Nevada
|
|
0-30379
|
|
88-0425691
|
(State or other jurisdiction
|
|
(Commission File Number)
|
|
(IRS Employer
|
of Incorporation)
|
|
|
|
Identification Number)
|
|
|
3661 Horseblock Road
|
|
|
|
|
Medford, NY 11763
|
|
|
|
|
(Address of principal executive offices)
|
|
|
|
|
631-924-1135
|
|
|
|
|
(Registrant's Telephone Number)
|
|
|
99.1
|
Press Release entitled "Chembio Diagnostics Reports Third Quarter 2014 Financial Results" dated November 6, 2014
|
99.2
|
Presentation entitled "Investor Presentation November 2014" dated November 6, 2014.
|
99.3
|
Investor Fact Sheet posted to the company website dated November 6, 2014.
|
Exhibit Number
|
Description
|
99.1
|
Press Release entitled "Chembio Diagnostics Reports Third Quarter 2014 Financial Results" dated November 6, 2014
|
99.2
|
Presentation entitled "Investor Presentation November 2014" dated November 6, 2014.
|
99.3
|
Investor Fact Sheet posted to the company website dated November 6, 2014.
|
•
|
Total revenues of $7.31 million compared with $9.62 million (a decrease of 24.0%);
|
•
|
DPP® revenues of $5.41 million compared with $1.88 million (an increase of 188%);
|
•
|
Operating loss of $262,000, compared with operating income of $1,074,000;
|
•
|
Net loss of $271,000, or $0.03 per diluted share, compared with net income of $717,000, or $0.07 per diluted share.
|
•
|
Total revenues of $20.55 million compared with $21.69 million (a decrease of 5.3%);
|
•
|
DPP® revenues of $11.75 million compared with $3.72 million (an increase of 216%)
|
•
|
Operating loss of $878,000, compared with operating income of $1,181,000;
|
•
|
Net loss of $641,000, or $0.07 per diluted share, compared with net income of $793,000, or $0.08 per diluted share.
|
Chembio Diagnostics, Inc. & Subsidiary
|
||||||||||||||||||||
Summary of Consoldidated Results of Operations
|
||||||||||||||||||||
(UNAUDITED)
|
||||||||||||||||||||
|
||||||||||||||||||||
|
For the three months ended
|
For the nine months ended
|
||||||||||||||||||
|
September 30, 2014
|
September 30, 2013
|
September 30, 2014
|
September 30, 2013
|
||||||||||||||||
Net product sales
|
$
|
7,247,881
|
$
|
9,044,714
|
$
|
19,400,515
|
$
|
20,419,595
|
||||||||||||
|
||||||||||||||||||||
License and royalty revenue
|
8,482
|
898
|
15,613
|
898
|
||||||||||||||||
|
||||||||||||||||||||
R&D, milestone and grant revenue
|
57,946
|
572,027
|
1,133,850
|
1,268,821
|
||||||||||||||||
|
||||||||||||||||||||
TOTAL REVENUES
|
$
|
7,314,309
|
$
|
9,617,639
|
$
|
20,549,978
|
$
|
21,689,314
|
||||||||||||
|
||||||||||||||||||||
GROSS MARGIN
|
$
|
2,650,390
|
$
|
4,056,186
|
$
|
7,905,551
|
$
|
9,031,251
|
||||||||||||
|
||||||||||||||||||||
Research and development expenses
|
$
|
972,439
|
$
|
1,602,297
|
$
|
3,438,714
|
$
|
4,148,201
|
||||||||||||
|
||||||||||||||||||||
Selling, general and administrative expenses
|
$
|
1,940,424
|
$
|
1,379,845
|
$
|
5,344,914
|
