or a price increase in, raw materials could increase our costs or adversely affect our sales and revenues.
All of the raw materials for our products are sourced from third-party suppliers. Currently, we have one primary third-party
manufacturer to produce Fortetropin under a fixed price agreement that runs through December 2018. Any shortages in our raw materials
could adversely affect operations. Price increases from a supplier will affect our profitability if we are not able to pass price increases on to
customers. The inability to obtain adequate supplies of raw materials in a timely manner of our raw materials could have a material adverse
effect on our business, financial condition and results of operations.
While our raw material inventories generally have a long shelf life, we may be required to write-off or reserve for inventories that are
slow-moving, off-grade, damaged or otherwise not saleable. Such write-offs and/or reserves could have a material adverse effect on our
business, financial condition and results of operations.
Our raw material inventories are comprised of dried powder derived from egg-yolk, and despite generally having a long shelf life,
we may be required to write-off or reserve for inventories that are slow-moving, off-grade, damaged or otherwise not saleable. Cost of
sales for the year ended December 31, 2016 and 2015 included slow moving obsolete/damaged goods inventory charges of $106 and $697,
respectively. Future required write-offs or reserves could have a material adverse effect on our business, financial condition and results of
operations.
We have no manufacturing capacity and anticipate continued reliance on third-party manufacturers for the development and
commercialization of our products.
We do not currently operate manufacturing facilities for production of our product. We lack the resources and the capabilities to
manufacture our products on a commercial scale. We do not intend to develop facilities for the manufacture of our products in the
foreseeable future. We rely on third-party manufacturers to produce bulk products required to meet our sales needs. We plan to continue to
rely upon contract manufacturers to manufacture commercial quantities of our products.
Our contract manufacturers’ failure to achieve and maintain high manufacturing standards, in accordance with applicable
regulatory requirements, or the incidence of manufacturing errors, could result in consumer injury or death, product shortages, product
recalls or withdrawals, delays or failures in product testing or delivery, cost overruns or other problems that could seriously harm our
business. Contract manufacturers often encounter difficulties involving production yields, quality control and quality assurance, as well as
shortages of qualified personnel. Our existing manufacturers and any future contract manufacturers may not perform as agreed or may not
remain in the contract manufacturing business. In the event of a natural disaster, business failure, strike or other difficulty, we may be
unable to replace a third-party manufacturer in a timely manner and the production of our products would be interrupted, resulting in
delays, additional costs and reduced revenues.
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Our research and development activities may be costly and/or untimely, and there are no assurances that our research and development
activities will either be successful or completed within the anticipated timeframe, if ever at all.
Research and development activities may be costly and/or untimely, and there are no assurances that our research and
development activities will either be successful or completed within the anticipated timeframe, if at all. The continued research and
development of Fortetropin and our future products is important to our success. In addition, the development of new products requires
significant research, development and testing all of which require significant investment and resources. At this time, our resources are
limited and our research and development activities are dependent upon our ability to fund our activities and to raise capital which may not
be possible. We may enter into agreements with third party vendors to engage in research and development for us. However, the failure of
the third-party researcher to perform under agreements entered into with us, or our failure to renew important research agreements with a
third party, may delay or curtail our research and development efforts. The research and development of new products is costly and time
consuming, and there are no assurances that our research and development activities will be successful. Even if a new product is developed,
there is no assurance that it will be commercialized or result in sales.
We may not be able to protect our intellectual property rights which could cause our assets to lose value.
Our business depends on and will continue to depend on our intellectual property, including our valuable brands and internally-
developed products. We believe our intellectual property rights are important to our continued success and our competitive position.
However, we may be unable or unwilling to strictly enforce our intellectual property rights, including our patents and trademarks, from
infringement due to the substantial costs of such enforcement. In addition, while there are patent applications pending for our core product,
there is no assurance that such applications will issue as patents. Our failure to enforce our intellectual property rights could diminish the
value of our brands and product offerings and harm our business and future growth prospects.
In addition, unauthorized parties may attempt to copy or otherwise obtain and use our services, technology and other intellectual
property, and we cannot be certain that the steps we have taken to protect our proprietary rights will prevent any misappropriation or
confusion among consumers and merchants, or unauthorized use of these rights. Advancements in technology have exacerbated the risk by
making it easier to duplicate and disseminate intellectual property. In addition, as our business becomes more global in scope, we may not
be able to protect our proprietary rights in a cost-effective manner in a multitude of jurisdictions with varying laws. If we are unable to
procure, protect and enforce our intellectual property rights, we may not realize the full value of these assets, and our business may suffer.
If we need to commence litigation to enforce our intellectual property rights or determine the validity and scope of the proprietary rights of
others, such litigation may be costly and divert the attention of our management.
We may be subject to intellectual property rights claims, which are costly to defend, could require us to pay damages and could limit our
ability to sell some of our products.
We may become subject to intellectual property litigation or infringement claims, which could cause us to incur significant
expenses to defend such claims, divert management’s attention or prevent us from manufacturing, importing, selling or using some aspect
of our current or future products. If we choose or are forced to settle such claims, we may be required to pay for a license to certain rights,
pay royalties on both a retrospective and prospective basis, and/or cease manufacturing importing and selling certain infringing products.
Future infringement claims against us by third parties may adversely impact our business, financial condition and results of operations.
In addition, our primary third-party manufacturer assigned its United States patent application for making Fortetropin, the key
ingredient in our products, to us in exchange for royalty payments for each kilogram of Fortetropin that we produce, for a period of seven
years from the expiration date of the supply agreement on December 31, 2016. Subsequent to the assignment of the patent application, in
August 2014, the USPTO issued to us U.S. Patent No. 8,815,320 B2 covering the proprietary methods of manufacturing Fortetropin.
Our advertising and marketing efforts may be costly and may not achieve desired results.
We intend to incur substantial expenses in connection with our advertising and marketing efforts for our products. Although we
intend to target our advertising and marketing efforts on current and potential customers who we believe are likely to be in the market for
the products we sell, we cannot assure you that our advertising and marketing efforts will achieve our desired results. We will periodically
adjust our advertising expenditures in an effort to optimize the return on such expenditures knowing that any such decrease we make to
optimize such return could adversely affect our sales.
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We rely on independent shipping companies to deliver the products we sell.
We rely upon third party carriers, especially FedEx and UPS, for timely delivery of our product shipments. As a result, we are
subject to carrier disruptions and increased costs due to factors that are beyond our control, including employee strikes, inclement weather
and increased fuel costs. Any failure to deliver products to our customers in a timely and accurate manner may damage our reputation and
brand and could cause us to lose customers. We do not have a written long-term agreement with any of these third party carriers, and we
cannot be sure that these relationships will continue on terms favorable to us, if at all. If our relationship with any of these third party
carriers is terminated or impaired, or if any of these third parties are unable to deliver products for us, we would be required to use
alternatives for shipment of products to our customers. We may be unable to engage alternative carriers on a timely basis or on terms
favorable to us, if at all. Potential adverse consequences include:
● reduced visibility of order status and package tracking;
● delays in order processing and product delivery;
● increased cost of delivery, resulting in reduced margins; and
● reduced shipment quality, which may result in damaged products and customer dissatisfaction.
Furthermore, shipping costs represent a significant operational expense for us. Any future increases in shipping rates could have a
material adverse effect on our business, financial condition and results of operations.
We rely on fulfillment centers to package and deliver our product to customers who place orders online
We have an agreement with one fulfillment center to box and ship our products to customers once an order has been placed. We
cannot be sure that our relationship with the fulfillment center will continue on terms favorable to us, if at all. If our relationship with them
is terminated or impaired, or if they are unable to deliver products for us, we would be required to use alternatives for shipment of products
to our customers.
We face significant inventory risk.
We are exposed to significant inventory risks that may adversely affect our operating results as a result of new product launches,
rapid changes in product cycles and pricing, defective merchandise, changes in consumer demand and consumer spending patterns,
changes in consumer tastes with respect to our products, and other factors. We endeavor to accurately predict these trends and avoid
overstocking or understocking our products. Demand for products, however, can change significantly between the time inventory is ordered
and the date of sale. In addition, when we begin selling or manufacturing a new product, it may be difficult to determine appropriate
product selection, and accurately forecast demand. The acquisition of inventory may require significant lead-time and prepayment and we
may be unable to sell products in sufficient quantities or during the relevant selling seasons. Any one of these risks may adversely affect
our operating results.
Our failure to respond appropriately to competitive challenges, changing consumer preferences and demand for new products could
significantly harm our customer relationships and product sales.
The nutritional supplement industry is characterized by intense competition for product offerings and rapid and frequent changes
in consumer demand. Our failure to predict accurately product trends could negatively impact our products and cause our revenues to
decline.
Our success with any particular product offering (whether new or existing) depends upon a number of factors, including our
ability to:
● deliver quality products in a timely manner in sufficient volumes;
● accurately anticipate customer needs and forecast accurately to our manufacturers;
● differentiate our product offerings from those of our competitors;
● competitively price our products; and
● develop new products.
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Furthermore, products often have to be promoted heavily in stores or in the media to obtain visibility and consumer acceptance.
Acquiring distribution for products is difficult and often expensive due to slotting and other promotional charges mandated by retailers.
Products can take substantial periods of time to develop consumer awareness, consumer acceptance and sales volume. Accordingly, some
products may fail to gain or maintain sufficient sales volume and as a result may have to be discontinued.
Our industry is highly competitive, and our failure to compete effectively could adversely affect our market share, financial condition
and future growth.
The nutritional supplement industry is highly competitive with respect to:
● price;
● shelf space and store placement;
● brand and product recognition;
● product introductions; and
● raw materials.
Most of our competitors are larger, more established companies and possess greater financial strength, personnel, distribution and
other resources than we have. We face competition in the supplement market from a number of large nationally known manufacturers,
private label brands and many smaller manufacturers.
Adverse publicity or consumer perception of our products and any similar products distributed by others could harm our reputation and
adversely affect our sales.
We believe we are highly dependent upon positive consumer perceptions of the safety and quality of our products as well as
similar products distributed by other nutritional supplement companies. Consumer perception of nutritional supplements and our products in
particular can be substantially influenced by scientific research or findings, national media attention and other publicity about product use.
Adverse publicity from these sources regarding the safety, quality or efficacy of nutritional supplements and our products could harm our
reputation and results of operations. The mere publication of news articles or reports asserting that such products may be harmful or
questioning their efficacy could have a material adverse effect on our business, financial condition and results of operations, regardless of
whether such news articles or reports are scientifically supported or whether the claimed harmful effects would be present at the dosages
recommended for such products.
Changes in the economies of the markets in which we do business may affect consumer demand for our products.
Consumer spending habits, including spending for our products, are affected by, among other things, prevailing economic
conditions, levels of employment, fuel prices, changes in exchange rates, salaries and wages, the availability of consumer credit, consumer
confidence and consumer perception of economic conditions. Economic slowdowns in the markets in which we do business and an
uncertain economic outlook may adversely affect consumer spending habits, which may result in lower sales of our products in future
periods. A prolonged global or regional economic downturn could have a material negative impact on our financial position, results of
operation or cash flows.
Our insurance coverage may be insufficient to cover our legal claims or other losses that we may incur in the future.
We maintain insurance, including property, general and product liability and other forms of insurance to protect ourselves against
potential loss exposures. In the future, insurance coverage may not be available at adequate levels or on adequate terms to cover potential
losses. If insurance coverage is inadequate or unavailable, we may face claims that exceed coverage limits or that are not covered, which
could increase our costs and adversely affect our operating results.
We may be subject to uncertain and costly compliance with government regulations.
The importing, manufacturing, processing, formulating, packaging, labeling, distributing, selling and advertising of our current and
future products may be subject to regulation by one or more federal or state agencies. The Food and Drug Administration, or the FDA, has
primary jurisdiction over our products pursuant to the Federal Food, Drug and Cosmetic Act, as amended by the Dietary Supplement and
Health Education Act, or the FDCA, and regulations promulgated thereunder. The FDCA provides the regulatory framework for the safety
and labeling of dietary supplements, foods and medical foods. In particular, the FDA regulates the safety, manufacturing, labeling and
distribution of dietary supplements. In addition, the Animal Plant Health and Inspection Service, or APHIS, regulates the importation of our
primary product from Germany. The Federal Trade Commission, or the FTC, and the FDA share jurisdiction over the promotion and
advertising of dietary supplements. Pursuant to a memorandum of understanding between the two agencies, the FDA has primary
jurisdiction over claims that appear on product labels and labeling and the FTC has primary jurisdiction over product advertising.
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Compliance with applicable federal, state, and local laws and regulations is a critical part of our business. We endeavor to comply
with all applicable laws and regulations. However, as with any regulated industry, the laws and regulations are subject to interpretation and
there can be no assurances that a government agency would necessarily agree with our interpretation of the governing laws and regulations.
Moreover, we are unable to predict the nature of such future laws, regulations, interpretations or applications, nor can we predict what
effect additional governmental regulations or administrative orders, when and if promulgated, would have on our business in the future.
These regulations could, however, require the reformulation of our products to meet new standards, market withdrawal or discontinuation
of certain products not able to be reformulated. The risk of a product recall exists within the industry although we endeavor to minimize the
risk of recalls by distributing products that are not adulterated or misbranded. However, the decision to initiate a recall is often made for
business reasons in order to avoid confrontation with FDA.
Our products are required to be prepared in compliance with the FDA’s GMPs, for dietary supplements. Fortetropin, the main
ingredient in our products, is also required to be imported into the United States in conformance with APHIS’s requirements for egg
products. In the event it is determined that we have not complied with the foregoing requirements, we may be required to initiate a product
recall and/or be subject to financial or other penalties. We are continuously monitoring and reviewing our processes to ensure compliance
with APHIS and limit the likelihood of potential recalls.
Other statutory obligations include reporting all serious adverse events on a Medwatch Form 3500A. To date, we have not filed a
Medwatch Form 3500A with the FDA nor have we been placed on notice regarding any serious adverse events related to any of our
products. Since eggs are considered a major food allergen under the Food Allergen Labeling and Consumer Protection Act of 2004, the
labeling of all our products must note that they contain egg product.
Advertising of dietary supplement products is subject to regulation by the FTC under the Federal Trade Commission Act, or
FTCA, which prohibits unfair methods of competition and unfair or deceptive trade acts or practices in or affecting commerce. The FTCA
provides that the dissemination of any false advertising pertaining to foods, including dietary supplements, is an unfair or deceptive act or
practice. Under the FTC's substantiation doctrine, an advertiser is required to have a reasonable basis for all objective product claims before
the claims are made. All advertising is required to be truthful and not misleading. All testimonials are required to be typical of the results
the consumer may expect when using the product as directed. Accordingly, we are required to have adequate substantiation of all material
advertising claims made for our products. Failure to adequately substantiate claims may be considered either deceptive or unfair practices.
We cannot predict what effect additional domestic or international governmental legislation, regulations, or administrative orders,
when and if promulgated, would have on our business in the future. New legislation or regulations may require the reformulation of certain
products to meet new standards, require the recall or discontinuance of certain products not capable of reformulation, impose additional
record keeping or require expanded documentation of the properties of certain products, expanded or different labeling or scientific
substantiation.
RISKS RELATED TO OUR COMMON STOCK
Trading in our common stock over the last 12 months has fluctuated, so investors may not be able to sell as many of their shares as they
want at prevailing prices.
Our common stock is listed on the Nasdaq Capital Market. There has been an increase in trading of our shares over the last 12
months, but it still may be difficult for investors to sell such shares in the public market at any given time as prices have fluctuated.
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Our common stock may be delisted from the Nasdaq Capital Market if we cannot satisfy its continued listing requirements.
Among the conditions required for continued listing on the Nasdaq Capital Market is that we maintain at least $2.5 million in
stockholders’ equity. There can be no assurance that our stockholders’ equity will remain above the $2.5 million minimum. If we fail to
timely comply with the stockholders’ equity requirement, our common stock may be delisted from the Nasdaq Capital Market. In addition,
even if we demonstrate compliance with the stockholders’ equity requirement, we will need to continue to meet other objective and
subjective listing requirements to continue to be listed on the Nasdaq Capital Market. Delisting from the Nasdaq Capital Market could
make trading our common stock more difficult for investors, potentially leading to declines in our share price and liquidity. Without a
Nasdaq Capital Market listing, stockholders may have a difficult time getting a quote for the sale or purchase of our common stock, the
sale or purchase of our common stock would likely be made more difficult and the trading volume and liquidity of our stock could decline.
Delisting from the Nasdaq Capital Market could also result in negative publicity and could also make it more difficult for us to raise
additional capital. The absence of such a listing may adversely affect the acceptance of our common stock as currency or the value
accorded by other parties. Further, if we are delisted, we would be required to incur additional costs under state blue sky laws in connection
with any sales of our securities. These requirements could severely limit the market liquidity of our common stock and the ability of our
stockholders to sell our common stock in the secondary market. If our common stock is delisted from the Nasdaq Capital Market, our
common stock may be eligible to trade on an over-the-counter quotation system, such as the OTCQB market, where an investor may find it
more difficult to sell our stock or obtain accurate quotations as to the market value of our common stock. We cannot assure you that our
common stock, if delisted from the Nasdaq Capital Market, will be listed on another national securities exchange or quoted on an over-the-
counter quotation system.
If the Nasdaq Capital Market delists our shares of common stock from trading on its exchange and we are not able to list our securities
on another national securities exchange, we expect our securities could be quoted on an over-the-counter market. If this were to occur,
we could face significant material adverse consequences, including:
● a limited availability of market quotations for our securities;
● reduced liquidity for our shares;
● a determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere to more
stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our shares;
● a limited amount of news and analyst coverage; and
● a decreased ability to issue additional securities or obtain additional financing in the future.
An active and visible trading market for our common stock may not develop.
We cannot predict whether an active market for our common stock will develop in the future. In the absence of an active trading
market:
● investors may have difficulty buying and selling or obtaining market quotations;
● market visibility for our common stock may be limited; and
● a lack of visibility for our common stock may have a depressive effect on the market price for our common stock.
The trading price of our common stock is expected to be subject to significant fluctuations in response to variations in quarterly
operating results, changes in analysts’ earnings estimates, announcements of innovations by us or our competitors, general conditions in the
industry in which we operate and other factors. These fluctuations, as well as general economic and market conditions, may have a material
or adverse effect on the market price of our common stock.
The market price for our stock may be volatile.
The market price for our stock may be volatile and subject to wide fluctuations in response to factors including the following:
● actual or anticipated fluctuations in our quarterly operating results;
● changes in financial estimates by securities research analysts;
● conditions in nutritional supplement and pharmaceutical markets;
● changes in the economic performance or market valuations of other nutritional supplement companies;
● announcements by us or our competitors of new products, acquisitions, strategic partnerships, joint ventures or capital
commitments;
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● addition or departure of key personnel;
● intellectual property or other litigation; and
● general economic or political conditions.
In addition, the securities market has from time to time experienced significant price and volume fluctuations that are not related to
the operating performance of particular companies. These market fluctuations may also materially and adversely affect the market price of
our stock.
Our stockholders may experience significant dilution if future equity offerings are used to fund operations or acquire complementary
businesses or as a result of the issuance of a substantial number of shares of common stock upon the exercise of outstanding options
and warrants.
If our future operations or acquisitions are financed through the issuance of equity securities, our stockholders could experience
significant dilution. In addition, securities issued in connection with future financing activities or potential acquisitions may have rights and
preferences senior to the rights and preferences of our common stock. We have also reserved 850,000 shares of our common stock under an
equity incentive plan for our directors, officers, employees, consultants and advisors and granted options to purchase shares of our common
stock under the plan. The issuance of shares of our common stock upon the exercise of these options as well as upon the exercise of
outstanding warrants to purchase up to 821,202 shares of our common stock, which includes a warrant to purchase 375,000 shares of
common stock issued to RENS Technology Inc. in connection with the first tranche of the Financing, may result in significant dilution to
our stockholders.
Mr. Ren can exert significant influence over us and make decisions that are not in the best interests of all stockholders.
Mr. Ren and his affiliates currently beneficially own approximately 32% of our outstanding shares of common stock. As a result,
he will be able to assert significant influence over all matters requiring stockholder approval, including the election and removal of directors
and any change in control. In particular, this concentration of ownership of our outstanding shares of common stock could have the effect of
delaying or preventing a change in control, or otherwise discouraging or preventing a potential acquirer from attempting to obtain control.
This, in turn, could have a negative effect on the market price of our common stock. It could also prevent our stockholders from realizing a
premium over the market prices for their shares of common stock. Moreover, the interests of the owners of this concentration of ownership
may not always coincide with our interests or the interests of other stockholders and, accordingly, could cause us to enter into transactions
or agreements that we would not otherwise consider.
Compliance with changing corporate governance regulations and public disclosure, and our management’s inexperience with such
regulations, will result in additional expenses and creates a risk of non-compliance.
Our reporting obligations as a public company will place a significant strain on our management, operational and financial
resources and systems for the foreseeable future. Changing laws, regulations and standards relating to corporate governance and public
disclosure, including the Sarbanes-Oxley Act of 2002 and related SEC regulations, have created uncertainty for public companies and
significantly increased the costs and risks associated with accessing the public markets and public reporting. Our management team will
need to invest significant time and financial resources to comply with both existing and evolving standards for public companies, which will
lead to increased general and administrative expenses and a diversion of management time and attention from revenue generating activities
to compliance activities.
We do not foresee paying cash dividends in the foreseeable future and, as a result, our investors’ sole source of gain, if any, will depend
on capital appreciation, if any.
We do not plan to declare or pay any cash dividends on our shares of common stock in the foreseeable future and currently intend
to retain any future earnings for funding growth. As a result, investors should not rely on an investment in our securities if they require the
investment to produce dividend income. Capital appreciation, if any, of our shares may be investors’ sole source of gain for the foreseeable
future. Moreover, investors may not be able to resell their common stock at or above the price they paid for them.
28
Provisions in our charter documents, the shareholder rights plan we have adopted, and under Nevada law could discourage a takeover
that stockholders may consider favorable.
Our articles of incorporation provides for the authorization to issue up to 500,000 shares of blank check preferred stock with
designations, rights and preferences as may be determined from time to time by our board of directors. Our board of directors is
empowered, without stockholder approval, to issue a series of preferred stock with dividend, liquidation, conversion, voting or other rights
which could dilute the interest of, or impair the voting power of, our common stockholders. The issuance of a series of preferred stock
could be used as a method of discouraging, delaying or preventing a change in control. For example, it would be possible for our board of
directors to issue preferred stock with voting or other rights or preferences that could impede the success of any attempt to change control
of our company. In addition, we have a classified board of directors that consists of three groups, which may increase the length of time
necessary for an acquirer to change the composition of a majority of directors to gain control of our board of directors.
We have also adopted a shareholder rights plan that could make it more difficult for a third party to acquire, or could discourage a
third party from acquiring, us or a large block of our common stock. A third party that acquires 10% or more of our common stock could
suffer substantial dilution of its ownership interest under the terms of the shareholder rights plan through the issuance of our shares to all
stockholders other than the acquiring person. These and other provisions in our articles of incorporation and bylaws could make it more
difficult for stockholders or potential acquirers to obtain control of our board of directors or initiate actions that are opposed by our then-
current board of directors, including a merger, tender offer, or proxy contest involving our company. Any delay or prevention of a change
of control transaction or changes in our board of directors could cause the market price of our common stock to decline.
Provisions of Nevada corporate law limit the personal liability of corporate directors and officers and require indemnification under
certain circumstances.
Section 78.138(7) of the Nevada Revised Statutes provides that, subject to certain very limited statutory exceptions or unless the
articles of incorporation provide for greater individual liability, a director or officer of a Nevada corporation is not individually liable to the
corporation or its stockholders for any damages as a result of any act or failure to act in his or her capacity as a director or officer, unless it
is proven that the act or failure to act constituted a breach of his or her fiduciary duties as a director or officer and such breach involved
intentional misconduct, fraud or a knowing violation of law. We have not included in our articles of incorporation any provision intended to
provide for greater liability as contemplated by this statutory provision.
In addition, Section 78.7502(3) of the Nevada Revised Statutes provides that to the extent a director or officer of a Nevada
corporation has been successful on the merits or otherwise in the defense of certain actions, suits or proceedings (which may include
certain stockholder derivative actions), the corporation shall indemnify such director or officer against expenses (including attorneys’ fees)
actually and reasonably incurred by such director or officer in connection therewith.
If securities or industry analysts do not publish research or reports about our business, or if they change their recommendations
regarding our stock adversely, our stock price and trading volume could decline.
The trading market for our common stock will be influenced by the research and reports that industry or securities analysts publish
about us or our business. We do not currently have and may never obtain significant research coverage by industry or financial analysts. If
few analysts commence coverage of us, the trading price of our stock would likely decrease. Even if we do obtain significant analyst
coverage, if one or more of the analysts who cover us downgrade our stock, our stock price would likely decline. If one or more of these
analysts cease coverage of us or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could
cause our stock price or trading volume to decline.
A failure of our internal control over financial reporting could materially impact our business or share price.
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. An internal
control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the objectives of the
control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of
controls must be considered relative to their costs. Because of the inherent limitations in all internal control systems, internal control over
financial reporting may not prevent or detect misstatements. Any failure to maintain an effective system of internal control over financial
reporting could limit our ability to report our financial results accurately and timely or to detect and prevent fraud, and could expose us to
litigation or adversely affect the market price of our common stock.
29
RISKS RELATED TO OUR FUTURE PRODUCTS
The research and development of pharmaceutical products, which is separate from nutritional supplements, entails special
considerations and risks. If we are successful in developing pharmaceutical products for muscular-related conditions, we will be subject to,
and possibly adversely affected by, the following risks:
Our failure to obtain costly government approvals, including required FDA approvals, or to comply with ongoing governmental
regulations relating to our technologies and proposed products and formulations could delay or limit introduction of our proposed
formulations and products and result in failure to achieve revenues or maintain our ongoing business.
Our research and development activities for our products and product candidates are currently at an early development stage and
are subject to extensive regulation for safety, efficacy and quality by numerous government authorities in the United States and abroad.
Before receiving FDA regulatory clearance to market our future proposed formulations and products, we will have to demonstrate that our
formulations and products are safe and effective in the patient population and for the indicated diseases that are to be treated. Clinical trials,
manufacturing and marketing of drugs are subject to the rigorous testing and approval process of the FDA and equivalent foreign
regulatory authorities. The Federal Food, Drug and Cosmetic Act and other federal, state and foreign statutes and regulations govern and
influence the testing, manufacture, labeling, advertising, distribution and promotion of drugs and medical devices. As a result, regulatory
approvals can take a number of years or longer to accomplish and require the expenditure of substantial financial, managerial and other
resources.
Conducting and completing the clinical trials necessary for FDA approval is costly and subject to intense regulatory scrutiny as well as
the risk of failing to meet the primary endpoint of such trials. We will not be able to commercialize and sell our future products and
formulations without successfully completing such trials.
In order to conduct clinical trials that are necessary to obtain approval by the FDA to market a formulation or product, it is
necessary to receive clearance from the FDA to conduct such clinical trials. The FDA can halt clinical trials at any time for safety reasons
or because we or our clinical investigators did not follow the FDA’s requirements for conducting clinical trials. If we are unable to receive
clearance to conduct clinical trials or the trials are permanently halted by the FDA, we would not be able to achieve any revenue from such
product as it is illegal to sell any drug or medical device for human consumption or use without FDA approval.
Data obtained from clinical trials are susceptible to varying interpretations, which could delay, limit or prevent regulatory clearances.
