CEDAR KNOLLS, N.J.,
March 28, 2019 /PRNewswire/ -- MYOS
RENS Technology Inc. ("MYOS" or "the Company") (NASDAQ: MYOS), an
advanced nutrition company and the owner of
Fortetropin®, a proprietary bioactive composition
derived from fertilized egg yolk that helps build lean muscle,
announced today its results for the fourth quarter and fiscal year
ended December 31, 2018.
MANAGEMENT COMMENTARY:
Joseph
Mannello, Chief Executive Officer of MYOS,
commented, "Our overall performance in fiscal year 2018
reflected much of the transformation of our business that I
referred to in my letter to shareholders in January 2019.
"I discussed our near-term initiatives for positioning our
Fortetropin-based product brands to grow our sales. We reached
several key milestones on this front in 2018, including the launch
of our NSF "Certified for Sport®" sports nutrition
brand, Yolked®, along with our pet product MYOS Canine
Muscle Formula® ("MYOS Canine"). In less than a
year's time, we have expanded our sales opportunities for both
brands, and we expect to deliver increased sales in 2019 for these
products.
"For our Yolked brand, we've expanded our marketing
partnership with IMG in order to introduce Yolked to colleges
throughout the country. In addition, our sales partnership with The
Vitamin Shoppe® began in earnest in early
2019 to get our Yolked brand on the shelves of their 700+ stores
throughout the country. With our revamped website (www.yolked.com)
and our in-house sales and marketing initiatives, I'm excited about
the potential of Yolked.
"We launched MYOS Canine in June
2018. Since then, we announced our first distribution
agreement which will bring greater exposure to veterinary
hospitals. The feedback and testimonials we've received from our
initial customers on our website www.myospet.com, have been
overwhelmingly positive. Together with the encouraging results from
our Kansas State University study,
which validates our product benefits to veterinarians, I'm very
optimistic about the commercial opportunities for our pet business
product line in 2019.
"Our long-term initiatives are rooted in our ability to research
the clinical uses of Fortetropin to fully leverage its potential
and determine our entry-point into the medical nutrition market. We
believe these studies and research initiatives will support our
ability to build and enhance our patent portfolio and to improve
our current product offering with the development of new products.
We currently have one clinical and one pre-clinical study underway
and anticipate launching additional clinical studies over the next
several months. With the compelling results from our Kansas State University study, we feel confident to
move forward with a human clinical study related to muscle atrophy
after total knee replacement surgery.
"We recently launched our second Kansas
State University study, which expands the scope of potential
patients from our earlier study to include geriatric dogs
experiencing weakness, weight loss, slow mobility, and exercise
intolerance. The results of this study will help us to expand our
business in the animal health market.
"I expect 2019 will be an important and eventful year for MYOS.
We continually evaluate ways to increase our cash runway by
controlling expenses and generating cash from increased sales,
potential licensing and/or financing transactions. I see a
tremendous opportunity for MYOS to capitalize on our attractively
positioned brands to create more widespread adoption of our
products. We will work diligently to refine our strategic approach
to capitalize on opportunities in front of us today, while paving a
path towards sustainable profitability over the long term,"
concluded Mr. Mannello.
CLINICAL RESEARCH HIGHLIGHTS:
- On February 27, 2019, MYOS
announced the launch of a new research study with Kansas
State University College of Veterinary
Medicine to evaluate the impact of Fortetropin on quality of
life and activity in geriatric dogs. The study will be performed
under the supervision of Kenneth R.
Harkin, DVM, DACVIM (SAIM), Professor and Section Head,
Small Animal Internal Medicine. Forty (40) geriatric dogs that
suffer from three of the following conditions will be recruited to
participate in the study: weakness, weight loss, slowed or altered
mobility, or exercise intolerance. Twenty (20) of these dogs will
be assigned to receive Fortetropin and 20 will be assigned to
receive a macronutrient-matched placebo. All of the dogs
participating in the study will be fitted with an activity collar.
After two weeks of initial activity monitoring, the dogs will
receive either Fortetropin or placebo for 12 weeks. The Quality of
Life (QOL) assessment will be based on the Liverpool Osteoarthritis
in Dogs (LOAD) Questionnaire.