$
|
3,702,181
|
||||||||||||
|
||||||||||||||||||||
(LOSS) INCOME FROM OPERATIONS
|
$
|
(262,473
|
)
|
$
|
1,074,044
|
$
|
(878,077
|
)
|
$
|
1,180,869
|
||||||||||
|
||||||||||||||||||||
OTHER (EXPENSE) INCOME
|
$
|
1,136
|
$
|
1,477
|
$
|
(1,180
|
)
|
$
|
10,877
|
|||||||||||
|
||||||||||||||||||||
Income tax (benefit) provision
|
$
|
9,284
|
|
$
|
358,850
|
$
|
(237,916
|
)
|
|
$
|
398,940
|
|||||||||
|
||||||||||||||||||||
NET (LOSS) INCOME
|
$
|
(270,621
|
)
|
|
$
|
716,671
|
$
|
(641,341
|
)
|
|
$
|
792,806
|
||||||||
|
||||||||||||||||||||
Basic (loss) earnings per share
|
$
|
(0.03
|
)
|
|
$
|
0.08
|
$
|
(0.07
|
)
|
|
$
|
0.09
|
||||||||
|
||||||||||||||||||||
Diluted earnings (loss) per share
|
$
|
(0.03
|
)
|
|
$
|
0.07
|
$
|
(0.07
|
)
|
$
|
0.08
|
|||||||||
|
||||||||||||||||||||
Weighted average number of shares outstanding, basic
|
9,611,139
|
|
9,324,783
|
9,503,084
|
8,886,998
|
|||||||||||||||
|
||||||||||||||||||||
Weighted average number of shares outstanding, diluted
|
9,611,139
|
|
9,824,019
|
9,503,084
|
|
9,433,152
|
Chembio Diagnostics, Inc. & Subsidiary
|
||||||||
Summary of Consolidated Balance Sheets
|
||||||||
|
||||||||
|
||||||||
|
September 30, 2014
|
December 31, 2013
|
||||||
|
(UNAUDITED)
|
|||||||
CURRENT ASSETS:
|
||||||||
Cash and cash equivalents
|
$
|
3,672,702
|
$
|
9,650,275
|
||||
Accounts receivable, net of allowance for doubtful accounts of $24,000 at September 30, 2014 and December 31, 2013, respectively
|
8,315,651
|
4,592,121
|
||||||
Inventories
|
3,975,250
|
3,188,726
|
||||||
Prepaid expenses and other current assets
|
1,035,435
|
1,099,379
|
||||||
TOTAL CURRENT ASSETS
|
16,999,038
|
18,530,501
|
||||||
|
||||||||
FIXED ASSETS, net of accumulated depreciation
|
2,118,756
|
1,978,232
|
||||||
|
||||||||
OTHER ASSETS
|
4,810,825
|
3,977,859
|
||||||
|
||||||||
TOTAL ASSETS
|
$
|
23,928,619
|
$
|
24,486,592
|
||||
|
||||||||
|
||||||||
CURRENT LIABILITIES:
|
||||||||
Accounts payable and accrued liabilities
|
$
|
3,819,271
|
$
|
4,309,490
|
||||
|
||||||||
TOTAL LIABILITIES
|
3,819,271
|
4,309,490
|
||||||
|
||||||||
STOCKHOLDERS' EQUITY:
|
||||||||
Common stock - $.01 par value; 100,000,000 shares authorized; 9,611,139 and 9,324,783 shares issued and outstanding for September 30, 2014 and December 31, 2013, respectively
|
96,112
|
93,248
|
||||||
Additional paid-in capital
|
47,445,750
|
46,875,027
|
||||||
Accumulated deficit
|
(27,432,514
|
)
|
(26,791,173
|
)
|
||||
TOTAL STOCKHOLDERS' EQUITY
|
20,109,348
|
20,177,102
|
||||||
|
||||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
23,928,619
|
$
|
24,486,592
|
||||
|
Chembio Diagnostics, Inc. & Subsidiary
|
||||||||||||
Summary of Consolidated Cash Flow
|
||||||||||||
For the nine months ended
|
||||||||||||
(UNAUDITED)
|
||||||||||||
|
September 30, 2014
|
September 30, 2013
|
||||||||||
|
||||||||||||
Net cash (used in) provided by operating activities