Data we may obtain in the future, from non-clinical studies and clinical trials do not necessarily predict the results that will be
obtained from later non-clinical studies and clinical trials. Moreover, non-clinical and clinical data are susceptible to multiple and varying
interpretations, which could delay, limit or prevent regulatory approval. A number of companies in the pharmaceutical industry have
suffered significant setbacks in advanced clinical trials, even after promising results in earlier trials. The failure to adequately demonstrate
the safety and effectiveness of a proposed formulation or product under development could delay or prevent regulatory clearance of the
product candidate, resulting in delays to commercialization, and could materially harm our business. In addition, our clinical trials may not
demonstrate sufficient levels of safety and efficacy necessary to obtain the requisite regulatory approvals for our drugs, and thus our
proposed drugs may not be approved for marketing. Finally, if any of our clinical trials do not meet their primary endpoints, we would need
to redo such clinical trials in order to progress development of the subject product. These additional trials would be costly and divert
resources from other projects.
Competitors may develop competing technologies or products which outperform or supplant our technologies or products.
Drug companies and/or other technology companies may in the future seek to develop and market pharmaceutical products which
may compete with our future technologies and products. Competitors may in the future develop similar or different technologies or
products which may become more accepted by the marketplace or which may supplant our technology entirely. In addition, many of our
future competitors may be significantly larger and better financed than we are, thus giving them a significant advantage over us.
We may be unable to respond to competitive forces presently in the marketplace (including competition from larger companies),
which would severely impact our business. Moreover, should competing or dominating technologies or products come into existence and
the owners thereof patent the applicable technological advances, we could also be required to license such technologies in order to continue
to manufacture, market and sell our products. We may be unable to secure such licenses on commercially acceptable terms, or at all, and
our resulting inability to manufacture, market and sell the affected products could have a material adverse effect on us.
30
The market for our product candidates is rapidly changing and competitive, and new drug delivery mechanisms, drug delivery
technologies, new drugs and new treatments which may be developed by others could impair our ability to maintain and grow our
business and remain competitive.
Even if successfully developed, our product candidates may not gain market acceptance among physicians, patients and healthcare
payers, which may not utilize our products. If our product candidates do not achieve market acceptance, our business and financial
condition will be materially adversely affected. The pharmaceutical industry is subject to rapid and substantial technological change.
Developments by others may render our technologies and our product candidates noncompetitive or obsolete, or we may be unable to keep
pace with technological developments or other market factors. Technological competition from pharmaceutical and biotechnology
companies, universities, governmental entities and others now existing or diversifying into the field is intense and is expected to increase.
Many of these entities have significantly greater research and development capabilities, human resources and budgets than we do, as well
as substantially more marketing, manufacturing, financial and managerial resources. These entities represent significant competition for us.
Acquisitions of, or investments in, competing pharmaceutical or biotechnology companies by large corporations could increase such
competitors’ financial, marketing, manufacturing and other resources.
Item 1B. Unresolved Staff Comments.
Not applicable.
Item 2.
Properties.
We do not own any real estate or other physical properties materially important to our operation. Our executive office is located at
45 Horsehill Road, Suite 106, Cedar Knolls, New Jersey 07927. Our office space consists of 5,225 square feet. The lease expires on
December 31, 2019. We have two options to renew our lease for an additional three years each. We consider our current office space
adequate for our current operations. For additional information refer to Part IV, Item 15, “Notes to Consolidated Financial Statements: Note
12 – Commitments and Contingencies.”
Item 3.
Legal Proceedings.
On October 27, 2016, Cutler Holdings, L.L.C. (“Cutler”) filed a complaint in the Superior Court of New Jersey alleging that the
Company failed to make certain rental payments. On March 30, 2017, the Company entered into a settlement agreement with Cutler,
pursuant to which Cutler released the Company from any liability for the claims asserted in the complaint.
On January 6, 2017, the Company commenced an action in the Supreme Court of New York, County of New York, against RENS
Technology, Inc. (“the Purchaser”), RENS Agriculture, the parent company of the Purchaser, and Ren Ren, a principal in both entities and a
director of the Company, arising from the Purchaser’s breach of a Securities Purchase Agreement under which the Purchaser agreed to
invest an aggregate of $20.25 million in the Company in exchange for an aggregate of 3,537,037 shares of common stock of the Company
and warrants to purchase an aggregate of 884,259 shares of common stock. In addition to seeking compensatory, consequential and other
damages in the action, the Company asked the Court to preliminarily restrain the Purchaser and its agents and representatives, including,
but not limited to, RENS Agriculture and Ren Ren, from selling, transferring, conveying, assigning, hypothecating or encumbering
1,500,000 shares of common stock of the Company and a warrant permitting the purchase of 375,000 share at a price of $7.00 per share
that the Purchaser had purchased under the Securities Purchase Agreement and, after the parties had an opportunity to submit opposition
and reply papers in connection with the Company’s application, a preliminary injunction prohibiting the Purchaser from selling,
transferring, conveying, assigning, hypothecating or encumbering the 1,500,000 shares and warrant during the pendency of the action and
an order attaching the stock and warrant to satisfy any judgment entered in favor of the Company.
On January 11, 2017, the Court granted the Company the preliminary restraints that it requested, which prevents RENS
Technology, among others, from selling, transferring, conveying, assigning, hypothecating or encumbering the 1,500,000 shares of the
Company’s common stock or the aforementioned warrant. The Court scheduled a hearing on February 14, 2017, at which time the Court
heard oral argument on the application for a preliminary injunction and prejudgment attachment of the stock and warrants to satisfy any
judgment entered in favor of the Company. Since then, RENS Technology filed a motion to dismiss the complaint which the Company has
opposed. No decision has been made by the Court on these two pending applications.
Item 4.
Mine Safety Disclosures.
None.
31
PART II
Item 5.
Market for Registrant’s Common Equity and Related Stockholder Matters and Issuer Purchases of Equity Securities.
(a) Market Information
Our common stock is listed on the Nasdaq Capital Market under the symbol “MYOS.” The following table sets forth, for the
periods indicated, the high and low bid prices for shares of our common stock as reported on the Nasdaq Capital Market:
Period
October 1, 2016 through December 31, 2016
July 1, 2016 through September 30, 2016
April 1, 2016 through June 30, 2016
January 1, 2016 through March 31, 2016
October 1, 2015 through December 31, 2015
July 1, 2015 through September 30, 2015
April 1, 2015 through June 30, 2015
January 1, 2015 through March 31, 2015
High
Low
1.80 $
2.28 $
2.94 $
2.40 $
4.40 $
3.70 $
7.50 $
7.36 $
1.12
1.35
1.23
1.23
1.36
1.50
3.05
4.30
$
$
$
$
$
$
$
$
These bid prices were obtained from the Nasdaq Capital Market and do not necessarily reflect actual transactions, retail markups,
mark downs or commissions.
As of March 30, 2017, the last reported sales price of our shares on the NASDAQ Capital Market was $2.88.
(b) Holders
The Company had approximately 129 record holders of the common stock as of March 30, 2017. This does not include an
indeterminate number of stockholders whose shares may be held by brokers in street name. The holders of common stock are entitled to
one vote for each share held of record on all matters submitted to a vote of stockholders. Holders of the common stock have no preemptive
rights and no right to convert their common stock into any other securities. There are no redemption or sinking fund provisions applicable
to the common stock.
Our independent stock transfer agent is Island Stock Transfer which is located at 15500 Roosevelt Boulevard, Suite 301,
Clearwater, Florida 33760.
(c) Dividends
We have never declared or paid any cash dividends on our capital stock. We currently intend to retain future earnings, if any, for
development of our business and therefore do not anticipate that we will declare or pay cash dividends on our capital stock in the
foreseeable future.
32
(d) Securities Authorized for Issuance under Equity Compensation Plans
The following table indicates shares of common stock authorized for issuance under equity incentive plans as of December 31,
2016:
Plan category
Equity compensation plans approved by security holders
Equity compensation plans not approved by security holders
Total
Number of
securities to be
issued upon
exercise of
outstanding
options,
warrants and
rights
(a)
Weighted-
average exercise
price of
outstanding
options, warrants
and rights
(b)
Number of
securities
remaining
available for
future issuance
(c)
270,340(1) $
30,000(2) $
$
300,340
13.58
32.00
15.09
544,356
—
544,356
(1) Includes 59,425, 87,000 and 123,915 shares of common stock underlying options granted in 2016, 2015 and 2014, respectively, under
our 2012 Equity Incentive Plan, which plan was approved by our stockholders on November 20, 2012 and amended on December 18,
2014 and December 21, 2016.
(2) Includes option awards issued to certain current and former directors during 2011-2012 prior to the adoption of the 2012 Equity
Incentive Plan. The options provide for annual vesting over three or four year and expire ten years from the respective issuance dates.
Purchases of Equity Securities by the Issuer and Affiliated Purchasers
None.
Recent Sales of Unregistered Securities
None.
Item 6.
Selected Financial Data.
We are a smaller reporting company and therefore, we are not required to provide information required by this Item of Form 10-K.
33
Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our results of operations and financial condition should be read in conjunction with our
financial statements and related notes appearing elsewhere in this report. This discussion and analysis contains forward-looking
statements that involve risks, uncertainties and assumptions. The actual results may differ materially from those anticipated in these
forward-looking statements as a result of certain factors, including but not limited to, those factors which are not within our control.
Amounts in this section are in thousands, unless otherwise indicated.
Overview
We were incorporated in the State of Nevada on April 11, 2007. On March 17, 2016, we merged with our wholly-owned
subsidiary and changed our name from MYOS Corporation to MYOS RENS Technology Inc. Prior to February 2011, we did not have any
operations and did not generate any revenues. In February 2011, we acquired our proprietary active ingredient called Fortetropin®, the first
clinically proven natural myostatin reducing agent. Since February 2011, our principal business activities have been focused on deepening
our scientific understanding of the activity of Fortetropin, and to leverage this knowledge to strengthen and build our intellectual property;
developing sales and marketing strategies aimed at expanding our commercial presence; evaluating the value of Fortetropin in therapeutic
markets, including the treatment of sarcopenia, cachexia, anorexia, obesity and muscular-related conditions; and, conducting research and
development focused on the discovery, development and commercialization of other products and technologies aimed at maintaining or
improving the health and performance of muscle tissue. Since our inception in April 2007, we have recognized cumulative revenues of
approximately $8.1 million.
Plan of Operation
We are focused on the discovery, development and commercialization of nutritional supplements, functional foods, therapeutic
products and other technologies aimed at maintaining or improving the health and performance of muscle tissue. Our initial core ingredient
is Fortetropin, a natural, reversible, temporary myostatin reducing agent. Our plan of action is to: (i) create a sales platform through
marketing products containing our proprietary ingredient Fortetropin in established, growing, and new markets and strategic selection of
partnerships and collaborations to maximize near-term and future revenues, (ii) deepen the scientific understanding of the activity of
Fortetropin, specifically as a natural, reversible, temporary modulator of the regulatory protein myostatin, and to leverage this knowledge to
strengthen and build our intellectual property, (iii) conduct research and development activities to evaluate myostatin modulation in a range
of both wellness and disease states, (iv) identify other products and technologies which may broaden our portfolio and define a business
development strategy to protect, enhance and accelerate the growth of our products, (v) reduce the cost of manufacturing through process
improvement, and (vi) identify contract manufacturing resources that can fully meet our future growth requirements. We believe that
myostatin regulation represent a rational entry point for our drug discovery efforts and are evaluating therapeutic targets in this area.
Our commercial focus is to leverage our clinical data to develop multiple products to target the large, but currently underserved,
markets focused on muscle health. The sales channels through which we sell our products are evolving. The first product we introduced
was MYO-T12, which was sold in the sports nutrition market. MYO T-12 is a proprietary formula containing Fortetropin and other
ingredients. The formula was sold under the brand name MYO T-12 and later as MYO-X through an exclusive distribution agreement with
Maximum Human Performance (“MHP”). While the exclusive distribution agreement with MHP terminated in March 2015, MHP
continues to distribute its remaining MYO-X inventories on popular retailer websites and in specialty retailers principally in the U.S. Sales
to MHP for the year ended December 31, 2015 were $57. There were no sales to MHP in 2016. We do not expect any orders from MHP in
2017.
In February 2014, we expanded our commercial operations into the age management market through a distribution agreement with
Cenegenics Product and Lab Services, LLC (“Cenegenics”), under which Cenegenics distributes a proprietary formulation containing
Fortetropin which it previously purchased from the Company through its age management centers and its community of physicians focused
on treating a growing population of patients focused on proactively addressing age-related health and wellness concerns. On November 28,
2014, we entered into a settlement agreement with Cenegenics wherein we agreed to accept $1,900 by April 2016, in full satisfaction of
Cenegenics’ outstanding obligations with respect to units of product produced by the Company, including units that had not yet been
shipped to Cenegenics at the time of the settlement agreement. During the second quarter of 2015, Cenegenics accepted delivery of the
remaining units that we were storing on its behalf. Given the settlement agreement’s extended payment schedule, the Company deferred the
revenue and related costs and recorded the revenue and cost of sales as the payments were received in full through April 2016. The
distribution agreement with Cenegenics expired in December 2016. We do not expect any orders from Cenegenics in 2017.
34
During the second quarter of 2015 we launched Rē Muscle HealthTM, our own direct-to-consumer portfolio of muscle health bars,
meal replacement shakes and daily supplement powders each powered by a full 6.6 gram single serving dose of Fortetropin. Our Rē Muscle
Health products are sold through our e-commerce website, remusclehealth.com, and amazon.com.
On March 1, 2017 the Company announced the launch of Qurr, its Fortetropin®-powered product line formulated to support the
vital role of muscle in overall well-being as well as in fitness. The introduction of Qurr's muscle-focused, natural, over-the-counter products
will make the Qurr line available through convenient direct online ordering without a prescription. All Qurr products are blended with
Fortetropin®, MYOS' proprietary ingredient which has been clinically demonstrated to reduce serum myostatin levels, which helps increase
muscle size and lean body mass. MYOS' earlier product formulations featuring Fortetropin® have become part of the daily routine of many
athletes and fit-conscious people.
Qurr is a line of deliciously flavored puddings, powders, and shakes all proven to be safe for daily use. While pharmaceutical
companies are working on drugs to accomplish what Fortetropin® already does, there is no pharmaceutical drug that can reduce myostatin,
safely. Fortetropin® has been shown in clinical trials to reduce serum myostatin levels and increase lean muscle mass and thickness when
taken in conjunction with resistance training.
We continue to pursue additional distribution and branded sales opportunities. There can be no assurance that we will be able to
secure distribution arrangements on terms acceptable to the Company, or that we will be able to generate significant sales of our current
and future branded products. We expect to continue developing our own core branded products in markets such as functional foods, sports
and fitness nutrition and rehab and restorative health and to pursue international sales opportunities. We expect to pursue distribution
opportunities in countries in Southeast Asia where we believe there may be significant demand for our products.
The Company currently relies on one third-party manufacturer to produce Fortetropin. This manufacturer purchases all the
necessary raw materials from suppliers and coordinates any additional production steps with third-parties. We have multiple vendors for
blending, packaging and labeling our products. The Company is pursuing other supply alternatives. See Risk Factors – “We are dependent
on third-party manufacturers, suppliers and processors” for additional information regarding our relationship with our third-party
manufacturers.
As an early-stage bionutritional and biotherapeutics company, we are dedicated to basic and clinical research that supports our
existing and future product portfolio. Our research program is actively evaluating the many active proteins, lipids and peptides in
Fortetropin, specifically as a natural, reversible, temporary modulator of the regulatory protein myostatin, and to leverage this knowledge to
strengthen and build our intellectual property. We are dedicated to protecting our innovative technology and believe that our research
programs will establish a basis for the continued submission of patent applications to help protect the Company's intellectual property. We
expect our investment in research and development to continue to grow in the future.
Strategic Investment Transaction
On December 17, 2015, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with RENS
Technology Inc. (the “Purchaser”), pursuant to which the Purchaser agreed to invest $20.25 million in the Company (the “Financing”) in
exchange for (i) an aggregate of 3,537,037 shares (the “Shares”) of the Company’s common stock, par value $0.001 per share (“Common
Stock”), and (ii) warrants to purchase an aggregate of 884,259 shares of Common Stock (the “Warrants”, and together with the Shares, the
“Securities”). The Purchaser will purchase the Securities in three tranches over twenty-four months. In the first tranche, which closed on
March 3, 2016, the Purchaser acquired 1,500,000 Shares and a warrant to purchase 375,000 shares of Common Stock (the “Initial
Warrant”) for $5.25 million.
On August 19, 2016, the Purchaser notified the Company that it did not intend to fulfill its obligation to fund the second tranche of
the Financing, notwithstanding its confirmation to the Company in June 2016 that the Purchaser would provide such funding in accordance
with the terms of the Purchase Agreement.
The Purchase Agreement provides that in the event that the Purchaser notifies the Company that it does not intend to fund the
Second Closing Subscription Amount, the Purchaser is required to take all requisite action to cause the resignation or removal of one of its
designees on the Board of Directors of the Company. Pursuant to the terms of the Purchase Agreement, effective August 23, 2016, Guiying
Zhao resigned as a director of the Company. In addition, the Purchaser’s Rights terminated, effective August 19, 2016.
35
On January 6, 2017, the Company commenced an action in the Supreme Court of New York, County of New York, against RENS
Technology, Inc., RENS Agriculture Science & Technology Co., Ltd (“RENS Agriculture”), the parent company of RENS Technology,
and Ren Ren, a principal in both entities and a director of the Company, arising from RENS Technology’s breach of a Securities Purchase
Agreement under which RENS Technology agreed to invest an aggregate of $20.25 million in the Company in exchange for an aggregate
of 3,537,037 shares of common stock of the Company and warrants to purchase an aggregate of 884,259 shares of common stock. In
addition to seeking compensatory, consequential and other damages in the action, the Company asked the Court to preliminarily restrain
RENS Technology and its agents and representatives, including, but not limited to, RENS Agriculture and Ren Ren, from selling,
transferring, conveying, assigning, hypothecating or encumbering 1,500,000 shares of common stock of the Company and a warrant
permitting the purchase of 375,000 share at a price of $7.00 per share that RENS Technology had purchased under the Securities Purchase
Agreement and, after the parties had an opportunity to submit opposition and reply papers in connection with the Company’s application, a
preliminary injunction prohibiting RENS Technology from selling, transferring, conveying, assigning, hypothecating or encumbering the
1,500,000 shares and warrant during the pendency of the action and an order attaching the stock and warrant to satisfy any judgment entered
in favor of the Company.
On January 11, 2017, the Court granted the Company the preliminary restraints that it requested, which prevents RENS
Technology, among others, from selling, transferring, conveying, assigning, hypothecating or encumbering the 1,500,000 shares of the
Company’s common stock or the aforementioned warrant. The Court scheduled a hearing on February 14, 2017, at which time the Court
heard oral argument on the application for a preliminary injunction and prejudgment attachment of the stock and warrants to satisfy any
judgment entered in favor of the Company. Since then, RENS Technology filed a motion to dismiss the complaint which the Company has
opposed. No decision has been made by the Court on these two pending applications.
Results of Operations
Year Ended December 31, 2016 Compared to Year Ended December 31, 2015
(In thousand $)
Net sales
Cost of sales
Gross profit (loss)
as a % of net revenues
Operating expenses:
Selling marketing and research
Personnel and benefit costs
Share based compensation
General and administrative
Amortization of acquired intangibles
Loss on asset impairment
Total operating expenses
as a % of net revenues
Operating loss
Other income (expense), net
Loss before income taxes
Income tax expense
Years Ended December 31,
Change
2016
2015
Dollars
%
$
$
327
319
8
2%
$
159
780
(621)
-391%
846
1,548
392
1,275
210
44
4,315
N/M
521
1,556
930
1,224
210
-
4,441
N/M
168
(461)
629
325
(8)
(538)
51
-
44
(126)
(4,307)
(5,062)
755
(34)
(14)
(20)
106%
-59%
-101%
62%
-1%
-58%
4%
0%
100%
-3%
-15%
143%
(4,341)
(5,076)
735
-9%
-
(2)
2
-100
%
Net loss
$
(4,341) $
(5,078) $
737
-14%
36
Net sales
Net sales for the year ended December 31, 2016 increased $168, or 106%, compared to net sales for the year ended December 31,
2015. The increase in net sales was primarily due to recognition of sales previously deferred of $195 to Cenegenics and Rē Muscle Health
net product sales of $136. Net sales for the year ended December 31, 2015 included Rē Muscle Health net product sales of $82, distributor
sales to MHP of $57 and other product sales of $19.
Cost of sales and gross profit
Cost of sales for the year ended December 31, 2016 decreased $461, or 59%, compared to cost of sales for the year ended
December 31, 2015. The decrease in cost of sales was primarily due to lower net sales. Cost of sales for the year ended December 31, 2016
and 2015 included slow-moving/obsolete/damaged goods inventory charges of $106 and $697, respectively.
Operating expenses
Selling, marketing and research expenses for the year ended December 31, 2016 increased $325, or 62%, compared to the year
ended December 31, 2015. The increase was primarily due to marketing and promotions costs expenses associated with the building of the
Qurr website.
General and administrative expenses for the year ended December 31, 2016 increased $51, or 4%, compared to the year ended
December 31, 2015. The increase was primarily due to a bad debt charge in 2015 of $390 offset by an adjustment for accrued rent liability
of $271,
Income tax expense
Income tax expense for the years ended December 31, 2016 and December 31, 2015 was zero and $2, which reflects minimum state
corporate taxes.
Liquidity and Capital Resources
Working capital at December 31, 2016 and December 31, 2015 is summarized as follows:
(In thousand $)
Current Assets:
Cash
Accounts receivable, net
Inventories, net
Prepaid expenses and other current assets
Total current assets
Current liabilities:
Accounts payable
Accrued expenses and other current liabilities
Convertible note
Term note
Total current liabilities
Working Capital
Current Ratio
December 31, December 31,
2016
2015
Increase
(Decrease)
$
$
1,866 $
8
1,862
85
3,821
226
417
-
-
643
3,178 $
5.94
987
(398)
395
(438)
546
(102)
(300)
(575)
(100)
(1,077)
1,623
879 $
406
1,467
523
3,275
328
717
575
100
1,720
1,555 $
1.90
Working capital increased $1,623 to $3,178 at December 31, 2016 compared to $1,555 at December 31, 2015.
Changes in working capital components were as follows:
● Cash increased $987 primarily due to $5,141 of net proceeds received from the issuance of common stock to Rens Technology Inc.
and $117 cash from the exercise of warrants, partially offset by $3,705 used in operations, $466 of capital spending, and $100
repayment of borrowing under the Term Note.
● Accounts receivable, net decreased $398 primarily due to cash collections from Cenegenics
37
● Inventories, net increased $395 primarily due to new inventory production which included $414 of Fortetropin purchases
● Prepaid expenses and other current assets decreased $438 primarily due to a $414 decrease in prepaid inventory
● Accounts payable decreased $102 primarily due to the timing of payments.
● Accrued expenses and other current liabilities decreased $300 primarily due to decrease in other accrued items of $271.
● Short-term borrowings decreased $675 resulting from the issuance of common stock to convert the promissory note previously
issued to Gan Ren, a related party of RENS, for $575 and $100 repayment under the Term Note.
At December 31, 2016, we had cash of $1,886 and total assets of $5,961 (which includes $1,907 of intangible assets).
Summarized cash flows for the years ended December 31, 2016 and 2015 are as follows:
(In thousand $)
Net cash used in operating activities
Net cash used in investing activities
Net cash provided by financing activities
Net increase (decrease) in cash
Years Ended December 31,
2016
2015
Change
$
$
(3,673) $
(381)
5,041
987 $
(2,252) $
(27)
1,591
(688) $
(1,421)
(354)
3,450
1,675
Net cash used in operating activities represents net loss adjusted for certain non-cash items and changes in operating assets and
liabilities. Net cash used in operating activities for the year ended December 31, 2016 increased $1,421 compared to the year ended
December 31, 2015 primarily due to an increase in operating expenses. For additional information about the changes in operating assets and
liabilities refer to the above discussion on working capital.
Net cash used in investing activities includes cash used to purchase capital assets. Net cash used in investing activities for the year
ended December 31, 2016 included capitalized software costs of $380.
Net cash provided by financing activities for the year ended December 31, 2016 increased by $3,450 to $5,041 and includes
proceeds of $5,250 received from the strategic investment by RENS Technology Inc. offset primarily by payment of $100 under the Term
Note and offering costs of $109.
Convertible Note
On December 17, 2015, concurrent with the execution of the Purchase Agreement with RENS Technology Inc., the Company
issued an unsecured promissory note in the principal amount of $575 (the “Note”) to Gan Ren, a related party of RENS Agriculture. The
Note accrued interest at a rate of 8% per annum and matured (the “Maturity Date”) on December 17, 2016. On the Maturity Date, the Note
and the accrued interest of $46 were automatically converted into 225,864 shares of Common Stock at $2.75 per share.
Term Note
On September 10, 2015, the Company converted its outstanding revolving note with City National Bank, which had a termination
date of August 31, 2015, into a term note (the “Term Note”). The Term Note provided that the then outstanding balance of $400 shall be
payable along with interest thereon on the last day of each month in four (4) consecutive installments of $100, with the final installment due
and payable in full on December 31, 2015. The Term Note was collateralized by all inventory, chattel paper, accounts, equipment, general
intangibles, securities and instruments and contained customary events of default, including failure to make payment and bankruptcy. As of
December 31, 2015, the interest rate on the Term Note was 4.50%. At December 31, 2015, the balance under the Term Note was $100,
which was subsequently paid in full on January 7, 2016.
Additional Financings
We may seek to raise additional capital through the issuance of debt or equity securities. Should the Company seek additional debt
and/or equity financing, it cannot assure that such financing will be available on acceptable terms, if at all.
Going Concern Uncertainty
As of the filing date of this Form 10-K, management believes that there may not be sufficient capital resources from operations and
existing financing arrangements in order to meet operating expenses and working capital requirements for the next twelve months,
primarily due to the failure of RENS Technology Inc. to fund the required amounts. These facts raise substantial doubt about the
Company's ability to continue as a going concern. Accordingly, we are evaluating various alternatives, including reducing operating
expenses, securing additional financing for future business activities and other strategic alternatives. There can be no assurance that the
Company will be able to generate the level of operating revenues in its business plan, or if additional sources of financing will be available
on acceptable terms, if at all. If no additional sources of financing are available, our future operating prospects may be adversely affected.
38
Registered Direct Offering
On February 3, 2017, the Company entered into a securities purchase agreement with an institutional investor providing for the
issuance and sale by the Company of 500,000 shares of common stock, par value in a registered direct offering at a purchase price of $4.25
per share, for gross proceeds of $2.125 million. The offering closed on February 8, 2017.
Preferred Stock Purchase Rights
Effective February 14, 2017, the Board of Directors declared a dividend of one right for each of the Company’s issued and
outstanding shares of common stock. The dividend was paid to the stockholders of record at the close of business on February 24, 2017.
Each Right entitles the registered holder, subject to the terms of the Rights Agreement to purchase from the Company one one-thousandth
of a share of the Company’s Series A Preferred Stock at a price of $7.00), subject to certain adjustments. The description and terms of the
Rights are set forth in the Rights Agreement dated as of February 14, 2017 between the Company and Island Stock Transfer, as Rights
Agent.