- On January 15, 2019 MYOS
announced positive top-line results from a randomized,
double-blind, placebo-controlled study by Kansas State University evaluating the impact of
Fortetropin on attenuating muscle atrophy following a common
surgical procedure known as tibial-plateau leveling osteotomy
("TPLO") in 100 dogs. Key findings of the study included:
-
- Fortetropin prevented the loss of muscle mass in these dogs as
measured by the thigh circumference in their affected and
unaffected limbs.
- Fortetropin-supplemented dogs had a more significant
improvement in percentage of weight supported by the affected limb
as determined by force plate stance analysis (more rapid return to
normal stance force distribution) than the placebo group.
- Fortetropin prevented a rise in serum myostatin levels
(myostatin is a protein that prevents muscle growth).
- Dr. Kenneth R. Harkin, DVM,
DACVIM (SAIM), Professor and Section Head, College of Veterinary
Medicine, Kansas State University, and
principal investigator of the study, presented an oral summary of
the study results at the North American Veterinary Community (NAVC)
/ VMX Conference on January 20, 2019
in Orlando, Florida. The
presentation was entitled, "The Impact of Fortetropin®
Supplementation on Dogs Recovering from Tibial-Plateau Leveling
Osteotomy (TPLO) Surgery."
BUSINESS & OPERATIONAL HIGHLIGHTS:
- On February 7, 2019 MYOS
announced an endorsement partnership with NBA superstar
Aaron Gordon of the Orlando Magic.
Gordon will serve as an endorser of Yolked, our "NSF Certified for
Sport" branded sports nutrition product. In addition:
-
- Yolked expanded its national college athletics marketing
campaign via partnerships with nine (9) additional universities.
Since the beginning of 2019, Yolked has had a prominent presence in
college basketball via TV-visible courtside LED signage seen on
nationally televised games, introducing the brand to millions of
fans across the country.
- Beyond the TV-visible signage, Yolked is featured on each
athletic department's official website and official social media
channels and is a staple at basketball home games as sponsor of
nightly on-court fan contests and t-shirt toss promotions.
- In the fall, Yolked will be prominently featured throughout the
college football season with in-stadium signage, on-site
experiential activities, digital assets, social media, and
more.
- On January 1, 2019, MYOS received
the United States Patent # 10,165,785 titled, "Process for
Producing Composition for Increasing Muscle Mass" from the United
States Patent and Trademark Office (USPTO). This new patent
significantly enhances MYOS' existing intellectual property
portfolio, enabling MYOS to protect its advanced technologies for
the development of innovative nutrition products to address
musculoskeletal health.
- On December 11, 2018, MYOS
announced that The Vitamin Shoppe will distribute 'Yolked'
formulated with Fortetropin, MYOS' muscle-enhancing sports
nutrition product line. The Vitamin Shoppe is the first retailer to
carry Yolked at its 775 store locations across the U.S. and online
at vitaminshoppe.com.
- On December 6, 2018, MYOS
received approval from the New Jersey Economic Development
Authority ("NJEDA") to receive approximately $1.1 million in non-dilutive funding for general
working capital purposes by transferring its tax benefits through
the NJEDA New Jersey Technology Business Tax Certificate Transfer
Program, which provides a mechanism for approved New Jersey technology and biotechnology
companies to sell their unused net operating loss carryovers and
research and development tax credits for cash.
- On November 8, 2018, MYOS
announced that it signed a distribution agreement with Miller
Veterinary Supply East ("Miller"), which will allow MYOS to sell
its MYOS Canine Muscle Formula to veterinary hospitals on the east
coast. MYOS Canine has been well received by all, including
holistic veterinarians, who were impressed with the
"single-ingredient" product.
- On October 2, 2018, MYOS
announced that MYOS Enteral Nutrition Formula™, formulated with
Fortetropin, became eligible for Medicare and Medicaid
reimbursement, as it was approved as an HCPCS B4150 Product after
review by the Pricing, Data Analysis, and Coding Contractor for the
Centers for Medicare and Medicaid Services. This HCPCS B4150 code
is used to describe enteral formulas which are nutritionally
complete with intact nutrients, including proteins, fats,
carbohydrates, vitamins, and minerals. Securing Medicare and
Medicaid reimbursement widens the spectrum of patients who could
gain access to this product, and we believe such reimbursement will
encourage clinicians to utilize this product in their
practices.
FINANCIAL HIGHLIGHTS (Amounts in thousands except
where noted.):
Fourth Quarter 2018:
Net sales for the quarter ended December
31, 2018 were $149, a decrease
of $8, or 5%, compared to
$157 for the quarter ended
December 31, 2017.