|
$
|
(5,154,604
|
)
|
$
|
583,808
|
|||||||
Net cash used in investing activities
|
(1,060,149
|
)
|
|
(796,274
|
)
|
|||||||
Net cash provided by financing activities
|
237,180
|
5,306,412
|
||||||||||
(DECREASE)/INCREASE IN CASH AND CASH EQUIVALENTS
|
$
|
(5,977,573
|
)
|
$
|
5,093,946
|
•
|
Global Provider of High Quality POC Infectious Disease Tests
|
‐
|
Sales in 43 countries
|
•
|
Consistent Track Record of Revenue Growth
|
‐
|
Global Revenue of $29.6MM (FY 2013); CAGR 21.7% (2009 to 2013)
|
•
|
Patented DPP® (Dual Path Platform®) Technology
|
‐
|
Lead Product: DPP® Blood/Oral Fluid HIV Test – FDA Approved & CLIA-Waived
|
•
|
Future Pipeline of DPP® POC Assays
|
‐
|
HIV-Syphilis Combination Test
|
‐
|
HIV Antibody Assays
|
‐
|
HCV Test
|
‐
|
POC DPP® Assays for Ebola, Dengue Fever, Febrile Illness and Type of Cancer
|
•
|
Revenue (FY '13): $9.7MM or 35%
|
•
|
Established U.S. Sales & Marketing (June '14)
|
•
|
DPP® HIV 1/2 FDA Approved, CLIA-Waived
|
•
|
Funded Research: CDC, DOD, NIH (2013)
|
•
|
Achieved CE mark for SURECHECK® HIV (July '13)
|
•
|
Achieved CE mark for HIV STATPAK®, (March '14)
|
•
|
Pending CE mark for DPP® HIV and DPP® HIV/Syphilis Assays
|
•
|
Established License, Technical Transfer, Contract Manufacturing, Distribution Agreement (Feb. '14)
|
•
|
Revenue (FY '13): $13.2MM or 48%
|
•
|
Strong OEM Partnerships (e.g., FIOCRUZ, Labtest)
|
•
|
Branded products sold to NGOs, private distributors
|
•
|
Revenue (FY '13): $4.4MM or 16%
|
•
|
Sales channel: NGO-direct & through distributors
|
•
|
Procurements primarily funded by PEPFAR, Global Fund, and WHO
|
|
2011 Sales
|
2016 Sales
|
CAGR
|
Glucose
|
1,530
|
1,640
|
1%
|
Infectious Disease
|
810
|
950
|
3%
|
Critical Care
|
725
|
875
|
4%
|
Cardiac Markers
|
500
|
650
|
5%
|
Hematology
|
430
|
500
|
3%
|
Coagulation/PT, ACT
|
400
|
450
|
2%
|
Fecal Occult Blood
|
295
|
450
|
9%
|
Cholesterol/Lipids
|
275
|
355
|
5%
|
Drugs of Abuse
|
265
|
270
|
0%
|
HbA1c
|
150
|
300
|
15%
|
Other*
|
150
|
190
|
n/a
|
Pregnancy
|
130
|
135
|
1%
|
•
|
35.2 million people living with HIV/AIDS worldwide (2012)
|
•
|
1.6 million people died of AIDS-related illnesses (2012)
|
•
|
In total, ~75 million people have been infected with the HIV virus and ~36 million have died of HIV
|
•
|
Approx. 12 million people globally become ill with syphilis annually
|
•
|
From 2005-2013, syphilis cases in the U.S. nearly doubled, from 8,724 to 16,663
|
•
|
Syphilis in pregnancy leads to ~305,000 fetal & neonatal deaths annually
|
•
|
More than 1.1 million people in the United States are living with HIV infection, and almost 1 in 6 (15.8%) are unaware of their infection
|
•
|
There are ~50,000 new infections per year in the U.S.
|
•
|
For every HIV infection that is prevented, an estimated $355,000 is saved in the cost of providing lifetime HIV treatment
|
•
|
Two Lateral Flow POC HIV Tests (U.S.)