At-the-market Offering
On February 21, 2017, the Company entered into a sales agreement with H.C. Wainwright & Co., LLC establishing an at-the-
market equity program pursuant to which we may offer and sell up to $6.0 million of our shares of common stock from time to time through
H.C. Wainwright. As of the filing date of this Form 10-K no shares have been sold under this program.
Long-term Contractual Obligations
As of December 31, 2016, the Company’s enforceable and legally binding contractual obligations include future minimum lease
payments under a non-cancellable operating lease and purchase obligations under a long-term supply agreement.
At December 31, 2016, the future minimum lease payments under the non-cancellable operating lease in excess of one year were
as follows:
(In thousand $)
Years Ended December 31,
2017
2018
2019
Total
Amount
69
71
72
212
$
$
For additional information about the operating lease refer to PART IV, Item 15, “Notes to Consolidated Financial Statements:
Note 12 – Commitments and Contingencies – Operating Lease.”
On November 18, 2016, we entered into an Amended Supply Agreement with DIL Technologie GmbH (“DIL”). Pursuant to the
agreement (and so long as the agreement is effective), DIL will manufacture and supply the Company with Fortetropin®, the active
ingredient for its products, and the Company will purchase quantities of Fortetropin® from DIL in its discretion. DIL will manufacture the
formula exclusively for the Company in perpetuity, and may not manufacture the formula for other entities (but may manufacture it for its
own non-commercial research). The Company agreed, commencing January 2017, to pay DIL €10,000 per month for collaborative
research. The monthly payments terminate upon the earlier of: (a) the date that the Company orders additional product in accordance with
the terms of the agreement and (b) December 31, 2018, and the Company has no further financial obligations to DIL thereafter. The
Company also agreed to pay DIL €400,000 in satisfaction of all prior liabilities and obligations under its prior agreements with DIL. The
agreement expires on December 31, 2018, and the Company has the unilateral right to renew the agreement for subsequent one-year terms.
39
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our
financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital
resources.
Recent Accounting Pronouncements
In January 2017, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) No. 2017-04,
Simplifying the Test for Goodwill, which accomplishes exactly what its title indicates by eliminating the second step in the current
goodwill impairment calculation. Currently there is a two-step process for determining the amount of any goodwill impairment. In Step 1
an entity determines if the carrying value of the reporting unit (for which goodwill has been recorded) exceeds the fair value of the
reporting unit. If the calculation in Step 1 indicates that the carrying value of a reporting unit for which goodwill has been recorded exceeds
the fair value, the entity would have to determine the implied fair value of the reporting unit’s goodwill. An impairment would be recorded
to the extent that the goodwill carrying value exceeded the implied fair value of goodwill at the reporting date. The amount of any
goodwill impairment must take into consideration the effects of income taxes for any tax deductible goodwill. The effective date to adopt
the ASU is for fiscal years beginning after December 15, 2019. The ASU is to be applied prospectively. Early adoption is permitted. The
Company has evaluated the impact of the updated guidance and has determined that the adoption of ASU 2017-04 is not expected to have a
significant impact on its consolidated financial statements.
In August 2016, the FASB issued ASU 2016-15, “Classification of Certain Cash Receipts and Cash Payments (a consensus of the
Emerging Issues Task Force).” The amendments in this Update relate to eight specific types of cash receipts and cash payments which
current GAAP either is unclear or does not include specific guidance on the cash flow classification issues. The amendments in this Update
are effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years.
Early adoption is permitted, including adoption in an interim period. If an entity early adopts the amendments in an interim period, any
adjustments should be reflected as of the beginning of the fiscal year that includes that interim period. An entity that elects early adoption
must adopt all of the amendments in the same period. The Company will adopt the provisions of this ASU for its fiscal year beginning
January 1, 2017. The adoption of ASU 2016-15 is not expected to have a significant impact on its consolidated financial statements.
In May 2016, the FASB issued ASU 2016-12, “Revenue from Contracts with Customers (Topic 606), Narrow Scope
Improvements and Practical Expedients.” The amendments in ASU 2016-12 affect only the narrow aspects of Topic 606 that are outlined in
ASU 2016-12. The Company has evaluated the impact of the updated guidance and has determined that the adoption of ASU 2016-12 is
not expected to have a significant impact on its consolidated financial statements.
In April 2016, the FASB issued ASU 2016-10 “Revenue from Contracts with Customers: Identifying Performance Obligations and
Licensing.” The amendments in this Update affect entities with transactions included within the scope of Topic 606. The scope of that
Topic includes entities that enter into contracts with customers to transfer goods or services (that are an output of the entity’s ordinary
activities) in exchange for consideration. The Company has evaluated the impact of the updated guidance and has determined that the
adoption of ASU 2016-10 is not expected to have a significant impact on its consolidated financial statements.
In March 2016, the FASB issued ASU No. 2016-09, Compensation – Stock Compensation (Topic 718): Improvements to
Employee share-Based Payment Accounting (ASU 2016-09”). ASU 216-09 provides guidance designed to simplify several aspects of the
accounting for share-based payment transactions, including guidance relating to accounting for income taxes with respect to share-based
payment awards; providing generally that excess tax benefits related to share-based awards should be recorded as a reduction to income tax
expense (currently, excess tax benefits generally are recorded to additional-paid-in-capital); providing generally that excess tax benefits
related to share-based awards should be classified along with other income tax cash flows as an operating activity (currently, excess tax
benefits generally are separated from other income tax cash flows and classified as a financing activity); providing that an entity may make
an accounting policy election either to base compensation cost accruals on the number of awards expected to vest (as required by current
guidance) or to account for forfeitures when they occur; modifying the current exception to liability classification such that partial cash
settlement of an award for tax withholding purposes would not result, by itself, in liability classification of the award if the amount withheld
does not exceed the maximum statutory tax rate in the employees' applicable jurisdictions (currently, an award cannot qualify for equity
classification, rather than liability classification, if the amount withheld exceeds the minimum statutory withholding requirements); and
providing that cash paid by an employer when directly withholding shares for tax withholding purposes should be classified as a financing
activity on the statement of cash flows (currently there is no authoritative guidance addressing this classification issue). The guidance is
effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2016. Early adoption is permitted (if
early adoption occurs in an interim period, any adjustments will be reflected as of the beginning of the fiscal year that includes the interim
period). Depending on the particular issue addressed by the guidance, application of the guidance will be made prospectively,
retrospectively or subject to a retrospective transition method. We are currently evaluating the potential impact of adopting this guidance on
the Company's results of operations, cash flows and financial position.
40
In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU 2016-02”), which requires lessees to recognize
on the balance sheet the assets and liabilities for the rights and obligations created by leases with lease terms of more than 12 months. The
recognition, measurement, and presentation of expenses and cash flows arising from a lease by a lessee will continue to primarily depend
on its classification as a finance or operating lease. However, unlike current accounting principles generally accepted in the U.S. (“U.S.
GAAP”), which requires only capital leases to be recognized on the balance sheet, ASU 2016-02 will require both types of leases to be
recognized on the balance sheet. ASU 2016-02 also requires disclosures about the amount, timing, and uncertainty of cash flows arising
from leases. These disclosures include qualitative and quantitative requirements, providing additional information about the amounts
recorded in the financial statements. ASU 2016-02 is effective for us beginning January 1, 2019, with early application permitted. We are
currently evaluating the effect that the updated standard will have on our consolidated financial statements.
In November 2015, the FASB issued ASU No. 2015-17, Income Taxes (Topic 740): Balance Sheet Classification of Deferred
Taxes (“ASU 2015-17”) ASU 2015-17 requires that deferred tax assets and liabilities be classified as noncurrent in a classified statement of
financial position. The amendments in this Update may be applied either prospectively to all deferred tax liabilities and assets or
retrospectively to all periods presented and is effective for periods beginning after December 15, 2016. The Company has evaluated the
impact of the updated guidance and has determined that the adoption of ASU 2015-17 does not expect to have a significant impact on its
consolidated financial statements.
In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory (“ASU
2015-11”), which changes the measurement principle for inventory from the lower of cost or market to the lower of cost and net realizable
value. ASU 2015-11 defines net realizable value as estimated selling prices in the ordinary course of business, less reasonably predictable
costs of completion, disposal, and transportation. The new guidance must be applied on a prospective basis by us beginning January 1,
2017, with early adoption permitted. The Company has evaluated the impact of the updated guidance and has determined that the adoption
of ASU 2015-17 is not expected to have a significant impact on its consolidated financial statements.
In April 2015, the FASB issued ASU No. 2015-03, “Simplifying the Presentation of Debt Issuance Costs” (“ASU 2015-03”),
which requires all debt issuance costs be presented in the balance sheet as a direct deduction from the carrying value of the associated debt.
Prior to the issuance of this standard, debt issuance costs, which are specific incremental costs, other than those paid to the lender, that are
directly attributable to issuing a debt instrument (i.e., third party costs), were required to be presented in the balance sheet as a deferred
charge (i.e., an asset). Under ASU 2015-03, the presentation of debt issuance costs is consistent with the presentation for a debt discount,
(i.e., a direct adjustment to the carrying value of the debt). ASU 2015-03 does not affect the recognition and measurement of debt issuance
costs. Accordingly, the amortization of such costs should continue to be calculated using the interest method and be reported as interest
expense. ASU 2015-03 is effective for us beginning January 1, 2016. The Company has evaluated the impact of the updated guidance and
has determined that the adoption of ASU 2015-03 does not expect to have an impact on its consolidated financial statements.
In August 2014, the FASB issued ASU No. 2014-15, “Presentation of Financial Statements – Going Concern (Subtopic 205-40):
Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern” (“ASU 2014-15”). The amendments in this update
define management’s responsibility to evaluate whether there is substantial doubt about an organization’s ability to continue as a going
concern and provides related footnote disclosure requirements. Under U.S. GAAP, financial statements are prepared under the presumption
that the reporting organization will continue to operate as a going concern, except in limited circumstances. Financial reporting under this
presumption is commonly referred to as the going concern basis of accounting. The going concern basis of accounting establishes the
fundamental basis for measuring and classifying assets and liabilities. This update provides guidance on when there is substantial doubt
about an organization’s ability to continue as a going concern and how the underlying conditions and events should be disclosed in the
footnotes. It is intended to reduce diversity that existed in footnote disclosures because of the lack of guidance about when substantial doubt
existed. The amendments in this update are effective for us beginning January 1, 2017. Early application is permitted. The Company has
evaluated the impact of the updated guidance and has disclosed the impact in the footnotes on its consolidated financial statements.
41
In May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers” (“ASU 2014-09”). ASU 2014-09
supersedes nearly all existing revenue recognition guidance under U.S. GAAP and requires revenue to be recognized when promised goods
or services are transferred to customers in an amount that reflects the consideration that is expected to be received for those goods or
services. Additionally, qualitative and quantitative disclosures are required about customer contracts, significant judgments and changes in
judgments, and assets recognized from the costs to obtain or fulfill a contract. This accounting guidance is effective for us beginning
January 1, 2018 using one of two prescribed transition methods. We are currently evaluating the effect that the updated standard will have
on our consolidated financial statements.
Critical Accounting Policies
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities, equity and the disclosures of contingent assets and liabilities at the date of the
financial statement and the reported amounts of revenues and expenses during the reporting period. Making estimates requires management
to exercise significant judgment. It is at least reasonably possible that the estimate of the effect of a condition, situation or set of
circumstances that existed at the date of the financial statements, which management considered in formulating its estimate, could change
in the near term due to one or more future non-conforming events. Accordingly, the actual results could differ significantly from estimates.
Significant items subject to such estimates include but are not limited to the valuation of stock-based awards, measurement of allowances
for doubtful accounts and inventory reserves, the deferred tax asset valuation, the selection of asset useful lives, fair value estimations used
to test long-lived assets, including intangibles, for impairment and provisions necessary for assets and liabilities.
The Company has recorded minimal sales to its distributors during the past ten consecutive quarters, and has only recently
launched its Qurr branded products. Management’s estimates, including evaluation of impairment of long-lived assets and inventory
reserves are based in part on forecasted future results. A variety of factors could cause actual results to differ from forecasted results and
these differences could have a significant effect on asset carrying amounts.
Concentrations of Credit Risk
Management regularly reviews accounts receivables, and if necessary, establishes an allowance for doubtful accounts that reflects
management’s best estimate of amounts that may not be collectible based on historical collection experience and specific customer
information. Bad debt expense recognized as a result of an allowance for doubtful accounts is classified under selling, general and
administrative expenses in the statements of operations. If we are unable to collect our outstanding accounts receivable from our
distributors, or if our distributors are unable or unwilling to purchase our products, our operating results and financial condition will be
adversely affected.
As part of our ongoing liquidity assessments, management evaluates our cash and cash equivalents. The amount of funds held in
the bank can fluctuate due to the timing of receipts and payments in the ordinary course of business and other reasons, such as business-
development activities. As a result, the Company may have exposure to cash in excess of FDIC insured limits.
Fair Value of Long-Lived Assets
We test long-lived assets, including fixed assets and intangibles with finite lives, for recoverability when events or changes in
circumstances indicate that the net carrying amount is greater than its fair value. Assets are grouped and evaluated at the lowest level for
their identifiable cash flows that are largely independent of the cash flows of other groups of assets. We consider historical performance
and future estimated results in our evaluation of potential impairment and then compare the carrying amount of the asset to the future
estimated cash flows expected to result from the use of the asset. If the carrying amount of the asset exceeds estimated expected
undiscounted future cash flows, we measure the amount of impairment by comparing the carrying amount of the asset to its fair value. The
estimation of fair value is generally measured by discounting expected future cash flows at the rate we utilize to evaluate potential
investments. We estimate fair value based on the information available in making the necessary estimates, judgments and projections.
42
Our policy is to evaluate intangible assets subject to amortization for possible impairment whenever events or changes in
circumstances indicate that the carrying amount of such assets may not be recoverable. Impairment testing of intangible assets subject to
amortization involves comparing the carrying amount of the asset to the forecasted undiscounted future cash flows. In the event the
carrying value of the asset exceeds the undiscounted future cash flows, the carrying value is considered not recoverable and an impairment
exists. An impairment loss is measured as the excess of the asset’s carrying value over its fair value, calculated using a discounted future
cash flow method. The computed impairment loss is recognized in the period that the impairment occurs. Assets which are not impaired
may require an adjustment to the remaining useful lives for which to amortize the asset.
Stock-based Compensation
Generally, stock-based payments are measured at their estimated fair value on the date of grant. Stock-based awards to non-
employees are re-measured at fair value each financial reporting date until performance is complete. Stock-based compensation expense
recognized during a period is based on the estimated number of awards that are ultimately expected to vest. For stock options and restricted
stock that do not vest immediately but which contain only a service vesting feature, we recognize compensation cost on the unvested shares
and options on a straight-line basis over the remaining vesting period.
The Company uses the Black-Scholes option-pricing model to estimate the fair value of options and the market price of our
common stock on the date of grant for the fair value of restricted stock issued. Our determination of fair value of stock-based awards is
affected by our stock price as well as assumptions regarding a number of highly complex and subjective variables. These variables include,
but are not limited to our expected stock price volatility over the term of the awards, and certain other market variables such as the risk free
interest rate.
Income Taxes
We account for income taxes using an asset and liability approach which allows for the recognition and measurement of deferred
tax assets based upon the likelihood of realization of tax benefits in future years. Under the asset and liability approach, deferred taxes are
provided for the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting
purposes and the amounts used for income tax purposes. A valuation allowance is provided for deferred tax assets if it is more likely than
not these items will either expire before we are able to realize their benefits, or that future deductibility is uncertain.
We record a valuation allowance for deferred tax assets, if any, based on our estimates of future taxable income as well as tax
planning strategies when it is more likely than not that a portion or all of its deferred tax assets will not be realized. If we are able to utilize
more of our deferred tax assets than the net amount previously recorded when unanticipated events occur, an adjustment to deferred tax
assets would increase our net income when those events occur.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
We are a smaller reporting company, and therefore, we are not required to provide information required by this Item of Form 10-
K.
Item 8.
Financial Statements and Supplemental Data.
The Company’s financial statements for the fiscal years ended December 31, 2016, and 2015 have been examined to the extent
indicated in their reports by our independent registered accountants and have been prepared in accordance with U.S. GAAP pursuant to
regulations promulgated by the SEC. The aforementioned financial statements are included herein under Item 15.
Item 9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
On May 19, 2016, the audit committee of the board of directors dismissed EisnerAmper LLP (“EisnerAmper”), the Company's
independent registered public accounting firm, effective immediately. During the fiscal years ended December 31, 2015 and 2014,
EisnerAmper's audit reports on the Company's financial statements did not contain an adverse opinion or disclaimer of opinion, nor were
they qualified or modified as to uncertainty, audit scope or accounting principles. During the fiscal years ended December 31, 2015 and
2014 and the subsequent interim period preceding EisnerAmper's resignation, (i) there were no disagreements between the Company and
EisnerAmper on any matter of accounting principles or practices, financial statement disclosure or auditing scope or procedures, which
disagreements, if not resolved to EisnerAmper's satisfaction, would have caused EisnerAmper to make reference in connection with
EisnerAmper's opinion to the subject matter of the disagreement; and (ii) there were no "reportable events" as the term is described in Item
304(a)(1)(v) of Regulation S-K.
On May 19, 2016, the audit committee and the board of directors approved the engagement of WithumSmith+Brown, PC
(“Withum”) as the Company's new independent registered public accounting firm, effective immediately. During the fiscal years ended
December 31, 2015 and 2014 and through May 19, 2016, neither the Company nor anyone acting on its behalf consulted Withum with
respect to (ii) the application of accounting principles to a specified transaction, either completed or proposed, nor the type of audit opinion
that might be rendered on the Company's financial statements, and neither a written report was provided to the Company nor oral advice
provided that Withum concluded was an important factor considered by the Company in reaching a decision as to any accounting, auditing
or financial reporting issue; or (ii) any matter that was the subject of a disagreement or a "reportable event" as described in Items 304(a)(1)
(iv) and (v), respectively, of Regulation S-K.
43
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our management is responsible for establishing and maintaining a system of disclosure controls and procedures (as defined in
Rule 13a-15(e) under the Exchange Act) that is designed to provide reasonable assurance that information we are required to disclose in the
reports that we file or submit under the Exchange Act are recorded, processed, summarized and reported, within the time periods specified
in the Commission’s rules and forms. Disclosure controls and procedure include, without limitations, controls and procedures designed to
ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated
and communicated to the issuer’s management, including its principal executive officer or officers and principal financial officer or
officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
In accordance with Exchange Act Rules 13a-15 and 15d-15, an evaluation was completed by our Principal Executive Officer and
Principal Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the
period covered by this Annual Report. Based on that evaluation, these officers concluded that our disclosure controls and procedures were
effective.
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control
over financial reporting is defined in Rule 13a-15(f) promulgated under the Securities Exchange Act of 1934 as a process designed by, or
under the supervision of, our principal executive officer and principal financial officer and effected by our board of directors, management
and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with accounting principles generally accepted in the United States of America and includes
those policies and procedures that:
● Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our
assets;
● Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance
with accounting principles generally accepted in the United States of America and that our receipts and expenditures are being made
only in accordance with authorizations of our management and board of directors; and
● Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets
that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Internal
control over financial reporting is a process that involves human diligence and compliance and is subject to lapses in judgment and
breakdowns resulting from human failures. Internal control over financial reporting also can be circumvented by collusion or improper
management override. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. All internal
control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can
provide only reasonable assurance with respect to financial statement preparation and presentation. Because of the inherent limitations of
internal control, there is a risk that material misstatements may not be prevented or detected on a timely basis by internal control over
financial reporting. However, these inherent limitations are known features of the financial reporting process. Therefore, it is possible to
design into the process safeguards to reduce, though not eliminate, this risk.
As of December 31, 2016, management assessed the effectiveness of our internal control over financial reporting based on the
criteria for effective internal control over financial reporting established in Internal Control-Integrated Framework (2013) issued by the
Committee of Sponsoring Organizations of the Treadway Commission and SEC guidance on conducting such assessments. Based on that
evaluation, they concluded that, during the period covered by this report, such internal controls and procedures were effective.
This annual report does not include an attestation report of our registered public accounting firm regarding internal control over
financial reporting. Management’s report was not subject to attestation by our registered public accounting firm pursuant to rules of the
SEC that permit us to provide only the management’s report in this annual report.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) of
the Exchange Act) during the most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our
internal control over financial reporting.
Item 9B. Other Information.
None.
44
Item 10.
Directors and Executive Officers and Corporate Governance.
Our directors and executive officers are as follows:
PART III
Name
Dr. Robert J. Hariri
Ren Ren
Joseph Mannello
Dr. Louis J. Aronne
Christopher Pechock
Victor Mandel
John Nosta
Bin Zhou
Age
Position
Class
58
55
59
61
52
52
57
38
Chairman of the Board of Directors
Director (Global Chairman)
Interim Chief Executive Officer and Director
Director
Director
Director
Director
Director
I
I
III
II
II
III
III
I
Our Board is classified into three separate classes, as nearly equal in number as possible, with one class to be elected annually for
staggered three-year term or until their respective successors are duly elected and qualified, or until their earlier resignation, removal or
death.
The term of our current Class III directors will expire at the 2019 Annual Meeting of Stockholders, the term of our current Class II
directors will expire at the 2017 Annual Meeting of Stockholders and the term of our current Class I directors will expire at the 2018
Annual Meeting of Stockholders. Any director chosen as a result of a newly created directorship or to fill a vacancy on the Board would
hold office for a term expiring at the next Annual Meeting of Stockholders for the class identified. This does not change the present number
of directors or the Board’s authority to change that number and to fill any vacancies or newly created directorships.
The experience of each or our directors and executive officers is as follows:
Dr. Robert J. Hariri joined us as a Director in July 2011 and was elected Chairman of the Board in April 2012. Dr. Hariri has
served as the chairman and chief scientific officer of Celgene Cellular Therapeutics, a division of Celgene Corporation (NASDAQ: CELG),
since 2014. From 2002 to 2014, he served in various positions at Celgene Cellular Therapeutics, including chief executive officer and
president. Prior to joining Celgene Cellular Therapeutics, Dr. Hariri was founder, chairman and chief scientific officer at Anthrogenesis
Corporation/LIFEBANK, Inc., a privately held biomedical technology and service corporation involved in the area of human stem cell
therapeutics, which was acquired by Celgene Corporation in 2002. Dr. Hariri also serves as president of Human Longevity Cellular
Therapeutics, Inc., a privately-held genomics and cell therapy-based diagnostic and therapeutic company focused on extending the healthy,
high performance human life span, which he co-founded in 2013. He has also served as co-founder, vice chairman and chief scientific
officer of Neurodynamics, a privately held medical device and technology corporation. Dr. Hariri is an adjunct associate professor of
pathology at the Mount Sinai School of Medicine and has also held key academic positions at Weill Medical College of Cornell University
and the Cornell University Graduate School of Medical Science, including serving as the director of the Center for Trauma Research. Dr.
Hariri is also a director of Cryoport, Inc. (NASDAQ: CYRX), Bionik Laboratories Corp. (OTCQX: BNKL), Provista Diagnostics and
Rocket Racing, Inc. Dr. Hariri is a member of the scientific advisory board for the Archon X Prize for Genomics, which is awarded by the
X Prize Foundation. Dr. Hariri serves as a trustee of the J. Craig Venter Institute, a trustee of the Liberty Science Center and a
commissioner of the New Jersey Commission for Cancer Research. Dr. Hariri received the Thomas Alva Edison Award in 2007 and 2011,
The Fred J. Epstein Lifetime Achievement Award in 2012 and numerous other honors for his contributions to biomedicine and aviation. He
has served as a member of the board of visitors at Columbia University School of Engineering & Applied Sciences and the Science &
Technology Council of the College of Physicians and Surgeons. Dr. Hariri received his undergraduate training at Columbia College and
Columbia University School of Engineering and Applied Sciences and was awarded his M.D. and Ph.D. degrees from Cornell University
Medical College. Dr. Hariri received his surgical training at The New York Hospital-Cornell Medical Center and directed the Aitken
Neurosurgery Laboratory and the Center for Trauma Research. We believe Dr. Hariri’s training as a scientist, his knowledge and
experience with respect to the biomedical and pharmaceutical industries and his extensive research and experience qualifies him to serve on
our Board of Directors.
45
Ren Ren joined us as a Director (Global Chairman) in March 2016. Mr. Ren has more than 28 years of experiences in China’s
food and agricultural business. Since 2001, he formed and operated Beijing Seasons Investment Group Co, Ltd and RENS Agriculture
Science and Technology Co, Ltd. Mr. Ren is also chairman of China’s Nutrition and Health Guidance Committee, Editor in Chief of The
Capital Food Safety Weekly, chairman of Beijing Seasons Investment Group Co., Ltd, chairman of Anhui Woyang Huadu Properties Co.,
Ltd., chairman of Xingguo Hongtianxia Camellia Oil Co., Ltd, and chairman of Nanjing Xingfeng Ecological Agriculture Co., Ltd. From
1993 to 2001, he formed and operated multiple companies in Nanchang, Jiangxi Province, mainly engaged in agricultural products
operation and management. From 1987 to 1992, he was a department director at Sheyang Food Bureau, responsible for grain purchasing
and management. We believe Mr. Ren’s extensive knowledge and experience with respect to health and nutrition products and his extensive
food product industry background qualifies him to serve on our Board of Directors.
Joseph Mannello joined us as a Director in December 2015 and has served as our interim chief executive officer since September
2016. From May 2015 to September 2016, he served as a consultant. From March 2013 to May 2015, he served as the executive managing
director at Brean Capital LLC, an independent investment bank and asset management firm, where he also served as a member of the firm’s
operating committee. From March 2008 to March 2012, Mr. Mannello was the head of corporate credit for Gleacher & Company, Inc.
(OTC:GLCH), a publicly-traded investment bank. Prior to that, he was the head of the fixed income division of BNY Capital Markets, Inc.,
a subsidiary of The Bank of New York Mellon Corp. (NYSE:BK). We believe that Mr. Mannello’s extensive financial markets background
qualifies him to serve on our Board of Directors.
Dr. Louis Aronne joined us as a Director and a member of our Scientific Advisory Board in July 2011. Dr. Aronne is the Weill
Professor of Metabolic Research and Director of the Comprehensive Weight Control Center which he founded in 1986 at Weill-Cornell
Medical College. He is an Adjunct Clinical Associate Professor of Medicine at Columbia University College of Physicians and Surgeons.
Dr. Aronne is former president of the Obesity Society and a fellow of the American College of Physicians. He has been an investigator on
more than 40 trials, authored more than 60 papers and book chapters on obesity and edited the National Institutes of Health Practical Guide
to the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. Dr. Aronne has won several awards for teaching,
including the Leo M. Davidoff Society Prize from Albert Einstein College of Medicine in 1983 and Eliot Hochstein Teaching Award from
Cornell University in 1990. Dr. Aronne graduated Phi Beta Kappa from Trinity College with a BS in biochemistry and from Johns Hopkins
University School of Medicine. We believe Dr. Aronne’s skills as a physician and his knowledge and experience with respect to obesity
and related metabolic diseases qualifies him to serve on our Board of Directors.
