Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care
("POC") diagnostic tests for infectious diseases, today reported
financial results for the third quarter ended September 30, 2017.
John J. Sperzel, III, Chembio’s President and
CEO, stated, "During the third quarter of 2017, the Company
continued to make progress with each of its key objectives: 1)
strengthening the core sexually transmitted disease business, 2)
building a broad tropical and fever disease portfolio, and 3)
building a global commercial team.
"With respect to the Company’s sexually
transmitted disease business, Chembio increased total HIV product
sales during the third quarter of 2017 by 273% compared to the
prior year period, achieving HIV product sales growth in the United
States, Latin America, Europe and Africa. In the U.S., the Company
continues to prioritize development of its DPP® HIV-Syphilis
Assay in response to the global concerns related to HIV and
Syphilis co-infection and mother-to-child transmission.
We expect to complete the U.S. clinical trial for our DPP®
HIV-Syphilis Assay by year-end, in preparation for the FDA
submission, which we believe keeps us on track to be the first to
market a combination HIV-Syphilis Assay in the U.S. Outside
the U.S., Chembio experienced significant growth in its HIV
Self-Test business, resulting in 219% year-over-year growth through
the first three quarters.
“Turning to our tropical and fever disease
business, the Company advanced its DPP® Malaria and DPP® Dengue
Assays during the third quarter. It is important to note that these
two diseases account for approximately 600 million cases annually.
The field evaluation of our DPP® Malaria Assay, which previously
received funding from the Bill & Melinda Gates Foundation, was
completed during the third quarter, and we plan to begin
commercialization of this ultra-sensitive test during 2018. We
previously initiated sales of our DPP® Dengue Assay, including
CDC’s pilot program for our DPP® Dengue/Zika/Chikungunya Assay in
four countries: India, Peru, Haiti and Guatemala.
“We also reached important regulatory milestones
during the third quarter of 2017. In July, Chembio’s DPP® Zika
System, including the DPP® Micro Reader, was approved by Brazil’s
Health Regulatory Agency. In September, Chembio became the first
company to receive U.S. Food and Drug Administration (FDA)
Emergency Use Authorization (EUA) for a rapid Zika test. The
Company’s U.S. DPP® Zika project has been funded with Federal funds
from the Department of Health and Human Services; Office of the
Assistant Secretary for Preparedness and Response; Biomedical
Advanced Research and Development Authority, Contract No.
HHSO100201600022C.”
Addressing the Company's financial results, Mr.
Sperzel commented, "During the third quarter of 2017, Chembio
achieved total revenue of $7.6 million, which represents a 102%
increase over the prior-year period and the fourth highest quarter
in Company history. Product sales during the third quarter of 2017
were $6.1 million, which represents a 145% increase over the
prior-year period. During the first nine months of 2017, Chembio
achieved total revenue of $18.0 million, which represents a 32%
increase over the prior-year period. Product sales during the first
nine months of 2017 were $14.4 million, which represents a 38%
increase over the prior-year period. The sales growth achieved in
several target regions during the third quarter of 2017, compared
to the prior-year period, including a 386% increase in Latin
America, a 100% increase in Africa, a 32% increase in the United
States, and a 27% increase in Europe, further validates the
strength and effectiveness of our global sales organization.”
Summary Financial Information comparing
the 2017 three-month third quarter to the 2016 third
quarter:
- Total revenues of $7.6 million, compared with $3.7 million (an
increase of 102.5%).
- Product sales of $6.1 million, compared with $2.5 million (an
increase of 145.1%).
- Operating loss of $0.6 million, compared with operating loss of
$2.1 million.
- Net loss of $0.6 million, or $0.05 per diluted share, compared
with net loss of $2.1 million, or $0.19 per diluted
share.
Summary Financial Information comparing
the first nine months of 2017 to the first nine months of
2016:
- Total revenues of $18.0 million, compared with $13.6 million
(an increase of 32.4%).
- Product sales of $14.5 million, compared with $10.5 million (an
increase of 38.3%).
- Operating loss of $4.4 million, compared with operating loss of
$5.0 million.
- Net loss of $4.4 million, or $0.36 per diluted share, compared
with net loss of $10.8, or $1.06 per diluted share. The net
loss in the 2016 period includes a tax provision for the recording
of a valuation allowance on the Company's deferred tax asset of
$5.8 million.
Additional Financial
Information:
Third Quarter:
Total revenues in the 2017 third quarter of $7.6
million increased 102.5% compared with $3.7 million in the
prior-year period. Product sales in the 2017 third quarter of $6.1
million increased 145.1% compared with $2.5 million in the
prior-year period. R&D milestone, and grant and royalty
revenues in the 2017 third quarter of $1.5 million increased 16.9%
compared with $1.2 million in the prior-year period.