|
‐
|
Chembio HIV 1/2 STAT-PAK®
|
‐
|
Chembio SURE CHECK® HIV 1/2 ¹
|
•
|
Key Product Features
|
‐
|
FDA (PMA)-Approved, CLIA-Waived
|
‐
|
Sensitivity: 99%
|
‐
|
CE Marked, WHO Approved
|
•
|
Chembio Global Revenue $20.2MM FY 2013
|
‐
|
United States: $8.9MM (14% growth vs. FY '12)
|
‐
|
International: $11.8MM (85% growth vs. FY '12)
|
•
|
Lateral flow patent expires in 2015
|
‐
|
Chembio's royalty payments for lateral flow technology end Feb 2015
|
·
|
Patented technology
|
·
|
Allows improved sensitivity compared to lateral flow technology
|
·
|
Enables multiple test results via a single blood sample (e.g., HIV-Syphilis Combo Assay)
|
·
|
Offers application within infectious disease and potential for a number of other indications
|
•
|
U.S. FDA (PMA) approved, CLIA-Waived for use with Blood and Oral Fluid samples
|
•
|
U.S. Launch- Q4 2014
|
•
|
Entering the ~$35MM Oral Fluid Assay market
|
•
|
Superior Performance (Sensitivity) vs. competitors
|
•
|
Patented SampleTainer®Sample Collection System
|
•
|
First to enter market with POC HIV-Syphilis combination assay
|
•
|
First HIV-Syphilis Assay to be USAID Approved
|
•
|
Successfully launched in Latin America (Mexico)
|
•
|
Global screening opportunities:
|
‐
|
Pregnant Women (Incidence 1.9MM)1
|
‐
|
MSM (up to 70% HIV-Syphilis co-infection)2
|
·
|
DPP® HIV-Syphilis Assay (U.S. market)
|
o
|
Next Generation DPP® HIV-Syphilis "Combo" Assay for detection of HIV and Syphilis Antibodies
|
·
|
DPP® HCV Assay
|
o
|
Assay for the detection of Hepatitis C Antibody
|
·
|
DPP® HIV Ab/Ag Assay
|
o
|
Next Generation DPP HIV for the detection of HIV Antibody and Antigen
|
·
|
DPP® HIV 1/2 Oral Fluid Assay Enhancements
|
o
|
Next Generation DPP® HIV Assay for the enhanced detection of antibodies in oral fluid
|
•
|
Oswaldo Cruz Foundation (Brazil)
|
‐
|
Five DPP® Products , 2013 revenues ~$6MM
|
•
|
LabTest (Brazil)
|
‐
|
Assembly, Distribution – DPP® Co-branded (2014 Product Registration)
|
•
|
RVR (Malaysia)
|
‐
|
License, Technical Transfer, Contract Manufacturing, Distribution
|
•
|
IBT (U.S.)
|
‐
|
Technology partnership to develop Ebola Assay
|
•
|
Other
|
‐
|
Undisclosed partners for DPP® Dengue Fever and specific type of Cancer
|
‐
|
Additional opportunities in discussion/development
|
•
|
Leased facilities (~60,000 sq. ft.) in Medford and Holbrook, NY
|
•
|
High Volume Manufacturing Capabilities (>15MM tests annually)
|
•
|
Robust Quality Management System
|
‐
|
POC tests serve diverse, regulated market
|
‐
|
Audited routinely by FDA CDRH/CBER, WHO, USDA, ISO (LNE), and our partners
|
‐
|
Expertise in Manufacturing scale up, process validation and cGMP
|
Nine Months Ended (in 000's)
|
September 30, 2014
|
September 30, 2013
|
||||||
NET PRODUCT REVENUES
|
$