Christopher Pechock joined us as a Director in February 2014. Mr. Pechock has been a partner at Matlin Patterson Global
Advisers, a global alternative asset manager, since its inception in July 2002. From November 1998 to July 2002, Mr. Pechock served as a
member of the Global Distressed Securities Group Credit Suisse (NYSE:CS). From January 1997 to October 1998, Mr. Pechock served as
a Portfolio Manager and Research Analyst at Turnberry Capital Management, L.P. Prior to that, Mr. Pechock served as a Portfolio
Manager at Eos Partners, L.P. (February 1996 to December 1996), a Vice President and high yield analyst at PaineWebber Inc. (May 1993
to January 1996) and an analyst in risk arbitrage at Wertheim Schroder & Co., Incorporated (August 1987 to April 1991). He serves on the
board of directors of Gleacher & Company, Inc. (NASDAQ: GLCH), and Oceanus LLC, a private ship-owning company. Mr. Pechock
received a BA in Economics from the University of Pennsylvania and an MBA from the Columbia University Graduate School of Business.
We believe Mr. Pechock’s extensive financial background qualifies him to serve on our Board of Directors.
Victor Mandel joined us as a director in August 2016 and previously served as a director of the Company from December 2015
until March 2016. He is the founding partner of Criterion Capital Management, LLC and has over twenty-five years of experience in
investments, corporate strategy and corporate governance. Mr. Mandel previously served as Co-Chairman of Ambac Financial Group, Inc.
(NASDAQ: AMBC) from May 2013 through December 2014 and as a director, chair of its Governance and Nominating Committee and
member of its Audit and Strategy and Risk Policy Committees from May 2013 until May 2016. Additionally, he has previously served as a
member of the board of directors and on the audit committees of Comsys IT Partners, Inc. (now a Manpower company), Broadpoint
Gleacher Securities Group, Inc. (now Gleacher & Co., Inc.), and XLHealth Corp. (now a United Healthcare company). He previously
served as the Chief Financial Officer of Circle.com (NASDAQ:CIRC) and served as Executive Vice President, Finance and Development
of Snyder Communications, Inc. (NYSE:SNC) from 1999 to 2000. From 1991 to 1999, Mr. Mandel served as vice president in the
Investment Research department at Goldman Sachs & Co. (NYSE:GS). Mr. Mandel holds an MBA in Finance from the Wharton School of
Business at the University of Pennsylvania, an A.B. in Computer Science from Harvard University, and is a Chartered Financial Analyst.
We believe Mr. Mandel’s extensive financial background qualifies him to serve on our Board of Directors.
46
John Nosta has served as the founder and president of NOSTALAB, a digital health think tank, since June 2013. He is generally
regarded as a leading global strategic and creative thinker in the digital health area. A leading voice in the convergence of technology and
health, Mr. Nosta helps define, dissect and deliberate global trends in digital health. He has also served as a member of the Google Health
Advisory Board since October 2014 and has penned HEALTH CRITICAL for Forbes, a top global blog on health and technology. For over
20 years, Mr. Nosta was part of the leadership of Omnicom and WPP, leading healthcare communication companies. Prior to founding
NOSTALAB, Mr. Nosta was employed by Ogilvy CommonHealth, a leading healthcare communication company, from April 2003 to June
2013, where he held a series of positions including Chief Creative Officer, Chief Strategic Officer and unit President. From 1990 to 1997,
he held various senior-level positions at LLNS, a division of Omnicom Group Inc. (NYSE:OMC), a leading healthcare communication
company. Mr. Nosta previously served as a director of the Company from December 2015 until March 2016. Mr. Nosta served as a
research associate at Harvard University Medical School from 1980 to 1981 and has co-authored several papers with global thought-leaders
in the field of cardiovascular physiology, with a focus on acute myocardial infarction, ventricular arrhythmias and sudden cardiac death. He
received a Bachelor of Arts degree from Boston University in 1981. We believe Mr. Nosta’s scientific and pharmaceuticals industry
background qualifies him to serve on our Board of Directors.
Bin Zhou joined us as a Director in March 2016. Mr. Zhou is an attorney licensed in the State of New Jersey. Since November
2007, he has been an attorney and a partner at Bernard & Yam, LLP, a New York law firm. He has advised companies on their public
listings on U.S. stock exchanges including NASDAQ, NYSE and OTC markets, as well as on their private and public offering of securities.
He received a bachelor’s degree in Economic Laws from Nanjing University, China, in 2001. He received a Master of Social Work from
University of Georgia in 2003 and a Juris Doctor’s degree from Rutgers University School of Law in 2006. We believe Mr. Zhou’s
extensive background in corporate compliance and international law qualifies him to serve on our Board of Directors.
Members of the Scientific Advisory Board
In addition to our Board of Directors, we maintain a Scientific Advisory Board, comprised of scientists and medical professionals
who advise us on science and medical health issues, medical conditions and health care trends as they relate to our current and future
products. Members of the Scientific Advisory Board provide us with advice, insights, contacts and other assistance based on their extensive
knowledge and experience. Specifically, they advise us on: (a) the use of myostatin modulators in the treatment of various disorders
including sarcopenia, obesity, muscle repair, anti-aging and longevity therapy, (b) the biological activities of our products and (c) the
development of clinical research programs relating to the biomedical activities and benefits of our products. We enter into advisory board
agreements with members of the Scientific Advisory Board pursuant to which they are entitled to receive a fixed number of shares of
common stock (which may vary as determined by the Board of Directors), which generally vest over a number of years. The Scientific
Advisory Board is currently comprised of the following members: Dr. Robert J. Hariri, Dr. Louis Aronne, Dr. Michael Donnelly, Dr.
Caroline Apovian and Dr. Neilank Jha.
The experience of each of the members of the Scientific Advisory Board (other than members who are our current directors,
whose experience is set forth above) is as follows:
Dr. Caroline Apovian joined the Scientific Advisory Board in February 2013. Since November 2010, Dr. Apovian has served as
Professor of Medicine and Pediatrics, in the Section of Endocrinology, Diabetes, and Nutrition at Boston University School of Medicine.
She has also served as Director of the Center for Nutrition and Weight Management at Boston Medical Center since January 2000. Dr.
Apovian is a nationally and internationally recognized authority on nutrition and has been in the field of obesity and nutrition since 1990.
Dr. Apovian was a recipient of the Physician Nutrition Specialist Award given by the American Society of Clinical Nutrition for her work
on developing and providing nutrition education, to medical students and physicians in training at Boston University School of Medicine.
She has published over 200 articles, chapters, and reviews on the topics of obesity, nutrition, and the relationship between adipose tissue
and risk of developing cardiovascular disease. Dr. Apovian has recently published a new book entitled The Age-Defying Diet and has also
written two popular books called The Overnight Diet and The ALLI Diet Plan. Dr. Apovian has been a member of The Obesity Society
since 1992, and has served on the Clinical Committee as well as Secretary/Treasurer and the Executive Committee from 2005 to 2008.
Additionally, she serves as Associate Editor for the Society's journal, Obesity. Dr. Apovian received her BA from Barnard College and her
MD from the University of Medicine and Dentistry of New Jersey.
Dr. Neilank Jha joined the Scientific Advisory Board in December 2011. Since July 2010, Dr. Jha has served as a Clinical Fellow
in the Spinal Program of Toronto Western Hospital. From 2004 to 2010, he was in the Neurosurgery Residency Program at McMaster
University. Dr. Jha received his BS from the University of Toronto and his Doctor of Medicine from McMaster University.
Biographical information for Dr. Robert Hariri and Dr. Louis Aronne is set forth above in “Directors and Executive Officers.”
47
Board Meetings
During the fiscal year ended December 31, 2016, the Board held eleven formal meetings and otherwise acted by unanimous
written consent. We have no written policy regarding director attendance at annual meetings of stockholders. Our last annual meeting of
stockholders was held on December 21, 2016 and seven of our directors attended such meeting.
Director Independence
The Board evaluates the independence of each nominee for election as a director in accordance with the Nasdaq listing rules (the
“Nasdaq Listing Rules”). Pursuant to these rules, a majority of our Board must be “independent directors” within the meaning of the
Nasdaq Listing Rules, and all directors who sit on our Audit Committee and Compensation Committee must also be independent directors.
The Nasdaq definition of “independence” includes a series of objective tests, such as the director or director nominee is not, and
was not during the last three years, our employee and has not received certain payments from, or engaged in various types of business
dealings with, us. In addition, as further required by the Nasdaq Listing Rules, the Board has made a subjective determination as to each
independent director that no relationships exist which, in the opinion of the Board, would interfere with such individual’s exercise of
independent judgment in carrying out his or her responsibilities as a director. In making these determinations, the Board reviewed and
discussed information provided by the directors with regard to each director’s business and personal activities as they may relate to us and
our management.
As a result, the Board has affirmatively determined that other than Mr. Ren and Mr. Mannello, none of our directors has a material
relationship with the Company. The Board has also affirmatively determined that all members of our Audit Committee and Compensation
Committee are independent directors.
Audit Committee and Audit Committee Financial Expert
In April 2014, we established a separately-designated standing Audit Committee in accordance with Section 3(a) (58) (A) of the
Exchange Act and the Nasdaq Listing Rules. The Audit Committee is comprised of Victor Mandel (chair), Chris Pechock and Bin Zhou.
Our Board has determined that Mr. Mandel qualifies as an audit committee financial expert as defined by the rules of the SEC, based on his
education, experience and background. During the fiscal year ended December 31, 2016, the Audit Committee held four formal meetings.
The Audit Committee:
● oversees the accounting and financial reporting processes of the Company and the audits of the financial statements of the
Company;
● meets at least once per fiscal year with the Company’s outside auditors with respect to matters relating to the Company’s accounting
and financial reporting processes, the audits of the Company’s financial statements, the Company’s application of accounting
principles and the Company’s internal controls, and advises the Board of Directors with respect thereto;
● is responsible for ensuring its receipt from the outside auditors of a formal written statement delineating all relationships between
the auditor and the Company, actively engaging in a dialogue with the auditor with respect to any disclosed relationships or services
that may impact the objectivity and independence of the auditor and taking, or recommending that the full Board take, appropriate
action to oversee the independence of the outside auditor;
● is directly responsible for the appointment, compensation, retention, oversight of the work and, where appropriate, replacement of
any registered public accounting firm engaged for the purpose of preparing or issuing an audit report or performing other audit,
review or attest services for the Company, and each such registered public accounting firm must report directly to the Audit
Committee; and
● oversees procedures established for (i) the receipt, retention and treatment of complaints received by the Company regarding
accounting, internal accounting controls or auditing matters; (ii) confidential, anonymous submissions by the Company’s employees
of concerns regarding questionable accounting or auditing matters and compliance with the Company’s Code of Ethics; and (iii) the
review and oversight of all related party transactions.
Compensation Committee
In April 2014, we established a separately-designated standing Compensation Committee in accordance with the Nasdaq Listing
Rules. The Compensation Committee is comprised of Christopher Pechock (chair) and Dr. Louis J. Aronne. During the fiscal year ended
December 31, 2016, the Compensation Committee held 3 formal meetings.
The Compensation Committee:
● oversees the compensation policies and their specific application to our executive officers;
● prepares an annual report on executive compensation for inclusion in the our Annual Report on Form 10-K and/or proxy statement;
● negotiates and approves the compensation of our chief executive officer and our other executive officers;
● selects a peer group of companies against which to compare our compensation of our executive officers, if it deems such
comparison necessary;
● monitors compensation trends and solicits independent advice when deemed appropriate; and
● approves, rejects or modifies incentive bonus compensation plans for our senior management, as recommended by management.
48
Director Nominations
Our Board of Directors does not maintain a separate nominating committee. Functions customarily performed by a nominating
committee are performed by the independent members of our Board. In evaluating and determining whether to nominate a candidate for a
position on the Board, the independent members of our Board utilize a variety of methods and considers criteria such as high professional
ethics and values, experience on the policy-making level in business or scientific/medical research experience relevant to our product
candidates and a commitment to enhancing stockholder value. Candidates may be brought to the attention of the independent members of
the Board by current Board members, stockholders, officers or other persons. The independent members of the Board will review all
candidates in the same manner regardless of the source of the recommendation.
We have no formal policy regarding diversity of our Board of Directors. The independent members of our Board may therefore
consider a broad range of factors relating to the qualifications and background of nominees, which may include diversity, which is not only
limited to race, gender or national origin. The priority of the independent members of our Board in selecting members of the Board of
Directors is identifying persons who will further the interests of our stockholders through his or her established record of professional
accomplishment, the ability to contribute positively to the collaborative culture among Board members and professional and personal
experiences and expertise relevant to our growth strategy.
The independent members of the Board also consider stockholder recommendations for director nominees that are properly
received in accordance with the applicable rules and regulations of the SEC. In order to validly nominate a candidate for election or
reelection as a director, stockholders must give timely notice of such nomination in writing to our Corporate Secretary and include, as to
each person whom the stockholder proposes to nominate, all information relating to such person that is required to be disclosed in
solicitations of proxies for the election of directors in an election contest, or is otherwise required, in each case pursuant to Regulation 14A
under the Exchange Act, and the rules and regulations thereunder (including such person’s written consent to being named in the proxy
statement as a nominee and to serving as a director if elected).
Board Leadership Structure
Dr. Robert J. Hariri serves as Chairman of the Board of Directors and Mr. Ren serves as our Global Chairman. Mr. Mannello
currently serves as our principal executive officer. The Board of Directors has chosen to separate the principal executive officer and
chairman positions because it believes that (i) independent oversight of management is an important component of an effective board of
directors and (ii) this structure benefits the interests of all stockholders. If the Board of Directors convenes for a special meeting, the non-
management directors will meet in executive session if circumstances warrant. Given the composition of the Board of Directors with a
strong slate of independent directors, the Board of Directors does not believe that it is necessary to formally designate a lead independent
director at this time, although it may consider appointing a lead independent director if circumstances change. We believe that the structure
described above is the best structure to lead us in the achievement of our goals and objectives and establishes an effective balance between
management leadership and appropriate oversight by independent directors.
49
Board Role in Risk Oversight
Senior management is responsible for assessing and managing our various exposures to risk on a day-to-day basis, including the
creation of appropriate risk management programs and policies. The Board is responsible for overseeing management in the execution of its
responsibilities and for assessing our approach to risk management. In addition, an overall review of risk is inherent in the Board’s
consideration of our long-term strategies and in the transactions and other matters presented to the Board, including capital expenditures,
acquisitions and divestitures, and financial matters.
Code of Ethics
We have adopted a corporate Code of Ethics. The text of our Code of Ethics, which applies to our employees, officers and
directors, is posted in the “Corporate Governance” section of our website, http://www.myosrens.com. A copy of our Code of Conduct and
Ethics is also available in print, free of charge, upon written request to 45 Horsehill Road, Suite 106, Cedar Knolls, New Jersey 07927,
Attention: Joseph Mannello.
Compliance with Section 16(a) of the Exchange Act
Section 16(a) of the Securities Exchange Act of 1934, as amended requires our directors and executive officers, and persons who
beneficially own more than 10% of a registered class of our equity securities, to report their initial beneficial ownership and any subsequent
changes in that beneficial ownership of our securities to the SEC. Based solely on a review of the copies of the reports furnished to us, we
believe that all such reports for the year ended December 31, 2016 were filed on a timely basis with the exceptions of two late Form 4
filings for Mr. Lyu and one late Form 4 filing for each of Messrs Ren, Zhou and Aronne.
Item 11.
Executive Compensation.
Summary Compensation Table
The table below sets forth the compensation earned for services rendered to us, for fiscal years indicated, by our executive
officers.
Name and Position
Fiscal
Year
Salary
($)
Bonus
($)
Stock
Awards
($)
Option
Awards
($) (6)
All Other
Compensation
($) (7)
Total
($)
Joseph Mannello (5)
(Interim Chief Executive Officer)
2016
2015
K. Bryce Toussaint (1)
(Former Chief Executive Officer)
2016
2015
82,600
-
173,569
9,230
-
-
-
-
12,631
-
1,755
22,700
-
-
-
-
16,081
-
111,312
-
4,123
20,000
179,447
51,930
Joseph C. DosSantos (2)
(Former Chief Financial Officer)
2016
2015
122,437
200,000
50,000
50,000
-
9,350
-
52,700
-
37,660
172,437
349,710
Dr. Robert C. Ashton, Jr. (3)
(Former Chief Medical Officer)
Peter Levy (4)
(Former President) (4)
2016
2015
2016
2015
55,687
237,167
50,000
50,000
-
171,475
-
-
-
-
-
-
-
52,700
-
52,700
-
39,781
105,687
379,648
-
21,165
-
245,340
(1) K.Bryce Toussaint was hired as Chief Executive Officer on December 17, 2015 and resigned on August 31, 2016.
(2) On June 30, 2016, Joseph C. DosSantos resigned as the Chief Financial Officer.
(3) Dr. Ashton resigned as Chief Medical Officer on January 31, 2016.
50
(4) Mr. Levy resigned as President, Chief Operating Officer on September 7, 2015.
(5) On August 26, 2016, the board of directors appointed Joseph Mannello as the Company’s interim Chief Executive Officer, effective as
of September 1, 2016.
(6) Amounts reflect the aggregate grant date fair value of stock option awards computed in accordance with Accounting Standards
Codification (“ASC”) 718, “Compensation – Stock Compensation.” The assumptions used in determining the grant date fair value of
these awards for their respective years are set forth in Part IV, Item 15, “Notes to Consolidated Financial Statements: Note 10 – Stock
Compensation.”
(7) The amounts in All Other Compensation column of the Summary Compensation Table reflect the following:
Fiscal Year
2016
2015
$
$
Consulting
Agreements
-
-
Health
Insurance
Expenses
401(k)
Matching
Contribution
-
-
5,170
-
Other
Perquisites
Total Other
Compensation
5,170
-
- $
- $
2016
2015
2016
2015
2016
2015
2016
2015
$
$
$
$
$
$
$
$
-
20,000
-
-
-
-
-
-
14,590
-
14,590
29,180
-
29,180
-
14,421
-
-
4,183
8,366
-
10,487
-
6,667
- $
- $
57 $
114 $
- $
114 $
- $
77 $
14,590
20,000
18,830
37,660
-
39,781
-
21,165
Name
Joseph Mannello
K. Bryce Toussaint
Joseph C. DosSantos
Dr. Robert C. Ashton, Jr.
Peter Levy
Employment Agreements
Joseph Mannello
On August 30, 2016, we entered into an offer letter with Joseph Mannello, pursuant to which Mr. Mannello agreed to serve as our
interim Chief Executive Officer commencing September 1, 2016. Pursuant to the terms of the Offer Letter, Mr. Mannello will work a full-
time basis as an at-will employee for an annual base salary of $240,000. Mr. Mannello will be entitled to an annual bonus of up to 100% of
his annual base salary, as determined by the Board (or its compensation committee) in its sole discretion. Mr. Mannello also received a
grant of 10,000 shares of common stock which vested upon the six-month anniversary of his start date.
K. Bryce Toussaint
On December 17, 2015, we entered into an employment agreement with K. Bryce Toussaint pursuant to which Mr. Toussaint
agreed to serve as our Chief Executive Officer. Pursuant to the terms of the employment agreement, Mr. Toussaint agreed to work for us
on a full-time basis for an annual base salary of $240,000. Mr. Toussaint was to receive an annual cash bonus in an amount up to 100% of
his base salary, as may be determined by the Board in its sole discretion. Mr. Toussaint resigned as Chief Executive Officer as of August
31, 2016 and contined to serve as a member of the Company’s board of directors until December 21, 2016.
Joseph C. DosSantos
On May 19, 2014, we entered into an employment agreement with Joseph C. DosSantos pursuant to which Mr. DosSantos agreed
to serve as our Chief Financial Officer. Pursuant to the terms of the employment agreement, Mr. DosSantos worked for us on a full-time
basis for an annual base salary of $200,000. Mr. DosSantos may receive an annual cash bonus in an amount up to 50% of his base salary, as
may be determined by the Board in its sole discretion. Mr. DosSantos also received a signing bonus of $15,000. In addition, Mr. DosSantos
was granted a stock option to purchase 20,000 shares of the Company’s common stock at $12.55, which shares will vest in four equal
annual installments commencing on May 19, 2015. Mr. DosSantos resigned as Chief Financial Officer effective as of June 30, 2016.
Dr. Robert C. Ashton, Jr.
On February 12, 2014, we entered into an offer letter with Dr. Robert C. Ashton, Jr. to serve as our Chief Medical Officer.
Pursuant to the terms of the offer letter, Dr. Ashton agreed to work for us on a full-time basis as an at-will employee and receive an annual
base salary of $250,000. Dr. Ashton’s targeted annual bonus was 50% of his annual base salary, of which $50,000 was guaranteed and the
remainder was to be based on his and the Company’s performance, as determined by our board of directors in its sole discretion. Dr. Ashton
also received a stock option to purchase 20,000 shares of the Company’s common stock at $12.50 per share which was to vest in four equal
semi-annual installments commencing upon the six-month anniversary of his start date. Effective January 1, 2016, Dr. Ashton became a
part-time consultant and received a monthly retainer of $5,000 for his services. Dr. Ashton subsequently resigned as Chief Medical Officer
on January 31, 2016.
51
Peter Levy
On February 8, 2013, we entered into an amended and restated employment agreement with Peter Levy to continue to serve as our
Chief Operating Officer and Executive Vice President. The agreement replaced Mr. Levy’s existing employment agreement dated February
10, 2012. Pursuant to the terms of the agreement, Mr. Levy agreed to continue to work as Chief Operating Officer and Executive Vice
President on a full-time basis and receive an annual base salary of $200,000. Mr. Levy was to receive an annual cash bonus in an amount
up to 100% of his base salary, as may be determined by the Board in its sole discretion. The 10,000 shares of common stock previously
granted to Mr. Levy vested in four equal semi-annual installments commencing on August 10, 2012. On September 7, 2015, Mr. Levy
resigned from his positions.
Outstanding Equity Awards at 2016 Fiscal Year End
The following table presents, for each of the named executive officers, information regarding outstanding equity awards as of
December 31, 2016.
Outstanding Equity Awards
Option Awards
Number of
Securities
Underlying
Unexercised
Options
Exercisable
-
Number of
Securities
Underlying
Unexercised
Options
Unexercisable
-
Option
Exercise
Price ($)
Option
Expiration
Date
-
-
Stock Awards
Number of
Shares or
Units of
Stock That
Have Not
Vested (#)
10,000
Market
Value of
Shares or
Units That
Have Not
Vested ($)
18,600
Name
Joseph Mannello (1)
Grant Date
8/31/2016
(1) Mr. Mannello was hired as Chief Executive Officer effective September 1, 2016
52
Stock Vested at 2016 Fiscal Year End
The following table sets forth for each of the named executive officers the restricted stock that vested during 2016. No options
were exercised by the named executive officers during 2016.
Name (a)
K. Bryce Toussaint (1)(3)
Joseph DosSantos (1)(5)
Dr. Robert C. Ashton, Jr. (4)
Peter Levy (2)
Joseph Mannello
Stock Awards
Number of
Shares
Acquired on
Vesting
(b)
Value
Realized on
Vesting
($)(c)
5,000 $
5,000 $
- $
- $
- $
5,675
9,350
-
-
-
(1) The dollar amount shown in column (c) above for each of the named executive officers was determined by multiplying the number of
shares shown in column (b) by the fair value of the shares on the vesting date.
(2) Mr. Levy resigned as President on September 7, 2015.
(3) Mr. Toussaint resigned as Chief Executive Officer on August 31, 2016.
(4) Mr. Ashton resigned as Chief Medical Officer on January 31, 2016.
(5) Mr. DosSantos resigned as Chief Financial Officer on June 30, 2016.
Director Compensation
The following table summarizes the compensation for our non-employee board of directors for the fiscal year ended December 31,
2016. All compensation paid to our employee directors is included under the summary compensation table above.
Name
Dr. Robert J. Hariri
Ren Ren
Dr. Louis J. Aronne
Christopher Pechock
Victor Mandel
Bin Zhou
Stock
Awards(1)
Cash
Paid ($)
4,386 $
4,386
4,386
4,386
1,755
4,386
10,308
10,308
18,554
30,923
10,719
18,554
(1) The value of awards and stock options equals the aggregate grant date fair value of awards computed in accordance with ASC 718. The
assumptions used in determining the grant date fair value of these awards for their respective years are set forth in Part IV, Item 15,
“Notes to Consolidated Financial Statements: Note 10 - Stock Compensation.”
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
Under Rule 13d-3, a beneficial owner of a security includes any person who, directly or indirectly, through any contract,
arrangement, understanding, relationship, or otherwise has or shares: (i) voting power, which includes the power to vote, or to direct the
voting of shares; and (ii) investment power, which includes the power to dispose or direct the disposition of shares. Certain shares may be
deemed to be beneficially owned by more than one person (if, for example, persons share the power to vote or the power to dispose of the
shares). In addition, shares are deemed to be beneficially owned by a person if the person has the right to acquire the shares (for example,
upon exercise of an option) within 60 days of the date as of which the information is provided. In computing the percentage ownership of
any person, the amount of shares outstanding is deemed to include the amount of shares beneficially owned by such person (and only such
person) by reason of these acquisition rights.
The following table sets forth information known to us regarding the beneficial ownership of our common stock as of March 30,
2017 by:
● each person known by us at that date to be the beneficial owner of more than 5% of the outstanding shares of our based solely on
Schedule 13D/13G filings with the SEC;
● each of our executive officers and directors at such date; and
● all of our executive officers and directors at such date, as a group.
53
Unless otherwise indicated, we believe that all persons named in the table below have sole voting and investment power with
respect to all shares of common stock beneficially owned by them. As of March 30, 2017, there were 5,844,372 shares of our common
stock outstanding.
Name of Beneficial Owner (1)
Ren Ren (2) (7)
RENS Technology Inc. (2)
Joseph Mannello (6)
Dr. Robert J. Hariri (3)
Christopher Pechock (5)
Victor Mandel
Dr. Louis J. Aronne (4)
Bin Zhou
John Nosta
Directors and officers as a group (8 persons)
Number of
Shares
Beneficially
Owned
1,893,182
1,875,000
291,811
421,000
183,886
62,021
26,586
4,386
-
2,882,972
Percentage
of Class
32.4%
32.1%
5.2%
7.2%
3.1%
1.1%
0.5%
0.1%
-
49.6%
(1) Unless otherwise indicated, the business address of each of the individuals is c/o MYOS RENS Technology Inc., 45 Horsehill Road,
Suite 106, Cedar Knolls, New Jersey 07927.
(2) Includes 375,000 shares issuable upon a warrant. Mr. Ren has sole voting and investment control over the securities held by RENS
Technology Inc.
(3) Includes 166,000 shares held by Hariri Family Ltd. Partnership and 150,250 shares issuable upon exercise of vested stock options.
(4) Includes 30,500 shares issuable upon exercise of vested stock options.
(5) Includes 75,000 shares issuable upon exercise of warrants and 3,000 shares issuable upon exercise of vested stock options.
(6) Includes 100,001 shares issuable upon exercise of warrants.
(7) Includes 18,182 shares of common stock previously issued to Mr. Ren following the closing of the first tranche of the Financing for his
services to the Company as a member of the Board.
Item 13.
Certain Relationships and Related Transactions and Director Independence.
The following is a description of the transactions we have engaged in during the year ended December 31, 2016 and through the
date of this Report, with our directors and officers and beneficial owners of more than five percent of our voting securities and their
affiliates.
On August 1, 2015, we entered into a consulting agreement with Muscle Longevity LLC, a company that has the same owner as
Ultra Pro Sports, LLC, which was previously a greater than 5% beneficial owner of our common stock. Under the terms of the agreement,
Muscle Longevity LLC will provide introductions and referrals to new distribution channels for our products including, but not limited to,
health and wellness centers and sports nutrition companies and to conduct industry research and advise us regarding distributors, markets,
and sales opportunities for the Company’s products. As compensation for the services, Muscle Longevity LLC was paid a consulting fee of
$16,000 per month until the agreement ended on October 1, 2016.