Gross margin dollars in the 2017 third quarter
of $3.5 million increased 80.5% compared with $2.0 million in the
prior-year period, due primarily to increased product sales.
Product gross margin dollars in the 2017 third quarter of $2.1
million increased 192.2% compared with $0.7 million in the
prior-year period, which also was primarily due to increased
product revenues.
R&D expenses in the 2017 third quarter of
$1.8 million decreased 20.2%, compared with $2.3 million in the
prior-year period. Selling, general and administrative
expenses in the 2017 third quarter of $2.3 million increased 25.8%
compared with $1.8 million in the prior-year period, largely due to
investments made to the scale-up of our sales and marketing
organization globally, and professional fees.
Operating loss in the 2017 third quarter was
$0.6 million, compared with an operating loss of $2.1 million in
the prior-year period.
Net loss in the 2017 third quarter was $0.6
million, or $0.05 per diluted share, compared with net loss of $2.1
million, or $0.19 per diluted share, in the prior-year
period.
First Nine Months:
Total revenues in the 2017 first nine months of
$18.0 million increased 32.4% compared with $13.6 million in the
prior-year period. Product sales in the 2017 first nine months of
$14.5 million increased 38.3% compared with $10.5 million in the
prior-year period. R&D milestone, and grant and royalty
revenues in the 2017 first nine months of $3.6 million increased
13.1% compared with $3.2 million in the prior-year period.
Gross margin dollars in the 2017 first nine
months of $8.5 million increased 27.5% compared with $6.7 million
in the prior-year period, due primarily to the increase in product
sales. The amount of product gross margin in the 2017 first nine
months of $5.0 million increased 40.4% compared with $3.5 million
in the prior-year period, which also was primarily due to increased
product revenues.
R&D expenses in the 2017 first nine months
of $6.0 million decreased 3.7%, compared with $6.3 million in the
prior-year period. Selling, general and administrative
expenses in the 2017 first nine months of $6.9 million increased
27.1%, compared with $5.4 million in the prior-year period, largely
due to investments made to scale up our sales and marketing
organization globally, and professional fees.
Operating loss in the 2017 first nine months was
$4.4 million, compared with an operating loss of $5.0 million in
the prior-year period.
Net loss in the 2017 first nine months was $4.4
million, or $0.36 per diluted share, compared with net loss of
$10.8 million, or $1.06 per diluted share, in the prior-year
period. The net loss in the 2016 period includes a tax
provision for the recording of a valuation allowance on the
Company's deferred tax asset of $5.8 million.
Balance Sheet Highlights:
The Company had cash and cash equivalents of
$1.9 million as of September 30, 2017, compared with $10.6 million
as of December 31, 2016. The decrease was primarily due to net cash
used in operating activities of $7.2 million. Our working capital
decreased by $4.9 million from $14.7 million as of December 31,
2016 to $9.8 million, largely due to cash used in operating
activities and in investing activities, primarily for the
acquisition in RVR Diagnostics Sdn Bhd, for the nine months of
2017. Subsequent to that acquisition, we have changed the
name of RVR Diagnostics Sdn Bhd to Chembio Diagnostics Malaysia Sdn
Bhd.
Conference Call
To participate on the conference call, please
dial (888) 567-1602 from the U.S. or (404) 267-0373 from outside
the U.S. To listen live via the Internet, please visit the
Investor Relations section of Chembio's website at
www.chembio.com.
To listen to a replay of the call, which will be
accessible until November 15, 2017 at 11:59 p.m. ET, please dial
(877) 481-4010 from the U.S. or (919) 882-2331 from outside the
U.S., and enter conference ID #:22282. An archive of the
webcast will be available for 90 days on the Company's website at
www.chembio.com.
About Chembio Diagnostics
Chembio Diagnostics, Inc. develops,
manufactures, licenses and markets proprietary rapid diagnostic
tests in the growing $8.0 billion point-of-care testing
market. Chembio markets each of its DPP® HIV 1/2 Assay,
HIV 1/2 STAT-PAK® Assay, and SURE CHECK® HIV 1/2 Assay,
with these Chembio brand names, in the U.S. and internationally,
and its STAT-VIEW® Assay in Europe, both directly and through
third-party distributors.
Chembio has developed a patented point-of-care
test platform technology, the Dual Path Platform (DPP®) technology,
which has significant advantages over lateral-flow technologies.