Cost of sales for the quarter ended December 31, 2018 increased 33% to $97, compared to cost of sales of $64 for the quarter ended December 31, 2017.
Gross profit for the quarter ended December 31, 2018 decreased 45% to $51, compared to $93 for the quarter ended December 31, 2017. Gross profit margin for the
quarter ended December 31, 2018 was
34%, compared to 59% for the quarter ended December 31, 2017.
Operating expenses were $1,224 in
the quarter ended December 31, 2018,
an increase of 5% compared to operating expenses of $1,173 for the quarter ended December 31, 2017.
Net loss decreased 96% to $62 for
the quarter ended December 31, 2018
compared to $1,082 for the quarter
ended December 31, 2017.
Year Ended December 31,
2018
Net sales for the year ended December 31, 2018 were $360, a decrease of $166, or 32%, compared to $526 for the year ended December 31, 2017 primarily due to net sales of
$327 in 2017 of our previous product
lines, offset by an increase in sales of $161 in all of our current product lines,
including Yolked® and MYOS Canine Muscle
Formula®.
Cost of sales for the year ended December
31, 2018 were $248, a decrease
of $60 or 19%, compared to cost of
sales of $308 for the year ended
December 31, 2017, primarily due to
lower costs associated with a decrease in direct sales to
consumers.
Gross profit for the year ended December
31, 2018 decreased 49% to $112, compared to $218 for the year ended December 31, 2017.
Operating expenses were $4,441 for
the year ended December 31, 2018, an
increase of 4% compared to operating expenses of $4,286 for the year ended December 31, 2018. This was due to a $72 increase in sales and marketing expenses,
primarily for marketing and promotional costs associated with the
development and launch of new products in 2018, a $267 increase in personnel and benefits costs,
primarily for the hiring of additional sales staff to support the
new product launch, and a $183
decrease in general and administrative expenses, due to a decrease
in costs associated with legal proceedings.
Net loss decreased $835 or 21% to
$3,223 for the year ended
December 31, 2018 compared to
$4,058 for the year ended
December 31, 2017.
Liquidity
As of December 31,
2018, the Company had cash of $15 and total assets of $4,455, and $1,269
in working capital. Net cash used in operating activities for the
year ended December 31, 2018 was
$3,250, a decrease of $533 compared to $3,783 for the year ended December 31, 2017.
At-the-Market Offering
Subsequent to year end, on
January 15, 2019, the Company sold
32,489 shares of common stock for $2.00 per share for gross proceeds of
$65, and on March 19, 2019, the Company sold 73,560 shares of
common stock for $1.86 per share for
gross proceeds of $138.
CONFERENCE CALL
MYOS will host a conference call on
Thursday, March 28, 2019 at
11:00 AM ET, at which time MYOS'
Chief Executive Officer Joseph
Mannello will provide commentary on earnings results and
provide an update on the business.
Conference Call Details:
- Dial In: 877-407-4019 from the U.S.; international
callers may telephone 201-689-8337, approximately 15 minutes before
the call
A digital replay will be available by telephone approximately
two hours after the completion of the call until June 30, 2019 and may be accessed by dialing
877-660-6853 from the U.S. or 201-612-7415 for international
callers, using the Conference ID# 13689169.
This call will be simultaneously webcast. The webcast will be
available on the MYOS website, www.myosrens.com, in the "Investor
Relations" section. The webcast will be archived and available at
the same web address for two weeks following the call.
About MYOS RENS Technology Inc.
MYOS RENS
Technology Inc. (MYOS), "The Muscle Company®", is a
Cedar Knolls, NJ-based advanced
nutrition company that develops and markets products that improve
muscle health and performance. MYOS is the owner of
Fortetropin®, a fertilized egg yolk-based product
manufactured via a proprietary process to retain and optimize its
biological activity. Fortetropin has been clinically shown to
increase muscle size and lean body mass in conjunction with
resistance training. MYOS believes Fortetropin has the potential to
redefine existing standards of physical health and wellness. For
more information, please visit www.MYOSRENS.com.