54
On December 17, 2015, we issued an unsecured promissory note in the principal amount of $575,000 to Gan Ren, the son of Ren
Ren, a current director and our largest stockholder. The note bears interest at a rate of 8% per annum and matures one year from the date of
issuance. On December 17, 2016 the note and accrued interest of $46,000 was automatically converted into 225,864 shares of common
stock at $2.75 per share.
On December 17, 2015, we entered into the Purchase Agreement with the Purchaser, an entity which is controlled by Ren Ren, a
current director and our largest stockholder. Pursuant to terms of the Purchase Agreement, the Purchaser agreed to invest $20.25 million in
the Company in exchange for (i) an aggregate of 3,537,037 shares of common stock and (ii) warrants to purchase an aggregate of 884,259
shares of common stock. In connection with the Financing, the Board agreed to issue Mr. Ren 18,182 shares of common stock following
the closing of the Financing for his services to the Company as a member of the Board. On March 3, 2016, we completed the first tranche
of the Financing pursuant to which the Purchaser acquired 1,500,000 shares of common stock and a warrant to purchase 375,000 shares of
the Company’s common stock for $5.25 million.
On August 19, 2016, the Purchaser notified the Company that it did not intend to fulfill its obligation to fund the second tranche of
the Financing, notwithstanding its confirmation to the Company in June 2016 that the Purchaser would provide such funding in accordance
with the terms of the Purchase Agreement.
On January 6, 2017, the Company commenced an action in the Supreme Court of New York, County of New York, against the
Purchaser, the parent company of the Purchaser, and Ren Ren, a principal in both entities and a director of the Company, arising from the
Purchaser’s breach of the Purchase Agreement under which the Purchaser agreed to invest an aggregate of $20.25 million in the Company
in exchange for an aggregate of 3,537,037 shares of common stock of the Company and warrants to purchase an aggregate of 884,259
shares of common stock. In addition to seeking compensatory, consequential and other damages in the action, the Company asked the Court
to preliminarily restrain the Purchaser and its agents and representatives, including, but not limited to, RENS Agriculture and Ren Ren, from
selling, transferring, conveying, assigning, hypothecating or encumbering 1,500,000 shares of common stock of the Company and a
warrant permitting the purchase of 375,000 share at a price of $7.00 per share that the Purchaser had purchased under the Purchase
Agreement and, after the parties had an opportunity to submit opposition and reply papers in connection with the Company’s application, a
preliminary injunction prohibiting RENS Technology from selling, transferring, conveying, assigning, hypothecating or encumbering the
1,500,000 shares and warrant during the pendency of the action and an order attaching the stock and warrant to satisfy any judgment entered
in favor of the Company.
On January 11, 2017, the Court granted the Company the preliminary restraints that it requested, which prevents RENS
Technology, among others, from selling, transferring, conveying, assigning, hypothecating or encumbering the 1,500,000 shares of the
Company’s common stock or the aforementioned warrant. The Court scheduled a hearing on February 14, 2017, at which time the Court
heard oral argument on the application for a preliminary injunction and prejudgment attachment of the stock and warrants to satisfy any
judgment entered in favor of the Company. Since then, RENS Technology filed a motion to dismiss the complaint which the Company has
opposed. No decision has been made by the Court on these two pending applications.
Review, Approval or Ratification of Transactions with Related Persons.
Our Board of Directors has established an audit committee consisting of independent directors. This committee, among other
duties, is charged to review, and if appropriate, ratify all agreements and transactions which had been entered into with related parties, as
well as review and ratify all future related party transactions.
Item 14.
Principal Account Fees and Services.
From May 17, 2016 to December 31, 2016 and for fiscal year ended December 31, 2016 WithumSmith+Brown, PC, served as our
principal accountant. From January 1, 2015 to June 1, 2016 and for the fiscal year ended December 31, 2015, EisnerAmper, LLP, or
EisnerAmper, served as our principal accountant.
Audit Fees. Audit fees consist of fees for professional services rendered for the annual audits of our financial statements, quarterly
reviews of financial statements and services that are normally provided in connection with statutory and regulatory filings or engagements.
Audit fees billed by WithumSmith+Brown, PC for the fiscal year ended December 31, 2016 were approximately $84,000. Audit fees billed
by EisnerAmper for the fiscal year ended December 31, 2015 were approximately $104,000.
Audit-Related Fees. Audit-related services consist of fees for assurance and related services that are reasonably related to
performance of the audit or review of our financial statements and are not reported under “Audit Fees.” These services include attest
services that are not required by statute or regulation and consultations concerning financial accounting and reporting standards. There were
no fees billed for audit-related services rendered during the last two fiscal years.
Tax Fees . Tax services consist of fees for the preparation of federal and state tax returns. Tax fees estimated to be billed by
WithumSmith+Brown, PC for the fiscal year ended December 31, 2016 were $7,500. Tax fees paid to EisnerAmper in 2016 for the tax
return related to the fiscal year ended December 31, 2015 were $9,500.
55
PART IV
Item 15.
Exhibits and Financial Statement Schedules.
Financial Statements and Schedules
Reports of Independent Registered Public Accounting Firms
Consolidated Balance Sheets
Consolidated Statements of Operations
Consolidated Statement of Changes in Stockholders’ Equity
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
Exhibits
F-2
F-4
F-5
F-6
F-7
F-8
The following exhibits are filed herewith or are incorporated by reference to exhibits previously filed with the Securities and
Exchange Commission.
Exhibit
Number Exhibit Description
Incorporated by
Reference
Form Exhibit
Filing
Date
3.1
3.2
3.3
3.4
3.5
3.6
3.7
3.8
3.9
4.1
4.2
4.3
4.4
4.5
4.6
4.7
10.1
10.2
10.3^*
10.4
10.5
Articles of Incorporation
Amended and Restated Bylaws
Certificate of Amendment to Articles of Incorporation, dated June 8, 2010
Articles of Merger, dated May 15, 2012
Certificate of Change Pursuant to Nevada Revised Statutes 78.209, dated February
4, 2014
Certificate of Amendment to Articles of Incorporation, dated December 22, 2014
Certificate of Amendment to the Articles of Incorporation, dated March 8, 2016
Articles of Merger, dated March 17, 2016
Certificate of Designation of Series A Preferred Stock
Form of Series A Warrant
Form of Series B Warrant
Form of Series C Warrant
Form of Series E Warrant
Form of Warrant Exercise Agreement, dated May 18, 2015
Form of RENS Warrant
Rights Agreement dated as of February 14, 2017 between MYOS RENS Technology
Inc,. as the Company and Island Stock Transfer, as Rights Agents
Intellectual Property Purchase Agreement, dated February 25, 2011, by and among
the Registrant, Atlas Acquisition Corp. and Peak Wellness, Inc.
Intellectual Property Assignment Agreement, dated February 25, 2011, by and
among Atlas Acquisition Corp. and Peak Wellness, Inc.
Amended Supply Agreement by and between the Company and Deutsches Institut
fur Lebensmitteltechnik e.V. - the German Institute for Food Technologies, dated
July 18, 2014
Employment Agreement, dated December 17, 2015, by and between the Company
and K. Bryce Toussaint
Employment Agreement, dated as of May 19, 2014, by and between Joseph C.
DosSantos and the Company
SB-2
8-K
14C
8-K
8-K
8-K
8-K
8-K
8-K
8-K
8-K
10-K
10-K
8-K
8-K
8-K
8-K
8-K
8-K
8-K
3(a)
3.1
A
3.1
3.1
3.1
3.1
3.1
3.1
4.1
4.1
4.3
4.5
4.1
4.1
4.1
10.1
10.6
6/27/2007
1/11/2017
6/09/2010
5/21/2012
2/10/2014
12/23/2014
3/8/2016
3/22/2016
2/14/2017
1/28/2014
1/28/2014
3/27/2015
3/27/2015
5/19/2015
12/22/2015
2/14/2017
3/3/2011
3/3/2011
10.4
10.1
12/22/2015
5/19/2014
56
10.6*
10.7
10.8
10.9
10.10
10.11
10.13
10.14*
10.15
10.16
16.1
21.1
23.1*
23.2*
31.1**
32.1**
Employment Offer Letter, dated as of August 30, 2016, by and between Joseph
Mannello and the Company
Form of Advisory Board Agreement
Commercial Lease, dated August 1, 2012
First Amendment to Commercial Lease, dated June 6, 2014
Form of Securities Purchase Agreement, dated January 27, 2014
Form of Securities Purchase Agreement, dated November 17, 2014
2012 Equity Incentive Plan, as amended
Amendment No. 3 to 2012 Equity Incentive Plan
S-1
S-1
8-K
8-K
8-K
DEF 14A
Securities Purchase Agreement, dated December 17, 2015, by and between the
Company and RENS Technology Inc.
Exclusive Distribution Agreement, dated December 17, 2015, by and between the
Company and RENS Agriculture Science & Technology Co. Ltd.
Letter from EisnerAmper LLP, dated May 20, 2016
Subsidiaries of the Registrant
Consent of EisnerAmper LLP, Independent Registered Public Accounting Firm
Consent of WithumSmith+Brown, PC, Independent Registered Public Accounting
Firm
Certification of Principal Executive Officer and Principal Financial Officer pursuant
to Rule 13a-14(a) of the Securities Exchange Act of 1934, as amended, as adopted
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
Certification of Principal Executive Officer and Principal Financial Officer pursuant
to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002
8-K
8-K
8-K
10-K
101.INS* XBRL Instance Document.
101.SCH* XBRL Taxonomy Extension Schema Document.
101.CAL* XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF* XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB* XBRL Taxonomy Extension Label Linkbase Document.
101.PRE* XBRL Taxonomy Extension Presentation Linkbase Document.
10.6
10.1
10.1
4.1
10.1
4.5
10.1
10.2
16.1
21.1
8/6/2012
8/6/2012
6/6/2014
1/28/2014
11/19/2014
11/16/2011
12/22/2015
12/22/2015
5/20/2016
3/30/2016
*
Filed herewith
** Furnished herewith
^ Certain portions have been omitted pursuant to a confidential treatment request. Omitted information has been filed separately with the
SEC.
Item 16. Form 10-K Summary
Not applicable.
57
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its
behalf by the undersigned hereunto duly authorized.
SIGNATURES
Date: March 30, 2017
MYOS RENS Technology Inc.
/s/ Joseph Mannello
By:
Name: Joseph Mannello
Title: Chief Executive Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons
on behalf of the Registrant and in the capacities and on the dates indicated.
Name
/s/ Dr. Robert J. Hariri
Dr. Robert J. Hariri
/s/ Ren Ren
Ren Ren
/s/ Joseph Mannello
Joseph Mannello
/s/ Dr. Louis Aronne
Dr. Louis Aronne
/s/ Christopher Pechock
Christopher Pechock
/s/ Victor Mandel
Victor Mandel
/s/ Bin Zhou
Bin Zhou
/s/ John Nosta
John Nosta
Title(s)
Chairman of the Board
Global Chairman
Date
March 30, 2017
March 30, 2017
Chief Executive Officer and Director (Principal
March 30, 2017
Executive
Officer, Principal Financial Officer and Principal
Accounting Officer)
Director
Director
Director
Director
Director
58
March 30, 2017
March 30, 2017
March 30, 2017
March 30, 2017
March 30, 2017
Reports of Independent Registered Public Accounting Firms
Consolidated Balance Sheets
Consolidated Statements of Operations
Consolidated Statement of Changes in Stockholders’ Equity
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
CONTENTS
F-1
F-2
F-4
F-5
F-6
F-7
F-8
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To The Board of Directors and Stockholders of
MYOS RENS Technology Inc:
We have audited the accompanying consolidated balance sheet of MYOS RENS Technology Inc. as of December 31, 2016, and the related
consolidated statements of operations, stockholders’ equity, and cash flows for the year then ended. These financial statements are the
responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of
material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial
reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are
appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control
over financial reporting. Accordingly, we express no such opinion. An audit includes examining, on a test basis, evidence supporting the
amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant
estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audit provides a
reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of
MYOS RENS Technology Inc. as of December 31, 2016, and the consolidated results of its operations and its cash flows for the year then
ended, in conformity with accounting principles generally accepted in the United States of America.
The accompanying consolidated financial statements have been prepared assuming that the entity will continue as a going concern. As
discussed in Note 1 to the consolidated financial statements, the entity has suffered recurring losses from operations, and has an
accumulated deficit, that raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these
matters are also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the
outcome of this uncertainty. Our opinion is not modified with respect to this matter.
/s/ WithumSmith+Brown, PC
New Brunswick, New Jersey
March 30, 2017
F-2
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To The Board of Directors and Stockholders of
MYOS RENS Technology Inc. (Formerly known as MYOS Corporation):
We have audited the accompanying consolidated balance sheet of MYOS RENS Technology Inc. (formerly known as MYOS Corporation)
and Subsidiary (the “Company”) as of December 31, 2015, and the related consolidated statements of operations, stockholders’ equity, and
cash flows for the year then ended. The financial statements are the responsibility of the Company’s management. Our responsibility is to
express an opinion on these financial statements based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of
material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial
reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are
appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control
over financial reporting. Accordingly, we express no such opinion. An audit includes examining, on a test basis, evidence supporting the
amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant
estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audit provides a
reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of
MYOS RENS Technology Inc. and Subsidiary as of December 31, 2015, and the consolidated results of their operations and their cash
flows for the year then ended, in conformity with accounting principles generally accepted in the United States of America.
/s/ EisnerAmper, LLP
Iselin, New Jersey
March 30, 2016
F-3
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
(in thousands, except share amounts)
ASSETS
Current assets:
Cash
Accounts receivable, net
Inventories, net
Prepaid expenses and other current assets
Total current assets
Fixed assets, net
Intangible assets, net
Total assets
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable
Accrued expenses and other current liabilities
Convertible note
Term note
Total current liabilities
Contract liability
Total liabilities
Commitments and contingencies
December 31, December 31,
2016
2015
$
$
$
1,866 $
8
1,862
85
3,821
233
1,907
5,961 $
226 $
417
-
-
643
-
643
879
406
1,467
523
3,275
287
1,780
5,342
328
717
575
100
1,720
117
1,837
Stockholders' equity:
Preferred stock, $.001 par value; 500,000 shares authorized; no shares issued and outstanding
Common stock, $.001 par value; 12,000,000 shares authorized at December 31, 2016 and 8,000,000 at
December 31, 2015; 5,344,372 and 3,552,873 shares issued and outstanding at December 31, 2016 and
2015, respectively
Additional paid-in capital
Accumulated deficit
Total stockholders' equity
Total liabilities and stockholders' equity
-
-
5
33,099
(27,786)
5,318
5,961 $
4
26,946
(23,445)
3,505
5,342
$
See accompanying Notes to Consolidated Financial Statements
F-4
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Net revenues
Cost of sales (excludes amortization of acquired intangibles)
Gross profit (loss)
Operating expenses
Selling, marketing and research
Personnel and benefits
Share-based compensation
General and administrative
Amortization of acquired intangibles
Loss on asset impairment
Total operating expenses
Operating loss
Other income (expense):
Interest income
Interest expense
Total other expense
Loss before income taxes
Income tax provision
Net loss
Deemed dividend resulting from warrant modification
Net loss per share attributable to common shareholders:
Net loss per share attributable to common shareholders:
Basic and diluted
Weighted average number of common shares outstanding:
Basic and diluted
See accompanying Notes to Consolidated Financial Statements
F-5
$
$
$
Years Ended
December 31,
2016
2015
327 $
319
8
846
1,548
392
1,275
210
44
4,315
(4,307)
1
(35)
(34)
(4,341)
-
(4,341)
-
(4,341) $
159
780
(621)
521
1,556
930
1,224
210
-
4,441
(5,062)
1
(15)
(14)
(5,076)
(2)
(5,078)
(225)
(5,303)
(0.90) $
(1.64)
4,806
3,240
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY
(in thousands, except share amounts)
Common Stock
Additional
Amount
$.001 par
paid-in
capital
Accumulated
deficit
Total
stockholders'
equity
Balance at January 1, 2015
Issuance of common stock under Make-
Whole Provisions
Exercise of Series D Warrants, net of issuance costs
of $85
Shares issued to officers
Shares issued for services
Forfeiture of shares issued for services
Stock-based compensation expense
Net loss
Balance at December 31, 2015
Proceeds from issuance of common stock, net
Shares issued to Board of Directors for services
Vesting of options
Shares issued upon conversion of convertible note
Net loss
Balance at December 31, 2016
Shares
3,103,300 $
193,865
190,609
15,000
51,099
(1,000)
3,552,873
1,500,000
65,639
-
225,860
5,344,372
3 $
25,100 $
(18,367) $
6,736
1
-
-
-
-
-
4
1
0
-
0
5
(1)
916
9
148
-
774
26,946
5,140
117
275
621
33,099
(5,078)
(23,445)
(4,341)
(27,786)
-
916
9
148
-
774
(5,078)
3,505
5,141
117
275
621
(4,341)
5,318
See accompanying Notes to Consolidated Financial Statements
F-6
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
Cash Flows From Operating Activities:
Net loss
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation
Amortization
Change in contract liability
Provision for inventory reserve
Bad debt expense / (reversal of allowance)
Stock-based compensation
Impairment charge
Changes in operating assets and liabilities:
Decrease in accounts receivable
Increase in inventories
Decrease in prepaid expenses and other current assets
(Increase) decrease in accounts payable and accrued expenses
Net cash used in operating activities
Cash Flows From Investing Activities:
Purchase of capitalized software
Purchases of fixed assets
Net cash used in investing activities
Cash Flows From Financing Activities:
Proceeds from issuance of common stock, net
Note borrowings
Proceeds from exercise of warrants, net
Borrowings under revolving note
Repayments of term note
Net cash provided by financing activities
Net increase (decrease) in cash
Cash at beginning of year
Cash at end of year
Supplemental disclosure of cash flow information:
Cash paid during the year for:
Interest
Income taxes, net of refunds
Supplemental schedule of non-cash investing and financing activities:
Incremental fair value resulting from warrant modification
Conversion of revolving note to term note
Shares issued under Make-Whole Share provision
Issuance of common stock upon conversion of convertible note
See accompanying Notes to Consolidated Financial Statements
F-7
Years Ended
December 31,
2016
2015
$
(4,341) $
(5,078)
54
210
(117)
107
-
392
44
398
(501)
437
(356)
(3,673)
(380)
(1)
(381)
5,141
-
-
-
(100)
5,041
987
879
1,866 $
- $
- $
- $
- $
- $
621 $
53
210
16
697
(390)
931
-
966
(350)
222
471
(2,252)
-
(27)
(27)
-
575
916
400
(300)
1,591
(688)
1,567
879
13
4
225
400
430
-
$
$
$
$
$
$
$
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2016
(amounts in thousands, except share and per share amounts, unless otherwise indicated)
NOTE 1 – NATURE OF OPERATIONS, BASIS OF PRESENTATION AND LIQUIDITY
Nature of Operations
MYOS RENS Technology Inc. is an emerging bionutrition and biotherapeutics company focused on the discovery, development and
commercialization of products that improve muscle health and function. The Company was incorporated under the laws of the State of
Nevada on April 11, 2007. On March 17, 2016, the Company merged with its wholly-owned subsidiary and changed its name from MYOS
Corporation to MYOS RENS Technology Inc. As used in these financial statements, the terms “the Company”, “MYOS”, “our”, or “we”,
refers to MYOS RENS Technology Inc. and its subsidiary, unless the context indicates otherwise. On February 25, 2011, the Company
entered into an agreement to acquire the intellectual property for Fortetropin®, our proprietary active ingredient from Peak Wellness, Inc.
The Company’s activities are subject to significant risks and uncertainties.
Our commercial focus is to leverage our clinical data to develop multiple products to target the large, but currently underserved, markets
focused on muscle health. The sales channels through which we sell our products are evolving. The first product we introduced was MYO-
T12, which was sold in the sports nutrition market. MYO T-12 is a proprietary formula containing Fortetropin and other ingredients. The
formula was sold under the brand name MYO T-12 and later as MYO-X through an exclusive distribution agreement with Maximum
Human Performance, or MHP. While the exclusive distribution agreement with MHP terminated in March 2015, MHP continues to
distribute its remaining MYO-X inventories on popular retailer websites and in specialty retailers principally in the U.S. Sales to MHP for
the year ended December 31, 2015 were $57. There were no sales to MHP in 2016 and we do not expect any orders from MHP in 2017.
In February 2014, we expanded our commercial operations into the age management market through a distribution agreement with
Cenegenics Product and Lab Services, LLC (“Cenegenics”), under which Cenegenics distributed and promotes a proprietary formulation
containing Fortetropin through its age management centers and its community of physicians focused on treating a growing population of
patients focused on proactively addressing age-related health and wellness concerns. On November 28, 2014, we entered into a settlement
agreement with Cenegenics wherein we agreed to accept $1,900 by April 2016, (i.e., $300 in the fourth quarter of 2014 and $100 per month
from January 2015 through April 2016) in full satisfaction of Cenegenics’s outstanding obligations with respect to units of product
produced by the Company, including units that had not yet been shipped to Cenegenics at the time of the settlement agreement. In
exchange, we agreed to withdraw our October 10, 2014 request for arbitration before the International Chamber of Commerce. During the
second quarter of 2015, Cenegenics accepted delivery of the remaining units that we were storing on its behalf. Given the settlement
agreement’s extended payment schedule, the Company deferred the revenue and related cost associated with the shipment and recorded the
revenue and cost of sales when the related payment was received in 2016. The distribution agreement with Cenegenics expired in December
2016. As of December 31, 2016 we recognized all of the deferred revenue. We do not expect any orders from Cenegenics in 2017.
During the second quarter of 2015 we launched Rē Muscle HealthTM, our own direct-to-consumer portfolio of muscle health bars, meal
replacement shakes and daily supplement powders each powered by a full 6.6 gram single serving dose of Fortetropin. Our Rē Muscle
Health products are sold through our e-commerce website, remusclehealth.com, and amazon.com.
On March 1, 2017 the Company announced the upcoming launch of Qurr, its Fortetropin®-powered product line formulated to support the
vital role of muscle in overall well-being as well as in fitness. The introduction of Qurr's muscle-focused, natural, over-the-counter products
will make the Qurr line available through convenient direct online ordering without a prescription. All Qurr products are blended with
Fortetropin®, MYOS' proprietary ingredient which has been clinically demonstrated to reduce serum myostatin levels, which helps increase
muscle size and lean body mass. MYOS' earlier product formulations featuring Fortetropin® have become part of the daily routine of many
athletes and fit-conscious people. Qurr is a line of flavored puddings, powders, and shakes all proven to be safe for daily use.
We continue to pursue additional distribution and branded sales opportunities. We expect to continue developing our own core branded
products in markets such as functional foods, sports and fitness nutrition and rehab and restorative health and to pursue international sales
opportunities. There can be no assurance that we will be able to secure distribution arrangements on terms acceptable to the Company, or
that we will be able to generate significant sales of our current and future branded products.
F-8
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2016
(amounts in thousands, except share and per share amounts, unless otherwise indicated)
Strategic Investment Transaction
On December 17, 2015, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with RENS Technology
Inc. (the “Purchaser”), pursuant to which the Purchaser agreed to invest $20.25 million in the Company (the “Financing”) in exchange for
(i) an aggregate of 3,537,037 shares (the “Shares”) of the Company’s common stock, par value $0.001 per share (“Common Stock”), and
(ii) warrants to purchase an aggregate of 884,259 shares of Common Stock (the “Warrants”, and together with the Shares, the “Securities”).
The Purchaser would purchase the Securities in three tranches over twenty-four months. In the first tranche, which closed on March 3,
2016, the Purchaser acquired 1,500,000 Shares and 375,000 Warrants (the “Initial Warrant”) for $5.25 million. In the second tranche,
which would close within six months of the closing of the first tranche, the Purchaser would acquire 925,926 Shares and 231,481 Warrants
(the “Second Warrant”) for $5.0 million. In the third tranche, which was to close within eighteen months of the closing of the second
tranche, the Purchaser will acquire 1,111,111 Shares and 277,778 Warrants (the “Third Warrant”) for $10.0 million. Each of the Warrants
will be immediately exercisable upon issuance, will expire five years after issuance and will have the following exercise prices: (a) $7.00
per share for the Initial Warrant, (b) $10.80 per share for the Second Warrant and (c) $18.00 per share for the Third Warrant. In addition,
the Company agreed: (i) that the Purchaser will have the right to appoint four persons to the Company’s board of directors, subject to
adjustment based on the Purchaser’s ownership percentage of the Company; (ii) to provide the Purchaser with a right to participate in 50%
(or 100% if shares are to be issued for less than $3.50 per share) of any future financings pursued by the Company within 12 months from
the closing of the third tranche of the Financing; and, (iii) until the closing of the third tranche, the Company will not take certain actions,
including issuing shares (except for certain permitted issuances) or appointing new officers and directors, without the Purchaser’s consent.
In addition, on December 17, 2015, the Company issued a convertible note in the amount of $575 to Gan Ren, a related party of RENS
Agriculture. The convertible note provided short-term funding to the Company prior to the closing of the first tranche of the Financing. On
December 17, 2016 the convertible note and accrued interest was converted into 225,860 shares at $2.74 per share. For additional
information on the convertible note with Gan Ren refer to “NOTE 6 – Debt – Convertible Note.”
The first tranche of the Financing was completed on March 3, 2016. The Company used the net proceeds from the first tranche of the
Financing to fund its working capital, product development and marketing, research and development and other general corporate purposes.
On August 19, 2016, the Purchaser notified the Company that it did not intend to fulfill its obligation to fund the second tranche of the
Financing, notwithstanding its confirmation to the Company in June 2016 that the Purchaser would provide such funding in accordance
with the terms of the Purchase Agreement. The Purchase Agreement provides that in the event that the Purchaser notifies the Company that
it does not intend to fund the Second Closing Subscription Amount, the Purchaser is required to take all requisite action to cause the
resignation or removal of one of its designees on the Board of Directors of the Company. Pursuant to the terms of the Purchase Agreement,
effective August 23, 2016, Guiying Zhao resigned as a director of the Company. In addition, the Purchaser’s Rights terminated, effective
August 19, 2016.
On January 6, 2017, the Company commenced an action in the Supreme Court of New York, County of New York, against RENS
Technology, Inc., RENS Agriculture Science & Technology Co., Ltd (“RENS Agriculture”), the parent company of RENS Technology,
and Ren Ren, a principal in both entities and a director of the Company, arising from RENS Technology’s breach of a Securities Purchase
Agreement under which RENS Technology agreed to invest an aggregate of $20.25 million in the Company in exchange for an aggregate
of 3,537,037 shares of common stock of the Company and warrants to purchase an aggregate of 884,259 shares of common stock. In
addition to seeking compensatory, consequential and other damages in the action, the Company asked the Court to preliminarily restrain
RENS Technology and its agents and representatives, including, but not limited to, RENS Agriculture and Ren Ren, from selling,
transferring, conveying, assigning, hypothecating or encumbering 1,500,000 shares of common stock of the Company and a warrant
permitting the purchase of 375,000 shares at a price of $7.00 per share that RENS Technology had purchased under the Securities Purchase
Agreement and, after the parties had an opportunity to submit opposition and reply papers in connection with the Company’s application, a
preliminary injunction prohibiting RENS Technology from selling, transferring, conveying, assigning, hypothecating or encumbering the
1,500,000 shares and warrant during the pendency of the action and an order attaching the stock and warrant to satisfy any judgment entered
in favor of the Company.