This technology is providing Chembio with a significant pipeline of
business opportunities for the development and manufacture of new
products.
Headquartered in Medford, NY, Chembio is
licensed by the U.S. Food and Drug Administration (FDA) as well as
the U.S. Department of Agriculture (USDA), and is certified for the
global market under the International Standards Organization (ISO)
directive 13485. Each of Chembio Diagnostic Systems, Inc. and
Chembio Diagnostics Malaysia Sdn Bhd (formerly known as RVR
Diagnostics Sdn Bhd) is a wholly-owned subsidiary of Chembio
Diagnostics, Inc. For more information, please
visit: www.chembio.com.
Forward-Looking Statements
Statements contained herein that are not
historical facts may be forward-looking statements within the
meaning of the Securities Act of 1933, as amended. Forward-looking
statements include statements regarding the intent, belief or
current expectations of the Company and its management. Such
statements, which are estimates only, reflect management's current
views, are based on certain assumptions, and involve risks and
uncertainties. Actual results, events, or performance may differ
materially from the above forward-looking statements due to a
number of important factors, and will be dependent upon a variety
of factors, including, but not limited to Chembio's ability to
obtain additional financing and to obtain regulatory approvals in a
timely manner, as well as the demand for Chembio's products.
Chembio undertakes no obligation to publicly update these
forward-looking statements to reflect events or circumstances that
occur after the date hereof or to reflect any change in Chembio's
expectations with regard to these forward-looking statements or the
occurrence of unanticipated events. Factors that may impact
Chembio's success are more fully disclosed in Chembio's most recent
public filings with the U.S. Securities and Exchange
Commission.
(Tables to follow)
Contacts:
Vida Strategic Partners (investor
relations)Stephanie C. Diaz(415) 675-7401sdiaz@vidasp.com
|
|
|
|
|
|
|
|
|
|
Chembio Diagnostics, Inc. &
Subsidiaries |
Summary of Consolidated Results of
Operations |
(UNAUDITED) |
|
|
|
|
|
|
|
|
|
|
|
|
For the three months
ended |
|
|
For the nine months
ended |
|
|
September 30, 2017 |
|
September 30, 2016 |
|
|
September 30, 2017 |
|
September 30, 2016 |
Net product
sales |
|
$ |
6,132,725 |
|
|
$ |
2,502,097 |
|
|
|
$ |
14,453,097 |
|
|
$ |
10,453,188 |
|
|
|
|
|
|
|
|
|
|
|
License and royalty
revenue |
|
|
150,000 |
|
|
|
77,754 |
|
|
|
|
477,631 |
|
|
|
133,850 |
|
|
|
|
|
|
|
|
|
|
|
R&D, milestone and grant
revenue |
|
|
1,304,649 |
|
|
|
1,166,610 |
|
|
|
|
3,096,626 |
|
|
|
3,026,927 |
|
|
|
|
|
|
|
|
|
|
|
TOTAL
REVENUES |
|
$ |
7,587,374 |
|
|
$ |
3,746,461 |
|
|
|
$ |
18,027,354 |
|
|
$ |
13,613,965 |
|
|
|
|
|
|
|
|
|
|
|
GROSS
MARGIN |
|
$ |
3,522,583 |
|
|
$ |
1,952,097 |
|
|
|
$ |
8,539,506 |
|
|
$ |
6,697,950 |
|
|
|
|
|
|
|
|
|
|
|
Research and development
expenses |
|
$ |
1,805,738 |
|
|
$ |
2,263,719 |
|
|
|
$ |
6,034,735 |
|
|
$ |
6,265,483 |
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative
expenses |
|
$ |
2,305,358 |
|
|
$ |
1,832,451 |
|
|
|
$ |
6,903,055 |
|
|
$ |
5,430,668 |
|
|
|
|
|
|
|
|
|
|
|
LOSS FROM
OPERATIONS |
|
$ |
(588,513 |
) |
|
$ |
(2,144,073 |
) |
|
|
$ |
(4,398,284 |