Forward-Looking Statements
Any statements in
this release that are not historical facts are forward-looking
statements. Actual results may differ materially from those
projected or implied in any forward-looking statements. Such
statements involve risks and uncertainties, including but not
limited to those relating to product and customer demand, market
acceptance of our products, the ability to create new products
through research and development, the successful results of
strategic initiatives, the success of our products,
including Qurr®,
Yolked®, MYOS Enteral
Nutrition Formula™ and MYOS Canine Muscle
Formula® products, the
success of our research and development, the results of the
clinical evaluation of Fortetropin® and
its effects including the clinical study described herein, the
ability to enter into new partnership opportunities and the success
of our existing partnerships, the ability to generate revenue and
cash flow from sales of our products, the ability to increase our
revenue and gross profit margins, the ability to achieve a
sustainable, profitable business, the effect of economic
conditions, the ability to protect our intellectual property
rights, competition from other providers and products, the
continued listing of our securities on the Nasdaq Stock Market,
risks in product development, our ability to raise capital to fund
continuing operations, and other factors discussed from time to
time in our filings with the Securities and Exchange
Commission. We undertake no obligation to update or revise any
forward-looking statement for events or circumstances after the
date on which such statement is made except as required by
law.
These statements have not been evaluated by the Food and Drug
Administration. Our products are not intended to diagnose, treat,
cure or prevent any disease.
The following tables should be read in conjunction with the
footnotes accompanying the consolidated financial statements
contained within the Annual Report on Form 10-K filed by the
Company on March 27, 2019.
MYOS RENS
TECHNOLOGY INC. AND SUBSIDIARY
Consolidated
Balance Sheets
(in thousands,
except share amounts)
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2018
|
|
|
2017
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
|
|
$
|
15
|
|
|
$
|
923
|
|
Accounts receivable,
net
|
|
|
78
|
|
|
|
4
|
|
Other current
asset
|
|
|
1,124
|
|
|
|
-
|
|
Inventories,
net
|
|
|
1,676
|
|
|
|
1,779
|
|
Prepaid
expenses
|
|
|
10
|
|
|
|
113
|
|
Total current
assets
|
|
|
2,903
|
|
|
|
2,819
|
|
|
|
|
|
|
|
|
|
|
Other
asset
|
|
|
50
|
|
|
|
50
|
|
Deferred offering
costs
|
|
|
108
|
|
|
|
102
|
|
Fixed assets,
net
|
|
|
149
|
|
|
|
184
|
|
Intangible assets,
net
|
|
|
1,245
|
|
|
|
1,640
|
|
Total
assets
|
|
$
|
4,455
|
|
|
$
|
4,795
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS'
EQUITY
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
236
|
|
|
$
|
176
|
|
Accrued expenses and
other current
liabilities
|
|
|
383
|
|
|
|
255
|
|
Related party
promissory note payable and
accrued interest
|
|
|
1,015
|
|
|
|
-
|
|
Total current
liabilities
|
|
|
1,634
|
|
|
|
431
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
|
1,634
|
|
|
|
431
|
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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, 2018 and 2017;
7,481,723
and 6,340,604 shares issued
and
outstanding at
December 31, 2018 and
2017, respectively
|
|
|
8
|
|
|
|
6
|
|
Additional paid-in
capital
|
|
|
37,880
|
|
|
|
36,202
|
|
Accumulated
deficit
|
|
|
(35,067)
|
|
|
|
(31,844)
|
|
Total stockholders'
equity
|
|
|
2,821
|
|
|
|
4,364
|
|
Total liabilities and
stockholders' equity
|
|
$
|
4,455
|
|
|
$
|
4,795
|
|
MYOS RENS
TECHNOLOGY INC. AND SUBSIDIARY
Consolidated