On January 11, 2017, the Court granted the Company the preliminary restraints that it requested, which prevents RENS Technology,
among others, from selling, transferring, conveying, assigning, hypothecating or encumbering the 1,500,000 shares of the Company’s
common stock or the aforementioned warrant. The Court scheduled a hearing on February 14, 2017, at which time the Court heard oral
argument on the application for a preliminary injunction and prejudgment attachment of the stock and warrants to satisfy any judgment
entered in favor of the Company. Since then, RENS Technology filed a motion to dismiss the complaint which the Company has opposed.
No decision has been made by the Court on these two pending applications.
F-9
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2016
(amounts in thousands, except share and per share amounts, unless otherwise indicated)
Going Concern
The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles, which
contemplates continuation of the Company as a going concern. The Company has suffered recurring losses from operations and incurred a
net loss of approximately $4,341,000 for the year ended December 31, 2016. As of the filing date of this Form 10-K, management believes
that there may not be sufficient capital resources from operations and existing financing arrangements in order to meet operating expenses
and working capital requirements for the next twelve months, primarily due to the failure of RENS Technology Inc. to fund the required
amounts. These facts raise substantial doubt about the Company’s ability to continue as a going concern.
Accordingly, we are evaluating various alternatives, including reducing operating expenses, securing additional financing through debt or
equity securities to fund future business activities and other strategic alternatives. There can be no assurance that the Company will be able
to generate the level of operating revenues in its business plan, or if additional sources of financing will be available on acceptable terms, if
at all. If no additional sources of financing are available, our future operating prospects may be adversely affected. The financial statements
do not include any adjustments that might result from the outcome of these uncertainties.
NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in
the U.S. (“U.S. GAAP”) and the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). The consolidated
financial information presented herein reflects all normal adjustments that are, in the opinion of management, necessary for a fair statement
of the financial position, results of operations and cash flows for the periods presented. The Company is responsible for the consolidated
financial statements included in this report.
Principles of Consolidation
The accompanying consolidated financial statements include the accounts of MYOS RENS Technology Inc. and its wholly-owned
subsidiary, Atlas Acquisition Corp. All material intercompany balances and transactions have been eliminated.
Reclassification of Prior Year Presentation
Certain prior year amounts have been reclassified for consistency with the current period presentation. These reclassifications did not have
a material impact on the reported results of operations.
Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect
the reported amounts of assets and liabilities, equity and the disclosures of contingent assets and liabilities at the date of the financial
statement and the reported amounts of revenues and expenses during the reporting period. Making estimates requires management to
exercise significant judgment. It is possible that the estimate of the effect of a condition, situation or set of circumstances that existed at the
date of the financial statements, which management considered in formulating its estimate, could change in the near term due to one or
more future non-conforming events. Accordingly, the actual results could differ significantly from estimates. Significant items subject to
such estimates include but are not limited to the valuation of stock-based awards, measurement of allowances for doubtful accounts and
inventory reserves, the selection of asset useful lives, fair value estimations used to test long-lived assets, including intangibles,
impairments and provisions necessary for assets and liabilities.
F-10
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2016
(amounts in thousands, except share and per share amounts, unless otherwise indicated)
The Company has recorded minimal sales to its distributors during the past ten consecutive quarters, and has only recently launched its
QURR portfolio of branded products. Management’s estimates, including evaluation of impairment of long-lived assets and inventory
reserves are based in part on forecasted future results. A variety of factors could cause actual results to differ from forecasted results and
these differences could have a significant effect on asset carrying amounts.
Cash & Cash Equivalents
The Company considers all highly liquid investments purchased with a maturity of three months or less and money market accounts to be
cash equivalents. At December 31, 2016 and 2015, the Company had no cash equivalents.
The Company maintains its bank accounts with high credit quality financial institutions and has never experienced any losses related to
these bank accounts. The Company minimizes its credit risk associated with cash by periodically evaluating the credit quality of its
financial institutions. The balance at times may exceed federally insured limits.
As part of our ongoing liquidity assessments management evaluates our cash, cash equivalents. The amount of funds held in bank can
fluctuate due to the timing of receipts and payments in the ordinary course of business and due to other reasons, such as business-
development activities so the Company may have exposure to cash in excess of FDIC insured limits.
Concentrations of Risk, Significant Customers and Significant Supplier
Management regularly reviews accounts receivable, and if necessary, establishes an allowance for doubtful accounts that reflects
management’s best estimate of amounts that may not be collectible based on historical collection experience and specific customer
information. Expense recognized as a result of an allowance for doubtful accounts is classified under selling, general and administrative
expenses in the Consolidated Statements of Operations. Based primarily on collections, during the year ended December 31, 2015,
management determined that the Cenegenics’ allowance for doubtful accounts should be reduced to $0. Accordingly, a reduction in bad
debt expense of $390 was recorded for the year ended December 31, 2015. There was no such expense recorded in 2016.
At December 31, 2016 and 2015, the Company had the following concentrations of net accounts receivable with customers:
Cenegenics
Direct-to-consumer
Subtotal
Allowance for doubtful accounts
Accounts receivable, net
December 31,
2016
December 31,
2015
$
$
- $
8
8
-
8 $
400
6
406
-
406
For the years ended December 31, 2016 and 2015, the Company had the following concentrations of revenues with customers:
MHP
Cenegenics
December 31,
2016
2015
0%
50%
36%
0%
Inventories, net
Inventories are valued at the lower of cost or market, with cost determined on a first in, first-out basis. Each quarter the Company evaluates
the need for a change in the inventory reserve based on sales and expiration dates of products.
Fixed Assets
Fixed assets are stated at cost and depreciated to their estimated residual value over their estimated useful lives of 3 to 7 years. Leasehold
improvements are amortized over the lesser of the asset's useful life or the contractual remaining lease term including expected renewals.
When assets are retired or otherwise disposed of, the assets and related accumulated depreciation are reversed from the accounts and the
resulting gains or losses are included in the Consolidated Statements of Operations.
Depreciation is provided using the straight-line method for all fixed assets.
F-11
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2016
(amounts in thousands, except share and per share amounts, unless otherwise indicated)
We review our fixed assets for impairment when events or changes in circumstances indicate that the carrying value of an asset may not be
recoverable. We use an estimate of future undiscounted net cash flows of the related assets or groups of assets over their remaining lives in
measuring whether the assets are recoverable. If the assets are determined to be unrecoverable, an impairment loss is calculated by
determining the difference between the carrying values and the estimated fair value. We did not consider any of our fixed assets to be
impaired during the years ended December 31, 2016 and 2015.
Intangible Assets
The Company’s intangible assets consist primarily of intellectual property pertaining to Fortetropin, including its formula, trademarks, trade
secrets, patent application and domain names, which were determined to have a fair value of $2,000 as of December 31, 2011. Based on
expansion into new markets and introduction of new formulas, management determined that the intellectual property had a finite useful life
of ten (10) years and began amortizing the asset over its estimated useful life beginning April 2014.
Based on ten consecutive quarters of minimal revenues combined with changes in the sales channels through which the Company sells its
products and an inability to predict future orders, if any, we tested the intellectual property for impairment in the fourth quarter of 2016 and
determined that the asset value was recoverable and therefore no impairment was recognized.
We had impairment losses recorded during the years ended December 31, 2016 and 2015 of $44 and $-0-, respectively.
In July 2014, the Company acquired the United States patent application for the manufacture of Fortetropin from Deutsches Institut fur
Lebensmitteltechnik e.V. - the German Institute for Food Technologies (“DIL”). The cost of the patent application, which was capitalized
as an intangible asset, was determined to be $101, based on the present value of the minimum guaranteed royalty payable to DIL using a
discount rate of 10%. The intangible asset is being amortized over an estimated useful life of ten (10) years. The remaining contingent
royalty payments will be recorded as the contingency is resolved and the royalty becomes payable under the arrangement. For additional
information on the amended supply agreement with DIL refer to “NOTE 12 – Commitments and Contingencies - Supply Agreement.”
Intangible assets also includes patent costs associated with applying for a patent and being issued a patent. Costs to defend a patent and
costs to invalidate a competitor’s patent or patent application are expensed as incurred. Upon issuance of the patent, capitalized patent costs
are reclassified from intangibles with indefinite lives to intangibles with finite lives and amortized on a straight-line basis over the shorter
of the estimated economic life or the initial term of the patent, generally 20 years. During the years ended December 31, 2016 and 2015,
the Company recorded impairment losses of $44 and $0, respectively. The impairment losses were related to the write-off of capitalized
patent costs due to the unlikelihood of certain patents being issued.
Intangible assets at December 31, 2016 and December 31, 2015 consisted of the following:
(In thousand $)
Intangibles with finite lives:
Intellectual property
Website - qurr.com
Less: accumulated amortization
Total intangibles with finite lives:
Intangibles with indefinite lives:
Patent costs
Less: impairment charge on patent costs
Total intangibles with indefinite lives:
Total intangible assets, net
December 31, December 31,
2016
2015
$
$
2,101 $
380
(574)
1,907
44
(44)
-
1,907 $
2,101
-
(365)
1,736
44
-
44
1,780
Assuming no additions, disposals or adjustments are made to the carrying values and/or useful lives of the intangible assets, annual
amortization expense for intangible assets is estimated to be $210 in each of the next five years.
F-12
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2016
(amounts in thousands, except share and per share amounts, unless otherwise indicated)
Impairment testing of intangible assets subject to amortization involves comparing the carrying amount of the asset to the forecasted
undiscounted future cash flows whenever events or changes in circumstances indicate that the carrying amount of the asset may not be
recoverable. In the event the carrying value of the asset exceeds the undiscounted future cash flows, the carrying value is considered not
recoverable and an impairment exists. An impairment loss is measured as the excess of the asset’s carrying value over its fair value,
calculated using a discounted future cash flow method. The computed impairment loss is recognized in the period that the impairment
occurs. Assets which are not impaired may require an adjustment to the remaining useful lives for which to amortize the asset. Impairment
testing requires the development of significant estimates and assumptions involving the determination of estimated net cash flows,
selection of the appropriate discount rate to measure the risk inherent in future cash flow streams, assessment of an asset’s life cycle,
competitive trends impacting the asset as well as other factors. Changes in these underlying assumptions could significantly impact the
asset’s estimated fair value.
Revenue Recognition
The Company records revenue from product sales when persuasive evidence of an arrangement exists, product has been shipped or
delivered, the sales price to the customer is fixed or determinable, and collectability is reasonably assured. Product sales represent revenue
from the sale of products and related shipping amounts billed to customers, net of promotional discounts, rebates, and return allowances.
Depending on individual customer agreements, sales are recognized either upon shipment of product to customers or upon delivery. With
respect to direct-to-consumer sales, both title and risk of loss transfer to customers upon our delivery to the customer. The Company’s gross
product sales may be subject to sales allowances and deductions in arriving at reported net product sales. For example, we may periodically
offer discounts and sales incentives to customers to encourage purchases. Sales incentives are treated as a reduction to the purchase price of
the related transaction. Reductions from gross sales for customer discounts and rebates have been minimal, and sales allowances for
product returns have not been provided, since under our existing arrangements, customers are not permitted to return product except for
non-conforming product.
Advertising
The Company charges the costs of advertising to selling, general and administrative expenses as incurred. Advertising and promotional
costs were $172 and $247 for the years ended December 31, 2016 and 2015, respectively. For the year ended December 31, 2016,
advertising and promotional costs consisted primarily of marketing costs for our Rē Muscle Health products, and for the year ended
December 31, 2015, advertising and promotional costs consisted primarily of co-operative advertising fees payable to MHP. Pursuant to the
distribution agreement with MHP, which terminated in March 2015, the Company paid MHP for co-operative advertising.
Research and Development
Research and development expenses consist primarily of salaries, benefits, and other related costs, including stock-based compensation, for
personnel serving in our research and development functions, and other internal operating expenses, the cost of manufacturing our product
for clinical study, the cost of conducting clinical studies and the cost of conducting preclinical and research activities. Nonrefundable
advance payments for goods or services that will be used or rendered for future research and development activities are initially capitalized
and are then recognized as an expense as the related goods are consumed or the services are performed. During the years ended December
31, 2016 and 2015, the Company incurred research and development expenses of $-0- and $858 respectively.
Shipping and Handling Costs
The Company records costs for shipping and handling of products to our customers in cost of sales. These expenses were $10 and $10 for
the years ended December 31, 2016 and 2015, respectively.
Stock-based Compensation
Stock-based payments are measured at their estimated fair value on the date of grant. Stock-based awards to non-employees are re-
measured at fair value each financial reporting date until performance is completed. Stock-based compensation expense recognized during
a period is based on the estimated number of awards that are ultimately expected to vest. For stock options and restricted stock that do not
vest immediately but which contain only a service vesting feature, we recognize compensation cost on the unvested shares and options on a
straight-line basis over the remaining vesting period.
The Company uses the Black-Scholes option-pricing model to estimate the fair value of options and the market price of our common stock
on the date of grant for the fair value of restricted stock issued. Our determination of fair value of stock-based awards is affected by our
stock price as well as assumptions regarding a number of highly complex and subjective variables. These variables include, but are not
limited to, our expected stock price volatility over the term of the awards, and certain other market variables such as the risk-free interest
rate.
F-13
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2016
(amounts in thousands, except share and per share amounts, unless otherwise indicated)
Segment Information
Accounting Standards Codification (“ASC”) 280, Disclosures about Segments of an Enterprise and Related Information, establishes
standards for reporting information about operating segments and requires selected information for those segments to be presented in the
financial statements. It also establishes standards for related disclosures about products and services and geographic areas. Operating
segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the
chief operating decision maker, or decision-making group, in making decisions how to allocate resources and assess performance.
Management has determined that the Company operates in one segment.
Fair Value Measurement
Fair value is the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between
market participants. The authoritative guidance on fair value measurements establishes a consistent framework for measuring fair value on
either a recurring or nonrecurring basis whereby observable and unobservable inputs, used in valuation techniques, are assigned a
hierarchical level.
The following are the hierarchy levels of inputs to measure fair value:
Level 1:
Level 2:
Level 3:
Inputs that utilize quoted prices (unadjusted) in active markets for identical assets or liabilities.
Inputs that utilize observable quoted prices for similar assets and liabilities in active markets and observable quoted prices for
identical or similar assets in markets that are not very active.
Inputs that utilize unobservable inputs and include valuations of assets or liabilities for which there is little, if any, market
activity.
A financial asset or liability’s classification within the above hierarchy is determined based on the lowest level input that is significant to
the fair value measurement. At December 31, 2016 and 2015, the Company’s financial instruments consist primarily of cash and cash
equivalents, accounts receivable, accounts payable and accrued expenses and short-term debt. Due to their short-term nature, the carrying
amounts of the Company’s financial instruments approximated their fair values.
Basic and Diluted Loss Per Share
Basic net loss per share is computed by dividing net loss available to common stockholders for the period by the weighted average number
of common shares outstanding during the period. Diluted net loss per share is computed by dividing net loss for the period by the weighted
average number of common shares outstanding during the period increased to include the number of additional shares of common stock
that would have been outstanding if potential dilutive securities outstanding had been issued. The Company uses the “treasury stock”
method to determine the dilutive effect of common stock equivalents such as options, warrants and restricted stock. For the years ended
December 31, 2016 and 2015, the Company incurred a net loss.
Accordingly, the Company’s common stock equivalents were anti-dilutive and excluded from the diluted net loss per share computation.
The aggregate number of potentially dilutive common stock equivalents outstanding at December 31, 2016 excluded from the diluted net
loss per share computation because their inclusion would be anti-dilutive were 1,449,308, which includes warrants to purchase an aggregate
1,136,878 shares of common stock, options to purchase an aggregate of 300,340 shares of common stock, and unvested restricted stock
awards of 53,857 shares of common stock.
The aggregate number of potentially dilutive common stock equivalents outstanding at December 31, 2015 excluded from the diluted net
loss per share computation because their inclusion would be anti-dilutive were 1,632,963, which includes up to 193,865 Make-Whole
Shares (See NOTE 9 – Warrants), warrants to purchase an aggregate 761,878 shares of common stock, options to purchase an aggregate of
400,545 shares of common stock and unvested restricted stock awards of 18,450 shares of common stock.
Income Taxes
Income taxes are accounted for under the asset and liability method in accordance with ASC 740, Accounting for Income Taxes (“ASC
740”). Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial
carrying amounts of existing assets and liabilities and their respective tax bases as well as operating loss and tax credit carry forwards.
Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the periods in which those
temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is
recognized in income in the period that includes the enactment date. Deferred tax assets are reduced by a valuation allowance to the extent
that the recoverability of the asset is unlikely to be recognized. The Company follows ASC 740 rules governing uncertain tax positions,
which provides guidance for recognition and measurement. This prescribes a threshold condition that a tax position must meet for any of
the benefits of the uncertain tax position to be recognized in the financial statements. It also provides accounting guidance on recognition,
classification and disclosure of these uncertain tax positions. The Company has no uncertain income tax positions.
Interest costs and penalties related to income taxes are classified as interest expense and operating expenses, respectively, in the Company's
financial statements. For the years ended December 31, 2016 and 2015, the Company did not recognize any interest or penalty expense
related to income taxes. The Company files income tax returns in the U.S. federal jurisdiction and states in which it does business.
F-14
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2016
(amounts in thousands, except share and per share amounts, unless otherwise indicated)
NOTE 3 – RECENT ACCOUNTING PRONOUNCEMENTS
In January 2017, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) No. 2017-04,
Simplifying the Test for Goodwill, which accomplishes exactly what its title indicates by eliminating the second step in the current
goodwill impairment calculation. Currently there is a two-step process for determining the amount of any goodwill impairment. In Step 1
an entity determines if the carrying value of the reporting unit (for which goodwill has been recorded) exceeds the fair value of the
reporting unit. If the calculation in Step 1 indicates that the carrying value of a reporting unit for which goodwill has been recorded exceeds
the fair value, the entity would have to determine the implied fair value of the reporting unit’s goodwill. An impairment would be recorded
to the extent that the goodwill carrying value exceeded the implied fair value of goodwill at the reporting date. The amount of any
goodwill impairment must take into consideration the effects of income taxes for any tax deductible goodwill. The effective date to adopt
the ASU is for fiscal years beginning after December 15, 2019. The ASU is to be applied prospectively. Early adoption is permitted. The
Company has evaluated the impact of the updated guidance and has determined that the adoption of ASU 2017-04 is not expected to have a
significant impact on its consolidated financial statements.
In August 2016, the FASB issued ASU 2016-15, “Classification of Certain Cash Receipts and Cash Payments (a consensus of the
Emerging Issues Task Force).” The amendments in this Update relate to eight specific types of cash receipts and cash payments which
current GAAP either is unclear or does not include specific guidance on the cash flow classification issues. The amendments in this Update
are effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years.
Early adoption is permitted, including adoption in an interim period. If an entity early adopts the amendments in an interim period, any
adjustments should be reflected as of the beginning of the fiscal year that includes that interim period. An entity that elects early adoption
must adopt all of the amendments in the same period. The Company will adopt the provisions of this ASU for its fiscal year beginning
January 1, 2017. The adoption of ASU 2016-15 does not expect to have a significant impact on its consolidated financial statements.
In May 2016, the FASB issued ASU 2016-12, “Revenue from Contracts with Customers (Topic 606), Narrow Scope Improvements and
Practical Expedients.” The amendments in ASU 2016-12 affect only the narrow aspects of Topic 606 that are outlined in ASU 2016-12.
The effective date and transition requirements for the amendments in this Update are the same as the effective date and transition
requirements of Update 2015-14, which is discussed above. The Company has evaluated the impact of the updated guidance and has
determined that the adoption of ASU 2016-12 is not expected to have a significant impact on its consolidated financial statements.
In April 2016, the FASB issued ASU 2016-10 “Revenue from Contracts with Customers: Identifying Performance Obligations and
Licensing.” The amendments in this Update affect entities with transactions included within the scope of Topic 606. The scope of that
Topic includes entities that enter into contracts with customers to transfer goods or services (that are an output of the entity’s ordinary
activities) in exchange for consideration. The effective date and transition requirements for the amendments in this Update are the same as
the effective date and transition requirements of Update 2015-14, which is discussed above. The Company has evaluated the impact of the
updated guidance and has determined that the adoption of ASU 2016-10 is not expected to have a significant impact on its consolidated
financial statements.
F-15
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2016
(amounts in thousands, except share and per share amounts, unless otherwise indicated)
In March 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) No. 2016-09,
Compensation – Stock Compensation (Topic 718): Improvements to Employee share-Based Payment Accounting (ASU 2016-09”). ASU
216-09 provides guidance designed to simplify several aspects of the accounting for share-based payment transactions, including guidance
relating to accounting for income taxes with respect to share-based payment awards; providing generally that excess tax benefits related to
share-based awards should be recorded as a reduction to income tax expense (currently, excess tax benefits generally are recorded to
additional-paid-in-capital); providing generally that excess tax benefits related to share-based awards should be classified along with other
income tax cash flows as an operating activity (currently, excess tax benefits generally are separated from other income tax cash flows and
classified as a financing activity); providing that an entity may make an accounting policy election either to base compensation cost accruals
on the number of awards expected to vest (as required by current guidance) or to account for forfeitures when they occur; modifying the
current exception to liability classification such that partial cash settlement of an award for tax withholding purposes would not result, by
itself, in liability classification of the award if the amount withheld does not exceed the maximum statutory tax rate in the employees'
applicable jurisdictions (currently, an award cannot qualify for equity classification, rather than liability classification, if the amount
withheld exceeds the minimum statutory withholding requirements); and providing that cash paid by an employer when directly
withholding shares for tax withholding purposes should be classified as a financing activity on the statement of cash flows (currently there
is no authoritative guidance addressing this classification issue). The guidance is effective for fiscal years, and interim periods within those
fiscal years, beginning after December 15, 2016. Early adoption is permitted (if early adoption occurs in an interim period, any adjustments
will be reflected as of the beginning of the fiscal year that includes the interim period). Depending on the particular issue addressed by the
guidance, application of the guidance will be made prospectively, retrospectively or subject to a retrospective transition method. We are
currently evaluating the potential impact of adopting this guidance on the Company's results of operations, cash flows and financial
position.
In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) No. 2016-02, Leases
(Topic 842) (“ASU 2016-02”), which requires lessees to recognize on the balance sheet the assets and liabilities for the rights and
obligations created by leases with lease terms of more than 12 months. The recognition, measurement, and presentation of expenses and
cash flows arising from a lease by a lessee will continue to primarily depend on its classification as a finance or operating lease. However,
unlike current accounting principles generally accepted in the U.S. (“U.S. GAAP”), which requires only capital leases to be recognized on
the balance sheet, ASU 2016-02 will require both types of leases to be recognized on the balance sheet. ASU 2016-02 also requires
disclosures about the amount, timing, and uncertainty of cash flows arising from leases. These disclosures include qualitative and
quantitative requirements, providing additional information about the amounts recorded in the financial statements. ASU 2016-02 is
effective for us beginning January 1, 2019, with early application permitted. We are currently evaluating the effect that the updated
standard will have on our consolidated financial statements.
In November 2015, the FASB issued ASU No. 2015-17, Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes
(“ASU 2015-17”) ASU 2015-17requires that deferred tax assets and liabilities be classified as noncurrent in a classified statement of
financial position. The amendments in this Update may be applied either prospectively to all deferred tax liabilities and assets or
retrospectively to all periods presented and is effective for periods beginning after December 15, 2016. The Company has evaluated the
impact of the updated guidance and has determined that the adoption of ASU 2015-17 does not expect to have a significant impact on its
consolidated financial statements.
In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory (“ASU 2015-11”),
which changes the measurement principle for inventory from the lower of cost or market to the lower of cost and net realizable value. ASU
2015-11 defines net realizable value as estimated selling prices in the ordinary course of business, less reasonably predictable costs of
completion, disposal, and transportation. The new guidance must be applied on a prospective basis by us beginning January 1, 2017, with
early adoption permitted. The Company has evaluated the impact of the updated guidance and has determined that the adoption of ASU
2015-17 is not expected to have a significant impact on its consolidated financial statements.
In April 2015, the FASB issued ASU No. 2015-03, “Simplifying the Presentation of Debt Issuance Costs” (“ASU 2015-03”), which
requires all debt issuance costs be presented in the balance sheet as a direct deduction from the carrying value of the associated debt. Prior
to the issuance of this standard, debt issuance costs, which are specific incremental costs, other than those paid to the lender, that are
directly attributable to issuing a debt instrument (i.e., third party costs), were required to be presented in the balance sheet as a deferred
charge (i.e., an asset). Under ASU 2015-03, the presentation of debt issuance costs is consistent with the presentation for a debt discount,
(i.e., a direct adjustment to the carrying value of the debt). ASU 2015-03 does not affect the recognition and measurement of debt issuance
costs. Accordingly, the amortization of such costs should continue to be calculated using the interest method and be reported as interest
expense. ASU 2015-03 is effective for us beginning January 1, 2016. The Company has evaluated the impact of the updated guidance and
has determined that the adoption of ASU 2015-03 does not expect to have an impact on its consolidated financial statements and related
disclosures.
F-16
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2016
(amounts in thousands, except share and per share amounts, unless otherwise indicated)
In August 2014, the FASB issued ASU No. 2014-15, “Presentation of Financial Statements – Going Concern (Subtopic 205-40):
Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern” (“ASU 2014-15”). The amendments in this update
define management’s responsibility to evaluate whether there is substantial doubt about an organization’s ability to continue as a going
concern and provides related footnote disclosure requirements. Under U.S. GAAP, financial statements are prepared under the presumption
that the reporting organization will continue to operate as a going concern, except in limited circumstances. Financial reporting under this
presumption is commonly referred to as the going concern basis of accounting. The going concern basis of accounting establishes the
fundamental basis for measuring and classifying assets and liabilities. This update provides guidance on when there is substantial doubt
about an organization’s ability to continue as a going concern and how the underlying conditions and events should be disclosed in the
footnotes. It is intended to reduce diversity that existed in footnote disclosures because of the lack of guidance about when substantial doubt
existed. The amendments in this update are effective for us beginning December 31, 2016. Early application is permitted. The Company
has evaluated the impact of the updated guidance and has disclosed the impact in the footnotes on its consolidated financial statements
In May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers” (“ASU 2014-09”). ASU 2014-09 supersedes
nearly all existing revenue recognition guidance under U.S. GAAP and requires revenue to be recognized when promised goods or services
are transferred to customers in an amount that reflects the consideration that is expected to be received for those goods or services.
Additionally, qualitative and quantitative disclosures are required about customer contracts, significant judgments and changes in
judgments, and assets recognized from the costs to obtain or fulfill a contract. This accounting guidance is effective for us beginning
January 1, 2018 using one of two prescribed transition methods. We are currently evaluating the effect that the updated standard will have
on our consolidated financial statements and related disclosures.