) |
|
$ |
(4,998,201 |
) |
|
|
|
|
|
|
|
|
|
|
OTHER
INCOME: |
|
$ |
3,852 |
|
|
$ |
5,855 |
|
|
|
$ |
24,956 |
|
|
$ |
9,729 |
|
|
|
|
|
|
|
|
|
|
|
Income tax
provision |
|
$ |
- |
|
|
$ |
- |
|
|
|
$ |
- |
|
|
$ |
5,800,818 |
|
|
|
|
|
|
|
|
|
|
|
NET
LOSS |
|
$ |
(584,661 |
) |
|
$ |
(2,138,218 |
) |
|
|
$ |
(4,373,328 |
) |
|
$ |
(10,789,290 |
) |
|
|
|
|
|
|
|
|
|
|
Basic loss per
share |
|
$ |
(0.05 |
) |
|
$ |
(0.19 |
) |
|
|
$ |
(0.36 |
) |
|
$ |
(1.06 |
) |
|
|
|
|
|
|
|
|
|
|
Diluted loss per
share |
|
$ |
(0.05 |
) |
|
$ |
(0.19 |
) |
|
|
$ |
(0.36 |
) |
|
$ |
(1.06 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares
outstanding, basic |
|
|
12,311,098 |
|
|
|
11,142,090 |
|
|
|
|
12,293,781 |
|
|
|
10,150,737 |
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares
outstanding, diluted |
|
|
12,311,098 |
|
|
|
11,142,090 |
|
|
|
|
12,293,781 |
|
|
|
10,150,737 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chembio Diagnostics, Inc. &
Subsidiaries |
Summary of Consolidated Balance
Sheets |
(UNAUDITED) |
|
|
|
|
|
|
|
September 30, 2017 |
|
December 31, 2016 |
|
|
|
|
|
CURRENT
ASSETS: |
|
|
|
|
Cash and cash
equivalents |
|
$ |
1,871,982 |
|
|
$ |
10,554,464 |
|
Accounts receivable,
net of allowance for doubtful accounts of $52,000 at September 30,
2017 and December 31, 2016, respectively |
|
|
5,768,920 |
|
|
|
3,383,729 |
|
Inventories, net |
|
|
5,235,164 |
|
|
|
3,335,188 |
|
Prepaid expenses and
other current assets |
|
|
842,532 |
|
|
|
840,145 |
|
TOTAL CURRENT
ASSETS |
|
|
13,718,598 |
|
|
|
18,113,526 |
|
|
|
|
|
|
FIXED ASSETS, net of accumulated
depreciation |
|
|
1,964,427 |
|
|
|
1,709,321 |
|
|
|
|
|
|
OTHER
ASSETS |
|
|
3,561,679 |
|
|
|
752,389 |
|
|
|
|
|
|
TOTAL ASSETS |
|
$ |
19,244,704 |
|
|
$ |
20,575,236 |
|
|
|
|
|
|
- LIABILITIES
AND STOCKHOLDERS’ EQUITY - |
|
|
|
|
|
|
|
|
|
TOTAL CURRENT
LIABILITIES |
|
$ |
3,870,161 |
|
|
$ |
3,405,650 |
|
|
|
|
|
|
TOTAL
LIABILITIES |
|
|
4,305,631 |
|
|
|
3,405,650 |
|
|
|
|
|
|
STOCKHOLDERS’
EQUITY: |
|
|
|
|
Common stock - $.01 par
value; 100,000,000 shares authorized; 12,318,570 and 12,026,847
shares issued and outstanding at September 30, 2017 and December
31, 2016, respectively |
|
|
123,185 |
|
|
|
120,268 |
|
Additional paid-in
capital |
|
|
62,733,065 |
|
|
|
60,721,783 |
|
Accumulated other
comprehensive income |
|
|
128,616 |
|
|
|
- |
|
Accumulated
deficit |
|
|
(48,045,793 |
) |
|
|
(43,672,465 |
) |
TOTAL
STOCKHOLDERS’ EQUITY |
|
|
14,939,073 |
|
|
|
17,169,586 |
|
|
|
|
|
|
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
$ |
19,244,704 |
|
|
$ |
20,575,236 |
|
|
|
|
|
|
|
|
|
|
|
Chembio Diagnostics, Inc. &
Subsidiaries |
Summary of Consolidated Cash
Flows |
For the nine months
ended |
(UNAUDITED) |
|
|
September 30, 2017 |
|
September 30, 2016 |
|
|
|
|
|
Net cash used
in operating activities |
|
$ |
(7,176,935 |
) |
|
$ |
(5,676,073 |
) |
Net cash used
in investing activities |
|
|
(1,639,827 |
) |
|
|
(79,877 |
) |
Net cash
provided by financing activities |
|
|
134,280 |
|
|
|
12,550,973 |
|
INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS |
|
$ |
(8,682,482 |
) |
|
$ |
6,795,023 |
|
|
|
|
|
|
Chembio Diagnostics (NASDAQ:CEMI)
Historical Stock Chart
From Feb 2024 to Mar 2024
Chembio Diagnostics (NASDAQ:CEMI)
Historical Stock Chart
From Mar 2023 to Mar 2024