Statements of Operations
(in thousands,
except per share amounts)
|
|
|
|
Years
Ended
|
|
|
|
December
31,
|
|
|
|
2018
|
|
|
2017
|
|
|
|
|
|
|
|
|
Net
revenues
|
|
$
|
360
|
|
|
$
|
526
|
|
Cost of
sales
|
|
|
248
|
|
|
|
308
|
|
Gross
profit
|
|
|
112
|
|
|
|
218
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Selling, marketing
and research
|
|
|
894
|
|
|
|
822
|
|
Personnel and
benefits
|
|
|
1,718
|
|
|
|
1,450
|
|
General and
administrative
|
|
|
1,829
|
|
|
|
2,014
|
|
Total operating
expenses
|
|
|
4,441
|
|
|
|
4,286
|
|
Operating
loss
|
|
|
(4,329)
|
|
|
|
(4,068)
|
|
Other (expense)
income:
|
|
|
|
|
|
|
|
|
Other (expense)
income
|
|
|
(2)
|
|
|
|
12
|
|
Interest
expense
|
|
|
(16)
|
|
|
|
(2)
|
|
Total other (expense)
income
|
|
|
(18)
|
|
|
|
10
|
|
Loss before income
taxes
|
|
|
(4,347)
|
|
|
|
(4,058)
|
|
|
|
|
|
|
|
|
|
|
Income tax
benefit
|
|
|
1,124
|
|
|
|
-
|
|
Net loss
|
|
$
|
(3,223)
|
|
|
$
|
(4,058)
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common
shareholders:
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
$
|
(0.45)
|
|
|
$
|
(0.69)
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares
outstanding:
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
7,139,312
|
|
|
|
5,875,239
|
|
MYOS RENS
TECHNOLOGY INC. AND SUBSIDIARY
Consolidated
Statements of Cash Flows
(in
thousands)
|
|
|
|
Years
Ended
|
|
|
|
December
31,
|
|
|
|
2018
|
|
|
2017
|
|
Cash Flows From
Operating Activities:
|
|
|
|
|
|
|
Net loss
|
|
$
|
(3,223)
|
|
|
$
|
(4,058)
|
|
Adjustments to
reconcile net loss to net cash used in
operating activities:
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
35
|
|
|
|
51
|
|
Amortization
|
|
|
395
|
|
|
|
267
|
|
Provision for
inventory reserve
|
|
|
25
|
|
|
|
2
|
|
Bad debt
expense
|
|
|
-
|
|
|
|
59
|
|
Share-based
compensation
|
|
|
235
|
|
|
|
160
|
|
Deferred offering
costs
|
|
|
97
|
|
|
|
-
|
|
Changes in operating
assets and liabilities:
|
|
|
|
|
|
|
|
|
Increase in accounts
receivable
|
|
|
(74)
|
|
|
|
(55)
|
|
Increase in other
current asset
|
|
|
(1,124)
|
|
|
|
-
|
|
Decrease in
inventories
|
|
|
78
|
|
|
|
81
|
|
Decrease (increase)
in prepaid expenses
|
|
|
103
|
|
|
|
(78)
|
|
Decrease in deferred
revenue
|
|
|
-
|
|
|
|
(56)
|
|
Decrease in accounts
payable and accrued expenses
|
|
|
203
|
|
|
|
(156)
|
|
Net cash used in
operating activities
|
|
|
(3,250)
|
|
|
|
(3,783)
|
|
|
|
|
|
|
|
|
|
|
Cash Flows From
Investing Activities:
|
|
|
|
|
|
|
|
|
Purchases of fixed
assets
|
|
|
-
|
|
|
|
(2)
|
|
Net cash used in
investing activities
|
|
|
-
|
|
|
|
(2)
|
|
|
|
|
|
|
|
|
|
|
Cash Flows From
Financing Activities:
|
|
|
|
|
|
|
|
|
Proceeds from
registered direct offering of common stock,
net of costs
|
|
|
1,450
|
|
|
|
2,944
|
|
Deferred offering
costs from at-the-market transaction
|
|
|
(108)
|
|
|
|
(102)
|
|
Proceeds from related
party promissory note payable
|
|
|
1,000
|
|
|
|
-
|
|
Net cash provided by
financing activities
|
|
|
2,342
|
|
|
|
2,842
|
|
|
|
|
|
|
|
|
|
|
Net decrease in
cash
|
|
|
(908)
|
|
|
|
(943)
|
|
Cash at beginning of
year
|
|
|
923
|
|
|
|
1,866
|
|
Cash at end of
year
|
|
$
|
15
|
|
|
$
|
923
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
Cash paid during the
year for:
|
|
|
|
|
|
|
|
|
Interest
|
|
$
|
1
|
|
|
$
|
2
|
|
|
|
|
|
|
|
|
|
|
Supplemental
schedule of non-cash investing and
financing activities:
|
|
|
|
|
|
|
|
|
Recognition
of deferred offering costs as a reduction of
equity
in connection with the at-the-market offering
|
|
$
|
6
|
|
|
$
|
23
|
|
Investor Relations:
Porter LeVay & Rose
Michael Porter, President
Phone: 212-564-4700
Email: MYOS@plrinvest.com
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SOURCE MYOS RENS Technology