NOTE 4 – INVENTORIES, NET
Inventories, net at December 31, 2016 and 2015 consisted of the following:
(In thousand $)
Raw materials
Work in process
Finished goods
Less: inventory reserves
Inventories, net
NOTE 5 – FIXED ASSETS
Fixed assets at December 31, 2016 and 2015 consisted of the following:
(In thousand $)
Furniture, fixtures and equipment
Computers and software
Leasehold improvements
Other
Total fixed assets
Less: accumulated depreciation and amortization
Net book value of fixed assets
December 31,
2016
December 31,
2015
$
$
2,378 $
5
188
2,571
(709)
1,862 $
1,997
1
167
2,165
(698)
1,467
December 31,
2016
December 31,
2015
$
$
116 $
66
239
7
428
(195)
233 $
116
66
239
7
428
(141)
287
Depreciation and amortization expense was $54 and $53 for the years ended December 31, 2016 and 2015, respectively. Repairs and
maintenance costs are expensed as incurred.
NOTE 6 – DEBT
Convertible Note
On December 17, 2015, concurrent with the execution of the Purchase Agreement with RENS Technology Inc., the Company issued an
unsecured promissory note in the principal amount of $575 (the “Note”) to Gan Ren, a related party of RENS Agriculture. The Note
accrued interest at a rate of 8% per annum and matured on December 17, 2016. On December 17, 2016, the Note and accrued interest of
$46 were automatically converted into 225,864 shares of Common Stock at $2.75 per share.
F-17
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2016
(amounts in thousands, except share and per share amounts, unless otherwise indicated)
Term Note
On September 10, 2015, the Company converted its outstanding revolving note with City National Bank, which had a termination date of
August 31, 2015, into a term note (the “Term Note”). The Term Note provided that the then outstanding balance of $400 shall be payable
along with interest thereon on the last day of each month in four (4) consecutive installments of $100, with the final installment due and
payable in full on December 31, 2015. The Term Note was collateralized by all inventory, chattel paper, accounts, equipment, general
intangibles, securities and instruments and contained customary events of default, including failure to make payment and bankruptcy. As of
December 31, 2015, the interest rate on the Term Note was 4.50%. At December 31, 2015, the balance under the Term Note was $100,
which was subsequently paid in full on January 7, 2016.
NOTE 7 - PREPAID EXPENSES, ACCRUED EXPENSES, OTHER CURRENT ASSETS AND LIABILITIES
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consist of various payments that the Company has made in advance for goods or services to be
received in the future. Prepaid expenses and other current assets at December 31, 2016 and 2015 consisted of the following:
(In thousand $)
Prepaid insurance
Prepaid inventory purchases
Deferred charges(1)
Other
Total prepaid expenses and other current assets
December 31,
2016
December 31,
2015
$
$
27 $
1
-
57
85 $
32
250
217
24
523
(1) Deferred charges at December 31,2015 includes $153 related to the cost of inventory shipped to Cenegenics in May 2015 where revenue
was deferred until payment of the commensurate sale was received and recognized in 2016 and deferred financing costs of $65 related to
the Financing. The Financing cost were reclassified to additional paid-in capital during the first quarter of 2016, upon consummation of
the first tranche of the Financing.
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consist of estimated future payments that relate to the current and prior accounting periods.
Management reviews these estimates regularly to determine their reasonableness. Accrued expenses and other current liabilities at
December 31, 2016 and 2015 consisted of the following:
(In thousand $)
Advertising and promotional expense payable
Professional fees
Deferred rent
Deferred revenue(1)
Research & development
Accrued salaries & bonuses
Consulting fees
Other accrued expenses
Total accrued expenses
December 31,
2016
December 31,
2015
$
$
171 $
88
40
56
-
15
47
-
417 $
171
64
47
228
30
151
2
24
717
(1) Deferred revenue represents revenue to be recognized in the future in connection with inventory shipped. In October 2016 we received a
purchase order along with $56 in cash. The sale was deferred as product was shipped in 2017. In May 2015 revenue for a sale to
Cenegenics was deferred until the cash was collected in January 2016 and recognized for the shipment made under a settlement
agreement with Cenegenics that included extended payment terms.
F-18
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2016
(amounts in thousands, except share and per share amounts, unless otherwise indicated)
NOTE 8 - STOCKHOLDERS’ EQUITY
Preferred Stock Rights
Effective February 14, 2017, the Board of Directors declared a dividend of one right for each of the Company’s issued and outstanding
shares of common stock, $0.001 par value per share. The dividend was paid to the stockholders of record at the close of business on
February 24, 2017. Each Right entitles the registered holder, upon the occurrence of certain events specified in the Rights Agreement to
purchase from the Company one one-thousandth of a share of the Company’s Series A Preferred Stock at a price of $7.00, subject to certain
adjustments. The description and terms of the Rights are set forth in the Rights Agreement dated as of February 14, between the Company
and Island Stock Transfer, as Rights Agent.
Increase in Number of Authorized Shares
On March 8, 2016, the Company filed a Certificate of Amendment to its Articles of Incorporation with the Secretary of State of the State of
Nevada to increase the number of authorized shares of common stock. As a result of the amendment, the number of the Company’s
authorized shares of common stock increased from 8,000,000 to 12,000,000.
Issuance of Common Stock
The Company has periodically issued common stock in connection with certain private and public offerings. For the years ended December
31, 2016 and 2015, the Company has received aggregate gross proceeds of $6,251 from these offerings as follows:
(In thousand $)
Date
May 18, 2015
November 30, 2015
March 6, 2016
Shares
Proceeds
Gross
190,609(1)
193,865(2)
1,500,000(3)
$
1,884,474
1,001
-
5,250
6,251
(1) Shares issued pursuant to Warrant Exercise Agreements with certain holders of the Series D warrants.
(2) Shares issued pursuant to Make-Whole Shares provision of the November 2014 registered offering.
(3) Shares issued pursuant to the closing of the first tranche of the Financing with RENS Technology Inc. on March 3, 2016.
NOTE 9 – WARRANTS
On May 18, 2015, the Company entered into Warrant Exercise Agreements with certain holders of outstanding Series D warrants to
purchase an aggregate of 190,609 shares of common stock in the Company (the “Agreements”). Pursuant to the terms of the Agreements,
the exercise price of the Series D Warrants exercised was reduced, immediately prior to their exercise, from $9.37 per share to $5.25 per
share in exchange for the immediate cash exercise of such warrants. In addition, the Company agreed to (a) reduce the exercise price of its
outstanding Series C Warrants from $12.00 per share to $9.00 per share and (b) reduce the exercise price of its outstanding Series E
Warrants, which are exercisable only if the Series D Warrants are exercised, from $15.00 per share to $9.00 per share. The Company
received aggregate gross proceeds of $1,001, or $916 net of cash fees of $85, from the cash exercise of the Series D Warrants. The
Company accepted any and all Series D Warrants properly exercised at $5.25 per share, in accordance with the terms of the Series D
Warrants, by May 21, 2015. Except for the changes set forth above, the terms of the Company’s outstanding warrants remain unchanged.
The incremental fair value (i.e., the change in the fair value of the warrants before and after reducing the exercise price) determined using a
Black-Scholes option pricing model was $38, $136 and $51 for the Series C Warrants, Series D Warrants and Series E Warrants,
respectively. The amount of $225 in aggregate, was recorded in additional paid-in capital, since the modified warrants were initially
classified within equity and remained classified within equity after the warrant modification. The Company also reflected the amount as an
allocation against net loss attributable to common shareholders in the computation of earnings per share, even though there is no impact to
net loss, based on the guidance in ASC No. 260-10, Earnings per Share (Subtopic S99-3). The following table summarizes the assumptions
used to calculate the incremental fair value of the warrants:
Expected volatility
Risk-free interest rate
Expected term in years
Expected dividend yield
96%-227%
0.02%-1.87%
0.0-7.0
0%
F-19
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2016
(amounts in thousands, except share and per share amounts, unless otherwise indicated)
The risk-free rate is based on the U.S. Treasury rate for a note with a similar term in effect at the time of the grant. The expected volatility
is based on the volatility of the Company’s historical stock price.
At May 18, 2015, the modified Series C Warrants and Series E Warrants were determined to have an estimated aggregate fair value of $569
and $653, respectively. A total of 3,256 Series D Warrants not presented for exercise by May 21, 2015 expired unexercised, along with
2,442 Series E Warrants, which did not become exercisable since the related Series D Warrants were not exercised.
On March 3, 2016, the Company completed the first tranche of the Financing, pursuant to which the Purchaser acquired a warrant to
purchase 375,000 shares of common stock. The warrant is immediately exercisable upon issuance, will expire five years after issuance and
has an exercise price of $7.00 per share. The First Closing Warrant was determined to have an estimated aggregate fair value of $480 at
issuance.
The following table summarizes information about outstanding and exercisable warrants at December 31, 2016:
Shares
Underlying
Warrants
Shares
Number of Underlying Outstanding
Shares
Warrants
and
Description
Series A(1)
Series B(1)
Series C(2)
Series D(2)
Series E(2)
Rens(3)
Grant Date
January 27, 2014
January 27, 2014
November 19, 2014
November 19, 2014
November 19, 2014
March 3, 2016
December 31, Exercise
Expiration
Term
in years
Price
at
or
2016
315,676
157,846
145,399
Underlying Exchanged, Exercisable
Warrants Exercised
Originally
Granted Expired
-
-
(142,957)
142,957
(193,865)
(145,399)
142,957
-
(196,307)
315,676 $
157,846 $
2,442 $
142,957 $
-
-
142,957 $
375,000 $
1,136,878
375,000
1,333,185
193,865
145,399
15.00
45.00
12.00
9.00
N/A
N/A
9.00
7.00
.08
2.07
3.38
3.38
N/A
N/A
5.38
2.31
(1) Issued in connection with the January 27, 2014 private placement transaction.
(2) Issued in connection with the November 19, 2014 registered-direct public offering, and subsequently revised pursuant to Warrant
Exercise Agreements entered into on May 18, 2015.
(3) Shares issued pursuant to the closing of the first tranche of the Financing with RENS Technology Inc. on March 3, 2016.
F-20
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2016
(amounts in thousands, except share and per share amounts, unless otherwise indicated)
The following table summarizes the activities in warrants for the years ended December 31, 2016 and 2015:
Balance at December 31, 2014
Warrants exercised
Warrants expired
Balance at December 31, 2015
Warrants granted
Balance at December 31, 2016
Shares
Underlying
Warrants
Average
Exercise
Price
958,185 $
(190,609)
(5,698)
761,878 $
375,000
1,136,878 $
18.35
5.25
12.59
18.95
2.31
15.01
The following table summarizes the assumptions used to value the warrants at the issuance date using the Black-Scholes option pricing
model:
Number
of
Shares
Underlying Price on
Stock
Grant /
Modification Warrants Measurement Exercise Expected Expected
Term Volatility
Price
Date
Dividend
Yield
Risk Free
Rate
Description
Series A
Series B
Series C
Repricing Series C
Series D
Repricing Series D
Series E
Repricing Series E
Rens Technology
Date
1/27/2014
1/27/2014
11/19/2014
5/18/2015
11/19/2014
5/18/2015
11/19/2014
5/18/2015
3/3/2016
Granted
315,676 $
157,846 $
145,399 $
142,957 $
193,865 $
190,609 $
145,399 $
142,957 $
375,000 $
7.00 $
7.00 $
9.37 $
5.95 $
9.37 $
5.95 $
9.37 $
5.95 $
7.00 $
15.00
45.00
12.00
9.00
9.37
5.25
15.00
9.00
7.00
3.00
5.00
5.50
5.00
0.50
0.00
7.50
7.00
4.00
150.00%
150.00%
94.60%
96.34%
93.44%
226.56%
94.60%
96.34%
96.34%
0.00%
0.00%
0.00%
0.00%
0.00%
0.00%
0.00%
0.00%
0.00%
0.76%
1.61%
1.64%
1.46%
0.07%
0.02%
1.64%
1.87%
1.87%
NOTE 10 - STOCK COMPENSATION
Equity Incentive Plan
The Company increased the number of shares available for issuance under its 2012 Equity Incentive Plan (as amended, the “Plan”) from
550,000 to 850,000 in November 2016, which was approved by the Company’s shareholders in December 2016. The plan provides for the
issuance of up to 850,000 shares. The Plan provides for grants of stock options, stock appreciation rights, restricted stock, other stock-based
awards and other cash-based awards. As of December 31, 2016, the remaining shares of common stock available for future issuances of
awards was 543,606. The Company granted an aggregate of 30,000 options to purchase restricted common stock to certain directors prior
to the adoption of the Plan.
Stock options generally vest and become exercisable with respect to 100% of the common stock subject to such stock option on the third
(3rd) anniversary of the date of grant. Any unvested portion of a stock option shall expire upon termination of employment or service of
the participant granted the stock option, and the vested portion shall remain exercisable in accordance with the provisions of the Plan.
F-21
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2016
(amounts in thousands, except share and per share amounts, unless otherwise indicated)
Stock Options
The following table summarizes stock option activity for the years ended December 31, 2016 and 2015:
Weighted
Shares
Under
Options
Weighted Average
Average
Exercise
Remaining
Contractual
Term (Years)
8.50
Price
Balance at December 31, 2014
Options granted
Options cancelled
Options forfeited
Balance at December 31, 2015
Options cancelled
Options forfeited
367,080 $
108,000
(38,940)
(35,595)
400,545 $
(65,455)
(34,750)
300,340 $
14.68
12.50
12.50
12.03
14.56
13.14
12.51
15.09
7.82
6.71
The weighted average grant date fair value of stock options granted during 2015 was $5.22. The following table summarizes the
assumptions used to value stock options granted in 2015 using a Black-Scholes model:
Risk-free interest rate
Expected volatility
Weighted average expected volatility
Expected term (years)
Expected dividend yield
2015
1.39%-1.69%
98%
98%
5.8-6.3
0%
The risk-free rate is based on the U.S. Treasury rate for a note with a similar term in effect at the time of the grant. The expected volatility
is based on the volatility of the Company’s historical stock prices.
At December 31, 2016 and 2015, the exercisable options had no intrinsic value.
F-22
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2016
(amounts in thousands, except share and per share amounts, unless otherwise indicated)
The following table summarizes information about options outstanding and exercisable at December 31, 2016 that were granted under the
Plan:
Options Outstanding
Options Exercisable
Options
Weighted Average
Remaining
Outstanding
Contractual Life
Exercise
Price
Options
Exercisable
Exercise
Price
$
$
$
$
$
$
$
$
$
$
$
$
7.00
8.60
10.00
11.00
12.10
12.50
13.45
13.50
13.75
17.50
32.00
34.50
5,000
22,000
5,040
3,000
30,500
94,800
2,000
12,000
6,000
100,000
15,000
5,000
300,340
5.40 $
7.19 $
6.11 $
6.02 $
7.35 $
7.42 $
7.47 $
7.49 $
7.67 $
6.11 $
4.54 $
4.57 $
7.00
8.60
10.00
11.00
12.10
12.50
13.45
13.50
13.75
17.50
32.00
34.50
Weighted Average
Remaining
Contractual Life
5.40
7.19
6.11
6.02
7.35
6.94
7.47
7.49
7.67
6.11
4.54
4.57
5,000
22,000
5,040
3,000
30,500
53,050
1,000
6,000
6,000
100,000
15,000
5,000
251,590
As of December 31, 2016, 251,590 options have vested and 48,750 options remain unvested. The vesting terms range from zero to 4.5
years and the vested options have a weighted average remaining term of 6.7 years and a weighted average exercise price of $15.09 per
share.
F-23
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2016
(amounts in thousands, except share and per share amounts, unless otherwise indicated)
Restricted Stock
The following table summarizes restricted stock awards activity for the years ended December 31, 2016 and 2015:
Shares
Restricted stock awards unvested at December 31, 2014
Granted
Vested
Forfeited
Restricted stock awards unvested at December 31, 2015
Granted
Vested
Forfeited
Restricted stock awards unvested at December 31, 2016
Weighted
Average
Grant Date
Share Price
14.95
2.73
4.91
7.50
9.09
2.08
5.40
2.27
2.74
22,200 $
66,099
(68,849)
(1,000)
18,450 $
70,639
(30,232)
(5,000)
53,857 $
At December 31, 2016, the weighted-average remaining vesting period of unvested restricted stock awards was 2.74 years.
Stock-Based Compensation:
Stock-based compensation was $392 and $931 for the years ended December 31, 2016 and 2015, respectively. Stock-based compensation
consists of expenses related to the issuance of stock options and restricted stock.
The aggregate unrecognized compensation expense of stock options and restricted stock at December 31, 2016 was $251, which will be
recognized through January 2019.
NOTE 11 - INCOME TAXES
Income tax expense for the years ended December 31, 2016 and 2015 is shown as follows:
(In thousand $)
Current provision
Deferred provision
Total tax provision (benefit)
December 31, December 31,
2016
2015
$
$
- $
-
- $
2
-
2
F-24
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2016
(amounts in thousands, except share and per share amounts, unless otherwise indicated)
The significant components of the Company's deferred tax assets and liabilities at December 31, 2016 and 2015 are as follows:
(In thousand $)
Federal net operating losses
State net operating losses
Stock options
Federal tax credit
Amortization
Depreciation
Contributions
Other
Total gross deferred tax assets/(liabilities)
Less valuation allowance
Net deferred tax assets/(liabilities)
December 31, December 31,
2016
2015
$
6,714 $
635
1,043
190
448
11
21
392
9,454
5,335
394
1,043
110
478
(1)
13
297
7,669
(9,454)
(7,669)
$
- $
-
The net deferred tax asset as of the years ended December 31, 2016 and 2015 remains fully offset by a valuation due to the Company’s
history of losses.
The income tax benefit for the year ended December 31, 2016 differed from the amounts computed by applying the U.S. federal income tax
rate of 34% to loss before tax benefit as a result of nondeductible expenses, tax credits generated, utilization of net operating loss
carryforwards, and increases in the Company’s valuation allowance.
(In thousand $)
Federal statutory tax benefit
Permanent differences
State taxes
Valuation allowance
Income tax provision (benefit)
December 31, December 31,
2016
2015
$
$
(1,568) $
103
1
1,464
- $
(1,726)
306
1
1,421
2
A valuation allowance is required to reduce the deferred tax assets reported if, based on the weight of the evidence, it is more likely than
not that some portion or all of the deferred tax assets will not be realized.
At December 31, 2016, the Company had approximately $19.7 million of gross federal net operating loss carry-forwards. At December 31,
2016, the Company had approximately $10.6 million of gross state net operating loss carry-forwards. If not utilized, the federal and state
net operating loss carry-forwards will begin to expire in 2027. The utilization of such net operating loss carry-forwards and realization of
tax benefits in future years depends predominantly upon having taxable income. The Company also has $190 of federal research and
development credits which will begin to expire in 2033 if not utilized.
The Company may be subject to the net operating loss provisions of Section 382 of the Internal Revenue Code. The Company has not
calculated if an ownership change has occurred. The effect of an ownership change would be the imposition of an annual limitation on the
use of NOL carryforwards attributable to periods before the change. The amount of the annual limitation depends upon the value of the
Company immediately before the change, changes to the Company’s capital during a specified period, and the federal published interest
rate.
Entities are also required to evaluate, measure, recognize and disclose any uncertain income tax provisions taken on their income tax
returns. The Company has analyzed its tax positions and has concluded that as of December 31, 2015 there were no uncertain positions.
The federal and state income tax returns of the Company for 2012, 2013, 2014 and 2015 are subject to examination by the IRS and state
taxing authorities, generally for three years after they are filed. Interest and penalties, if any, as they relate to income taxes assessed, are
included in the income tax provision. There was no income tax related interest and penalties included in the income tax provision for 2016
and 2015.
F-25
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2016
(amounts in thousands, except share and per share amounts, unless otherwise indicated)
NOTE 12 – COMMITMENTS AND CONTINGENCIES
Operating Lease
The Company leases its corporate offices under an operating lease. The term of the lease is five years commencing on January 1, 2015 and
expiring on December 31, 2019. We have two options to renew our lease for an additional three years each.
At December 31, 2016, the future minimum lease payments under the non-cancellable operating lease in excess of one year is as follows:
(In thousand $)
Years Ended December 31,
2017
2018
2019
Total
Amount
69
71
72
212
$
$
Rent expense including common area maintenance charges and taxes for the years ended December 31, 2016 and 2015 was $72 and $225,
respectively.
Defined Contribution Plan
The Company established a 401(K) Plan (the “401(K) Plan”) for eligible employees of the Company effective April 1, 2014. Generally, all
employees of the Company who are at least twenty-one years of age and who have completed three months of service are eligible to
participate in the 401(K) Plan. The 401(K) Plan is a defined contribution plan that provides that participants may make salary deferral
contributions, of up to the statutory maximum allowed by law (subject to catch-up contributions) in the form of voluntary payroll
deductions. The Company’s matching contribution is equal to 100 percent on the first four percent of a participant’s compensation which is
deferred as an elective deferral. The Company’s aggregate matching contributions were $26 and $49 for the years ended December 31,
2016 and 2015, respectively.
Supply Agreement
On November 18, 2016, the Company entered into an Amended Supply Agreement with DIL Technologie GmbH (“ DIL ”). Pursuant to
the agreement (and so long as the agreement is effective), DIL will manufacture and supply the Company with Fortetropin®, the active
ingredient for its products, and the Company will purchase quantities of Fortetropin® from DIL in its discretion. DIL will manufacture the
formula exclusively for the Company in perpetuity, and may not manufacture the formula for other entities (but may manufacture it for its
own non-commercial research). The Company agreed, commencing January 2017, to pay DIL €10,000 per month for collaborative
research. The monthly payments terminate upon the earlier of: (a) the date that the Company orders additional product in accordance with
the terms of the agreement and (b) December 31, 2018, and the Company has no further financial obligations to DIL thereafter. The
Company also agreed to pay DIL €400,000 in satisfaction of all prior liabilities and obligations under its prior agreements with DIL. The
agreement expires on December 31, 2018, and the Company has the unilateral right to renew the agreement for subsequent one-year terms.
Product Liability
As a manufacturer of nutritional supplements that are ingested by consumers, the Company may be subject to various product liability
claims. Although we have not had any claims to date, it is possible that future product liability claims could have a material adverse effect
on our business or financial condition, results of operations or cash flows. The Company currently maintains products liability insurance of
$5 million per-occurrence and a $10 million annual aggregate coverage. At December 31, 2016 and 2015, the Company had not recorded
any accruals for product liability claims.
F-26
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2016
(amounts in thousands, except share and per share amounts, unless otherwise indicated)
NOTE 13 – RELATED PARTY TRANSACTIONS
The following is a description of the transactions we have engaged in with our directors, director nominees and officers and beneficial
owners of more than five percent of our voting securities and their affiliates:
On August 1, 2015, we entered into a consulting agreement with Muscle Longevity LLC, a company that has the same owner as Ultra Pro
Sports, LLC, a then greater than 5% beneficial owner of our common stock. Under the terms of the agreement, Muscle Longevity LLC
then agreed to provide introductions and referrals to new distribution channels for our products including, but not limited to, health and
wellness centers and sports nutrition companies and to conduct industry research and advise us regarding distributors, markets, and sales
opportunities for the Company’s products. As compensation for the services, Muscle Longevity LLC was paid a consulting fee of $16 per
month. The agreement was terminated in October 2016.
On December 17, 2015, concurrent with the execution of the Purchase Agreement with RENS Technology Inc., the Company issued an
unsecured promissory note in the principal amount of $575 (the “Note”) to Gan Ren, a related party of RENS Agriculture. The Note
accrued interest at a rate of 8% per annum and matured (the “Maturity Date”) on December 17, 2016. On the Maturity Date, the Note and
accrued interest of $46 were automatically converted into 225,864 shares of Common Stock at $2.75 per share.
On December 17, 2015, we entered into the Purchase Agreement with Rens Technology Inc. (the “Purchaser”), an entity which is
controlled by Ren Ren, who is currently a director of the Company and its largest stockholder. For additional information refer to Note 1 –
Strategic Investment Transaction. The Board agreed to issue Mr. Ren 18,182 shares of the Company’s common stock upon completion of
the first tranche of the Financing for his services to the Company as a member of the Board. (See Note 14 - Legal Proceedings)
NOTE 14 – LEGAL PROCEEDINGS
On January 6, 2017, the Company commenced an action in the Supreme Court of New York, County of New York, against RENS
Technology, Inc. ("the Purchaser"), RENS Agriculture, the parent company of the Purchaser, and Ren Ren, a principal in both entities and a
director of the Company, arising from the Purchaser's breach of a Securities Purchase Agreement under which the Purchaser agreed to
invest an aggregate of $20.25 million in the Company in exchange for an aggregate of 3,537,037 shares of common stock of the Company
and warrants to purchase an aggregate of 884,259 shares of common stock. In addition to seeking compensatory, consequential and other
damages in the action, the Company asked the Court to preliminarily restrain the Purchaser and its agents and representatives, including,
but not limited to, RENS Agriculture and Ren Ren, from selling, transferring, conveying, assigning, hypothecating or encumbering
1,500,000 shares of common stock of the Company and a warrant permitting the purchase of 375,000 share at a price of $7.00 per share
that the Purchaser had purchased under the Securities Purchase Agreement and, after the parties had an opportunity to submit opposition
and reply papers in connection with the Company's application, a preliminary injunction prohibiting the Purchaser from selling,
transferring, conveying, assigning, hypothecating or encumbering the 1,500,000 shares and warrant during the pendency of the action and
an order attaching the stock and warrant to satisfy any judgment entered in favor of the Company.
On January 11, 2017, the Court granted the Company the preliminary restraints that it requested, which prevents RENS Technology,
among others, from selling, transferring, conveying, assigning, hypothecating or encumbering the 1,500,000 shares of the Company’s
common stock or the aforementioned warrant. The Court scheduled a hearing on February 14, 2017, at which time the Court heard oral
argument on the application for a preliminary injunction and prejudgment attachment of the stock and warrants to satisfy any judgment
entered in favor of the Company. Since then, RENS Technology filed a motion to dismiss the complaint which the Company has opposed.
No decision has been made by the Court on these two pending applications.
On October 27, 2016, Cutler Holdings, L.L.C. (“Cutler”) filed a complaint in the Superior Court of New Jersey alleging that the Company
failed to make certain rental payments. On March 30, 2017, the Company entered into a settlement agreement with Cutler, pursuant to
which Cutler released the Company from any liability for the claims asserted in the complaint.
F-27
MYOS RENS TECHNOLOGY INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2016
(amounts in thousands, except share and per share amounts, unless otherwise indicated)
NOTE 15 – SUBSEQUENT EVENTS
Legal Proceedings
On January 6, 2017, the Company commenced an action in the Supreme Court of New York, County of New York, against RENS
Technology, Inc. (See Note 14)
Registered Direct Offering
On February 3, 2017, the Company entered into a securities purchase agreement with an institutional investor providing for the issuance
and sale by the Company of 500,000 shares of common stock, in a registered direct offering at a purchase price of $4.25 per share, for
gross proceeds of $2.125 million. The offering closed on February 8, 2017.
Preferred Stock Purchase Rights
Effective February 14, 2017, the Board of Directors declared a dividend of one right for each of the Company’s issued and outstanding
shares of common stock, $0.001 par value per share. The dividend will be paid to the stockholders of record at the close of business on
February 24, 2017. Each Right entitles the registered holder, subject to the terms of the Rights Agreement to purchase from the Company
one one-thousandth of a share of the Company’s Series A Preferred Stock at a price of $7.00), subject to certain adjustments. The
description and terms of the Rights are set forth in the Rights Agreement dated as of February 14, 2017 between the Company and Island
Stock Transfer, as Rights Agent.