|
19,401
|
$
|
20,420
|
||||
TOTAL REVENUES
|
$
|
20,550
|
$
|
21,689
|
||||
GROSS MARGIN
|
$
|
7,906
|
$
|
9,031
|
||||
INCOME FROM OPERATIONS
|
$
|
(878
|
)
|
$
|
1,181
|
|||
NET INCOME
|
$
|
(641
|
)
|
$
|
793
|
|||
CASH (as of end of period)
|
$
|
3,673
|
$
|
8,046
|
•
|
Product Development/Regulatory
|
‐
|
Achieved CE Mark for HIV 1/2 STAT-PAK®: March 2014
|
‐
|
Received CLIA-Waiver for DPP® HIV 1/2 CLIA: October 2014
|
‐
|
Obtained POC license for certain IBT Ebola reagents: October 2014
|
‐
|
Entered development agreements for Dengue Fever and Cancer assays: October 2014
|
‐
|
Finalized Agreement with RVR (Malaysia) to build position in Asia: Feb 2014
|
‐
|
Established U.S. Distribution/Warehouse facility in Holbrook, NY: May 2014
|
‐
|
Terminated STAT-PAK® Distribution Agreement with U.S. Distributor: June 2014
|
‐
|
Established Chembio U.S. Sales & Marketing team to focus on DPP® HIV 1/2 and HIV 1/2 STAT-PAK® Assays: June 2014
|
‐
|
Signed agreements with three leading U.S. distribution companies for sales of DPP® HIV 1/2 and HIV 1/2 STAT-PAK®: September-October 2014
|
•
|
Finalize additional DPP® license and/or development collaborations
|
•
|
Increase Manufacturing Footprint and Capacity in Medford, NY
|
•
|
Pursue Acquisitions or Licenses of Complementary Products/Technologies
|
•
|
Seek External Support to Accelerate Development of DPP® Ebola Assay
|
•
|
Commercial / Sales & Marketing
|
•
|
Expand ex-U.S. Revenues for Lateral Flow and DPP® Products
|
•
|
New Distribution, Contract Development & OEM Deals
|
•
|
International Sales Growth of DPP® HIV-Syphilis Test
|
•
|
Global Provider of High Quality POC Infectious Disease Tests
|
‐
|
Sales in 43 countries
|
•
|
Consistent Track Record of Revenue Growth
|
‐
|
Global Revenue of $29.6MM (FY 2013); CAGR 21.7% (2009 to 2013)
|
•
|
Patented DPP® (Dual Path Platform®) Technology
|
‐
|
Lead Product: DPP® Blood/Oral Fluid HIV Test – FDA-Approved & CLIA-Waived
|
•
|
Future Pipeline of DPP® POC Assays
|
‐
|
HIV-Syphilis Combination Test
|
‐
|
HIV Antibody Assays
|
‐
|
HCV Test
|
•
|
High Value Collaborations and Development Projects
|
‐
|
POC DPP® Assays for Ebola, Dengue Fever, Febrile Illness and Type of Cancer
|
V/W>A4)%Q@7=6)&B!88MP@N?]T\>;1Y\G_,D]\T9[]Y
MB(V_8T1G1IHE#3=->NE@XHL'6#JN>4*DI#V>[4*#Y7I2PVK';+5GU^Y[NE/,
M4'G',Y#64=H2$Q/%JL2_Q08L7DAVR8C8R)$C26\[7`S!Q>K5JVGM(WN5C"U;
MMM#/2C8I*X&7@P?8KILN@ZU
M,U*R#(\^F$A6&@][LBQ_0$KCP8#23\[P_GV8/ I_!J%]LM+AH"`+9!8\!@CUHE3G^XA91U;#\O/]P%7<=8>:
MO!.'#Q_YCX-S)KDQ 26-I'!'0L21^7!_"J@COM2#K#"R0QJ"RJ
MN`!_,FB(F,DNU,1!@8<<$-UQBDMX9=1N6WCY=GITK:72)(4ACCC\S())QP,=
MVSV/I3HK"XEOMJ!EA4#$H8`;3R01U[?K6BC<5S+_`+%O9-S;UV]RS=SCM5R;
MP_-W:W6YE7F%
MV((&,CY?ZF@!(VE>T+W(.%D+J2,$\?-^I%0RL;Z1(K2V82$Y8L>E6$CEU64P
M64;)&0!+(YR0.<