At-the-Market Offering
On February 21, 2017, the Company entered into a sales Agreement with H.C. Wainwright & Co., LLC which establishes an at-the-market
equity program pursuant to which the Company may offer and sell up to $6.0 million of its shares of common stock from time to time
through H.C. Wainwright. As of the filing date of this Form 10-K, no shares have been sold under this program.
Settlement of Lawsuit
On March 30, 2017, the Company entered into a settlement agreement with Cutler, pursuant to which Cutler released the Company from
any liability for the claims asserted in the complaint. (See Note 14)
F-28
CONFIDENTIAL TREATMENT REQUESTED
WITH RESPECT TO CERTAIN PORTIONS HEREOF
DENOTED WITH “***”
Exhibit 10.3
AMENDED SUPPLY AGREEMENT
his Amended Supply Agreement ("Agreement") is hereby made effective on this _17_ day of November, 2016 ("Effective Date"), by and
between Myos Rens Technology Inc., a Nevada corporation, having an address of 45 Horsehill Road, Cedar Knolls, NJ 07927 (hereinafter
"Customer") and DIL Technologie GmbH, a German company having a business address of Prof.-von-Klitzing-Str . 7, D - 49610
Quakenbrtick, Germany (hereinafter "Manufacturer"), and is intended to supersede and replace the First Amended and Restated Exclusive
Supply Agreement entered into on July 15, 2014, which amended and replaced the Exclusive Supply Agreement entered into between the
Parties on June 24, 2013.
WHEREAS, the Parties agree as follows:
1. WORK
Manufacturer agrees to use its best efforts to perform the work (hereinafter "Work") pursuant to continuous and regular supply terms
discussed and agreed upon between the Parties, as initially determined herein. The Parties agree Work shall mean the manufacturing,
packaging and exportation of fertilized chicken egg yolk, via a patented process and form as defined in Exhibit A (the "Product").
2. REQUIREMENTS FOR PURCHASING
Commencing in January 2017, Customer shall pay Manufacturer €10,000 per month until Customer resumes ordering Product from
Manufacturer. The €10,000 per month payment shall cease upon the Customer issuance to the Manufacturer of a written purchase order or
December 31, 2018, whichever occurs first. . Customer and Manufacturer agree to establish a research program that Manufacturer shall
conduct on behalf of Customer's research needs, in exchange for these monthly payments.
Customer will provide to Manufacturer [
least of [***] kg per month for a minimum period of [***] months.
*
*
*
]
months advance notice for future purchase orders of the Products. Any order must be for at
The Parties agree that Manufacturer shall only manufacture, the Product for Customer or for Customer's commercial benefit, subject to the
terms and conditions specified in Section 5.1.2. This grant of exclusivity by Manufacturer to Customer is granted in perpetuity. Nothing
herein shall preclude Manufacturer from using Product for non-commercial purposes to further its own research advancements.
3. SHIPMENTS
All Products delivered pursuant to the terms of this Agreement shall be suitably packed for shipment in accordance with industry standards
in sealed containers/bags, marked for shipment to Customer's requested destination, and delivered to a carrier or forwarding agent, as
determined by Customer. Shipment will be F.O.B at Manufacturer, or Manufacturer's designated facility, and all freight, insurance, and
other shipping expenses, as well as any special packing expenses not included in the original price quotation for the Products will be paid
by Customer.
1
CONFIDENTIAL TREATMENT REQUESTED
WITH RESPECT TO CERTAIN PORTIONS HEREOF
DENOTED WITH “***”
4. cGMP COMPLIANCE, CERTIFICATE OF ANALYSIS AND WARRANTIES
4.1 cGMP Compliance
Manufacturer agrees that all Products made hereunder shall be manufactured in accordance with cGMP Compliance standards. In
particular, Manufacturer agrees to comply with cGMP batch record keeping standard as set forth by German Good Manufacturing Practice
standards for foodstuffs. The Parties agree the resulting Product or Blended Product shall also be in specific compliance with the standards
set forth in Exhibits C and D, respectively.
4.2 Certificate of Analysis
Manufacturer agrees to perform the necessary testing and analysis for each batch of Product or Blended Product manufactured and provide
Customer with a Certificate of Analysis therewith. Such Certificate of Analysis for each batch shall include test results for various
parameters listed in Exhibits C and D. Such Certificate of Analysis shall be signed and certified by a qualified employee of Manufacturer.
4.3 Certificate of Veterinarian
Manufacturer agrees to obtain the necessary certifications from a licensed German veterinarian for each batch of Product manufactured for
purposes of exporting the Product from the European Union. Customer shall notify Manufacturer of the requisite certification standards
pertaining to the importation of egg-based products from the European Union into the United States.
4.4 Express Warranty
(a) Manufacturer warrants that the Product will conform to all applicable product specifications as set forth herein and will be free
from contamination, i.e., under the threshold limits established in Exhibit C and Exhibit D.
(b) Upon any failure of a Product to comply with any and all applicable warranties, the Manufacturer shall promptly replace such
quantity of Product at no additional cost, within thirty (60) days of written notification of such failure.
5. PAYMENT TERMS, PRODUCT PRICING & CASH UPON SIGNING
5.1 PAYMENT TERMS
5.1.1 Human Application
2
CONFIDENTIAL TREATMENT REQUESTED
WITH RESPECT TO CERTAIN PORTIONS HEREOF
DENOTED WITH “***”
Customer agrees to pay Manufacturer €400,000 in exchange for the satisfaction of all prior terms duties, liabilities and obligations as set
forth in the First Amended and Restated Exclusive Supply Agreement dated July 15, 2014, including, but not limited to, all of the terms,
duties, liabilities and obligations set forth in Sections 6.2, 6.2.1 and 6.2.2 of that Agreement. The Parties hereby agree and acknowledge that
all prior terms duties, liabilities and obligations of both Parties as set forth in the First Amended and Restated Exclusive Supply Agreement
dated July 15, 2014 have been fully satisfied.
Payment shall be made as follows: Customer agrees to pay Manufacturer €400,000 within ten (10) days of the execution of this Agreement;
for acquiring the exclusive rights outside the United States for Manufacturer to exclusively manufacture, develop and produce Products for
Customer for human application.
5.1.2 Domesticated Animals Pet Application
Customer agrees to pay Manufacturer €[***] for a one (1)-year option commencing on January 1, 2017 for Customer to develop a strategic
plan for Products for domesticated animals pet sector outside the United States. By exercising this option, Customer has the right to pay an
additional €[***], within [***] year, to Manufacturer to acquire the exclusive rights outside the United States for Manufacturer to
exclusively manufacture, develop and produce Product for Customer in the domesticated animals pet sector. During this [***] year period,
Manufacturer shall not enter into any negotiation or agreement with a third party relating to the use of Product in the domesticated animal
pet sector. Domesticated animals shall hereby be defined to be household pets such as cats and dogs.
5.2 PRODUCT PRICING
Commencing on the Effective Date, the Parties agree the price per kilogram of Product shall be [***] Euros ([***]€). Manufacturer shall
use its best efforts to reduce such price through cost savings with its vendors, which it shall pass through to Customer.
6. INTELLECTUAL PROPERTY RIGHTS
Manufacturer is the owner of European Patent No. 12171561 (the "EP Patent"), which covers substantially similar subject matter as the
U.S. Application, and as of the Effective Date, is valid in several European jurisdictions . The Parties agree, in the event a third party
expresses bona fide interest in EU Patent for human application only (i.e., either to license or acquire the EU Patent) and Manufacturer
agrees in principal to the same, at any time during the validity of the EU Patent, Manufacturer shall notify Customer of the same in writing,
and shall offer Customer a right of first refusal to any potential transaction involving the EU Patent for human application only. Customer
shall have one hundred twenty (120) days from the receipt of the written notice to review, analyze, and consider accepting its right of first
refusal to such terms for the EU Patent. Manufacturer agrees any assignment or licensing of rights to the EU Patent to any third party for
human application only, without following the right of first refusal terms herein, shall render such assignment or license null and void.
3
CONFIDENTIAL TREATMENT REQUESTED
WITH RESPECT TO CERTAIN PORTIONS HEREOF
DENOTED WITH “***”
If Manufacturer files patent applications or procure patent rights covering substantially similar subject matter as the EP Patent or the U.S.
Application in other jurisdictions, the Parties agree that, Customer shall be offered the same right of first refusal to any potential
transaction involving a third party's expression of a bona fide interest in the worldwide patent rights for human application.
7. TERM AND TERMINATION
7.1 Term
The term of this Agreement shall commence on the Effective Date, and shall continue through December 31, 2018. Upon request from
Customer, this Agreement may be renewed for subsequent one year terms indefinitely unless terminated by Customer upon giving sixty
(60) days written notice prior to the expiration of any renewal term.
7.2 Termination
This Agreement may only be terminated by either party for cause upon written notice to the other party of a material breach hereof, or upon
written agreement of the Parties. Upon receipt of such notification, the breaching party shall be permitted Sixty (60) days to cure any such
breach. If after such sixty (60) days period the breaching party has not cured such breach, then the non breaching party may terminate this
Agreement immediately upon sending written notification of the same to the breaching party. Termination of this Agreement shall not
affect the obligations of either Party that exist as of the date of termination.
8. LIMITATIONS OF LIABILITY
8.1 Patents, Copyrights, Trade Secrets, Other Proprietary Rights
Each Party ("Indemnifying Party") shall defend, indemnify, and hold harmless the other Party ("Indemnified Party") from all claims, costs,
damages, judgments, and attorney's fees resulting from or arising out of any alleged and/or actual infringement or other violation of
intellectual property rights in connection with the performance by the Indemnifying Party of its obligations under this Agreement
("Intellectual Property Rights"). The Indemnified Party shall promptly notify the Indemnifying Party in writing of the initiation of any such
claims. In the event of any litigation, suit or other proceedings relating to or concerning such Intellectual Property Rights, the Indemnified
Party shall permit the Indemnifying Party to assume the defense thereof, and cooperate with the Indemnifying Party with respect to such
defense. If the Indemnifying Party elects not to assume the defense, the Indemnified Party shall have the right to seek, and have the
Indemnifying Party pay for separate counsel representing the interests of Indemnified Party. Further, any and all settlements regarding such
Intellectual Property Rights shall be approved in writing by an authorized representative of Indemnified Party.
4
CONFIDENTIAL TREATMENT REQUESTED
WITH RESPECT TO CERTAIN PORTIONS HEREOF
DENOTED WITH “***”
THE FOREGOING STATES THE ENTIRE LIABILITY OF THE PARTIES TO EACH OTHER CONCERNING INFRINGEMENT OF
INTELLECTUAL PROPERTY RIGHTS.
8.2 No Other Liability
INDEPENDENT OF OR UNDER THE EXPRESS WARRANTIES CREATED UNDER THIS AGREEMENT, IN NO EVENT SHALL
EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, OR
PUNITIVE DAMAGES OF ANY KIND OR NATURE ARISING OUT OF THIS AGREEMENT OR THE SALE OF PRODUCTS,
WHETHER SUCH LIABILITY IS ASSERTED ON THE BASIS OF CONTRACT, TORT (INCLUDING THE POSSIBILITY OF
NEGLIGENCE, INTENTIONAL MISCONDUCT OR STRICT LIABILITY), OR OTHERWISE, EVEN I F THE ONE PARTY HAS
BEEN WARNED OF THE POSSIBILITY OF ANY SUCH LOSS OR DAMAGE, AND EVEN IF ANY OF THE LIMITED REMEDIES
IN THIS AGREEMENT FAIL OF THEIR ESSENTIAL PURPOSE, IT BEING ACKNOWLEDGED BY THE PARTIES THAT THIS
LIMITATION OF LIABILITY IS ESSENTIAL CONSIDERATION FOR ENTERING INTO AND PERFORMANCE OF THIS
AGREEMENT.
8.3 Customer Responsible for U.S. Liability
Notwithstanding any of the above paragraphs, and for the avoidance of doubt, with the exception of willful or intentional acts or gross
misconduct of Manufacturer, Customer shall be responsible for any liability occurring within the United States, arising from
Manufacturer's manufacture of Products in accordance with the terms of this Agreement.
9. MISCELLANEOUS
9.1 Entire Agreement
This Agreement constitutes the entire agreement between the parties with respect to the transactions contemplated hereby and supersedes
all prior agreements and understandings between the parties relating to such transactions, unless such prior agreements are expressly
identified herein as remaining in full force and effect. Each Party shall hold the existence and terms of this Agreement confidential, unless
it obtains the other Party's express written consent otherwise, provided that Manufacturer may use Customer's name as a reference unless
otherwise instructed in writing by Customer.
9.2 Amendments
This Agreement may be amended only by a writing executed by authorized representatives of both parties.
5
9.3 Independent Contractor
Neither party shall, for any purpose, be deemed to be an agent of the other party; the relationship between the parties only be that of
independent contractors. Neither party shall have any right or authority to assume or create any obligations or to make any representations
or warranties on behalf of any other party, whether express or implied, or to bind the other party in any respect whatsoever.
9.4 Expenses
In the event a dispute between the parties hereunder with respect to this Agreement must be resolved by litigation or other proceeding or a
party must engage an attorney to enforce its right hereunder, the prevailing party shall be entitled to receive reimbursement for all
associated reasonable costs and expenses (including, without limitation, attorney's fees) from the other party.
9.5 Governing Law
This Agreement shall be governed by and construed under the laws of the United States.
9.6 Assignment
(a) Neither party shall assign or transfer this Agreement, except as expressly provided herein, without the prior written
consent of the other party; provided, however, that a Party may transfer or assign its rights and obligations under this Agreement in
connection with a merger, reorganization, consolidation or sale of all or substantially all of its assets.
(b) This Agreement shall be binding upon and inure to the benefit of the parties ' successors and assigns as permitted herein.
9.7 Customer's Confidential Information
The Parties agree the Mutual Non-Disclosure Agreement executed between them prior to the date hereof, shall be incorporated herein as if
written in full herein.
6
CONFIDENTIAL TREATMENT REQUESTED
WITH RESPECT TO CERTAIN PORTIONS HEREOF
DENOTED WITH “***”
9.8 Notice
Any notice or other communication required or permitted hereunder shall, unless otherwise provided herein, be made in writing and shall
be delivered personally or sent by an overnight delivery or courier service, by certified or registered mail (postage prepaid), by telegraph,
by telex, by facsimile transmission, or by email to the address first specified in this Agreement or to such other address as either party may
designate. A second notice shall be sent to Customer's legal counsel, Peter A. Levy, Esq., at Mandelbaum Salsburg PC, 3 Becker Farm
Road, Suite 105, Roseland NJ 07039, USA at PLevy@lawfirm.ms. Such notice or other communication shall be deemed given when so
delivered personally, telegraphed, telexed or sent by facsimile transmission, or, if sent by overnight delivery or courier service, the day after
sent, or if mailed, (3) days after the date of deposit in the mails.
9.9 Other
If any term or provision of the Agreement is declared to be invalid or unenforceable, it shall be deemed to be omitted or modified to the
extent necessary to render it valid or enforceable, and the remainder of this Agreement shall continue in full force and effect. Failure of
either party to enforce any provision hereof shall not be construed as a waiver thereof or prevent enforcement on any other occasion or of
any other provisions. Headings are for reference only; and the use of the singular and plural number shall each be deemed to include the
other as indicated by the context. All provisions in this Agreement which by their language, nature or context are intended to survive, such
as without limitation, payment limitation of liability and indemnification provisions, shall survive any termination of this Agreement.
9.10 Force Majeure
In the event that either party is prevented from performing or is unable to perform any of its obligations under this Agreement (other than a
payment obligation) due to any Act of God, fire, casualty, flood, earthquake, war, strike, lockout, epidemic, destruction of production
facilities, riot, insurrection, material unavailability, electricity or other utility or telecommunication outage or suspension of services, or any
other cause beyond the reasonable control of the party (or its selected vendors, affiliates, or the like) invoking this section, and if such party
shall have used its best efforts to mitigate its effects, such party shall give prompt written notice to the other party, its performance shall be
excused, and the time for the performance shall be extended for the period of delay or inability to perform due to such occurrences.
Regardless of the excuse of Force Majeure, if such party b not able to perform within forty-five (45) days after such event, the other party
may terminate this Agreement.
ACCEPTED AND AGREED TO:
FOR MYOS RENS TECHNOLOGIES INC.
DIL
By: /s/ Joseph Mannello
Printed Name: Joseph Mannello
Title: CEO
Date 11/17/16
By: /s/ Dr. Volker Heinz
Printed Name: Dr. Volker Heinz
Title: Vorstand
Date 18 Nov. 2016
7
CONFIDENTIAL TREATMENT REQUESTED
WITH RESPECT TO CERTAIN PORTIONS HEREOF
DENOTED WITH “***”
For purposes of this Agreement, the Product shall be comprised of 100% egg yolk powder, originating with fertilized chicken eggs. [***]
EXHIBIT A
DESCRIPTION OF THE PRODUCT
8
CONFIDENTIAL TREATMENT REQUESTED
WITH RESPECT TO CERTAIN PORTIONS HEREOF
DENOTED WITH “***”
EXHIBIT C
PRODUCT TESTING & ACCEPTABLE LIMITS
Parameter
Protein
Fat
Cholesterol
Moisture
Ash
Arsenic
Cadmium
Lead
Mercury
Total Viable Count
Total Coliforms
Enterobacteriaceae
E. Coli
L. Monocytogenes
Mesophile sulfide reducing Clostridium spp.
Salmonella spp.
Yeasts
Moulds
Staphlyococcus (coagulase positive)
9
Threshold
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
Exhibit 10.6
August 30, 2016
Joseph Mannello
137 Jockey Hollow Road
Bernardsville, New Jersey 07924
Re: Offer of Employment as Interim Chief Executive Officer
Dear Joe:
On behalf of MYOS RENS Technology Inc. (the “Company”), I am pleased to extend to you this offer of employment (“Offer Letter”) as
the Company’s interim Chief Executive Officer. We are excited to have you as a part of the senior management team and your expertise is
highly needed here. You will devote a minimum of forty (40) per week to the Company and report directly to the board of directors of the
Company (the “Board”).
You will receive an initial annual base salary of $240,000, payable in accordance with the Company’s policies. You will also be provided
with 10,000 shares of the Company’s common stock, which shall vest on the earlier of (i) the six month anniversary of your start date and
(ii) the date that the Company hires a permanent Chief Executive Officer. In addition, you will be eligible to receive additional equity
grants in conjunction with any financing transactions that the Company may consummate, at the sole discretion of the Board. You will be
eligible to receive an annual cash bonus in an amount up to 100% of your then current base salary (pro rated for any partial term), as may
be determined by the Board (or its compensation committee), in its sole discretion. Annual adjustments to salary, as well as bonus and
additional stock option awards are at the sole discretion of the Board (or its compensation committee). You will continue to be entitled to
receive compensation in your capacity as an existing member of the Board.
You are entitled to participate in the Company’s incentive plans or programs, including an ESOP, in each case as determined by the Board
(or its compensation committee), and you shall receive the opportunity to participate fully in the Company’s health insurance plan and any
other benefits provided to all employees of the Company. You shall be entitled to 20 vacation days and five sick days per calendar year
(prorated for the remainder of 2016).
Your employment with the Company deems you as an employee “at will.” This means that it is not for any specified period of time and
either you or the Company can terminate your employment at any time, and for any or no particular cause or reason.
This Offer Letter constitutes the sole and entire agreement of the parties to this agreement with respect to the subject matter contained
herein, and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral,
with respect to such subject matter.
This Offer Letter may only be amended, modified, or supplemented by an agreement in writing signed by each party hereto, and any of the
terms thereof may be waived, only by a written document signed by each party to this Offer Letter or, in the case of waiver, by the party or
parties waiving compliance.
This Offer Letter and your employment will be governed in all respects by laws of the State of New Jersey.
* * * *
We are excited about the future of MYOS and your contribution to our success. I look forward to receiving your acceptance of this
employment offer. To formally accept this offer, please sign in the appropriate place below and return an executed copy of this Offer Letter
to me. Please retain an executed copy of this Offer Letter for your own records.
Sincerely,
/s/ Christopher Pechock
Christopher Pechock
Chairman of the Compensation Committee
Acknowledged and agreed as of the date set forth below:
/s/ Joseph Mannello
Name: Joseph Mannello
Dated: 9/1/16
Amendment No. 3 to the
2012 Equity Incentive Plan
Exhibit 10.14
WHEREAS, MYOS RENS Technology Inc. (the “ Company”) has established the 2012 Equity Incentive Plan, effective
September 24, 2012 (the “Plan”);
WHEREAS, the Company's Board of Directors (the “Board”) has the authority pursuant to Section 14(a) of the Plan to amend the
Plan subject to the approval of holders of the Company's common stock (“Common Stock”), $0.001 par value per share (the
“Stockholders”) entitled to vote in accordance with applicable law;
WHEREAS, the Board desires to amend the Plan to increase the aggregate number of shares of the Company's Common Stock
that may be issued under the Plan (“Amendment No. 3”); and
WHEREAS, on November 17, 2016, the Board approved Amendment No. 3 and recommend its approval to the Stockholders;
NOW, THEREFORE, pursuant to the power of amendment set forth in the Plan and subject to the approval of Stockholders, the
Plan is hereby amended as follows effective upon the approval by the Stockholders of Amendment No. 3:
1. The reference to “550,000 shares” in the first sentence of paragraph (b) of Section 5 of the Plan is replaced in its
entirety with “850,000 shares”.
2. A new Section 5(f) of the Plan is hereby added to read in its entirety as follows:
“Notwithstanding any provision in the Plan to the contrary (but subject to adjustment as provided in Section 12), the
Committee shall not grant to any one Eligible Person in any one calendar year Awards (i) for more than 1,200,000 Common Shares in the
aggregate or (ii) payable in cash in an amount, when added to any cash fees paid by the Company as compensation to such Eligible Person,
exceeding $2,200,000 in the aggregate.”
3. A new Section 5(g) of the Plan is hereby added to read in its entirety as follows:
“Notwithstanding any provision in the Plan to the contrary (but subject to adjustment as provided in Section 12), the
aggregate value of all compensation paid or granted, as applicable, to any individual for service as a non-employee director (as defined in
Rule 16b-3(b)(3) of the Exchange Act) with respect to any calendar year, including Awards granted and any cash fees paid by the Company
as compensation to such non-employee director, shall not exceed $750,000 in total value. For purposes of this Section 5(g), the value of the
Awards shall be based on the grant date Fair Market Value of such Awards for financial reporting purposes.”
4. Section 11(c) of the Plan is replaced in its entirety with the following:
The Performance Criteria that will be used to establish the Performance Goal(s) shall be based on the attainment of specific
levels of performance of the Company and/or one or more Affiliates, divisions or operational units, or any combination of the foregoing, as
determined by the Committee, which criteria may be based on one or more of the following business criteria: (i) revenue; (ii) sales; (iii)
profit (net profit, gross profit, operating profit, economic profit, profit margins or other corporate profit measures); (iv) earnings (EBIT,
EBITDA, earnings per share, or other corporate earnings measures); (v) net income (before or after taxes, operating income or other
income measures); (vi) cash (cash flow, cash generation or other cash measures); (vii) stock price or performance; (viii) total stockholder
return (stock price appreciation plus reinvested dividends divided by beginning share price); (ix) economic value added; (x) return
measures (including, but not limited to, return on assets, capital, equity, investments or sales, and cash flow return on assets, capital, equity,
or sales); (xi) market share; (xii) improvements in capital structure; (xiii) expenses (expense management, expense ratio, expense efficiency
ratios or other expense measures); (xiv) business expansion or consolidation (acquisitions and divestitures); (xv) internal rate of return or
increase in net present value; (xvi) working capital targets relating to inventory and/or accounts receivable; (xvii) inventory management;
(xviii) service or product delivery or quality; (xix) customer satisfaction; (xx) employee retention; (xxi) safety standards; (xxii)
productivity measures; (xxiii) cost reduction measures; and/or (xxiv) strategic plan development and implementation. Any one or more of
the Performance Criteria adopted by the Committee may be used on an absolute or relative basis to measure the performance of the
Company and/or one or more Affiliates as a whole or any business unit(s) of the Company and/or one or more Affiliates or any
combination thereof, as the Committee may deem appropriate, or any of the above Performance Criteria may be compared to the
performance of a selected group of comparison companies, or a published or special index that the Committee, in its sole discretion, deems
appropriate, or as compared to various stock market indices. The Committee also has the authority to provide for accelerated vesting of any
Award based on the achievement of Performance Goals pursuant to the Performance Criteria specified in this paragraph. To the extent
required under Section 162(m) of the Code, the Committee shall, within the first 90 calendar days of a Performance Period (or, if longer or
shorter, within the maximum period allowed under Section 162(m) of the Code), define in an objective fashion the manner of calculating
the Performance Criteria it selects to use for such Performance Period and thereafter promptly communicate such Performance Criteria to
the Participant.
5. Except as hereinabove amended and modified, the Plan shall remain in full force and effect.
6. A majority in voting interest of the stockholders present in person or by proxy and entitled to vote at the meeting
of stockholders at which this Amendment No. 3 to the Plan was considered, has duly approved this Amendment No. 3 to the Plan.
IN WITNESS WHEREOF, this Amendment No. 3 to the Plan is made effective this 21st day of December, 2016.
MYOS RENS TECHNOLOGY INC.
By:
/s/ Joseph Mannello
Name: Joseph Mannello
Title: Chief Executive Officer
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in the Registration Statement of MYOS RENS Technology Inc. and Subsidiary (formerly
known as MYOS Corporation) on Form S-3 (No. 333-199392) of our report dated March 30, 2016, on our audit of the consolidated
financial statements as of December 31, 2015 and for the year then ended , which report is included in this Annual Report on Form 10-K to
be filed on or about March 30, 2017.
Exhibit 23.1
/s/ EisnerAmper LLP
Iselin, New Jersey
March 30, 2017
CONSENT OF REGISTERED INDEPENDENT PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in the Registration Statement of MYOS RENS Technology Inc. and Subsidiary on Form S3
(No.333-199392) of our report dated March 29, 2017, on our audit of the consolidated financial statements as of December 31, 2016 and
for the year then ended, which report is included in this Annual Report on Form 10-K to be filed on March 29, 2017.
Exhibit 23.2
/s/ WithumSmith+Brown, PC
New Brunswick, New Jersey
March 30, 2017
Exhibit 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO SECURITIES EXCHANGE ACT RULES 13A-14(A) AND 15D-14(A)
AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Joseph Mannello, certify that:
1. I have reviewed this annual report on Form 10-K of MYOS RENS Technology Inc. (the “report”);
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to
make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period
covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed
under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such
evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the
registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is
reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent
functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which
are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the
registrant’s internal control over financial reporting.
Dated: March 30, 2017
/s/ Joseph Mannello
By:
Name: Joseph Mannello
Title: Chief Executive Officer
(Principal Executive Officer, Principal
Financial officer and Principal Accounting
Officer)
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.1
In connection with this annual report on Form 10-K of MYOS RENS Technology Inc. (the “Company”) for the year ended December 31,
2016, (the “Report”), I, Joseph Mannello, the Principal Executive Officer of the Company, do hereby certify, pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge:
1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 as amended; and
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of
the Company.
Dated: March 30, 2017
/s/ Joseph Mannello
By:
Name: Joseph Mannello
Title: Chief Executive Officer
(Principal Executive Officer, Principal
Financial Officer and Principal Accounting
Officer)
This certification accompanies this annual report on Form 10-K pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not,
except to the extent required by such Act, be deemed filed by the Company for purpose of Section 18 of the Securities Exchange Act of
1934, as amended.