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)
|
|
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
|
|
|
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
|
|
|
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
|
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
|
99.1
|
Press Release entitled “FIOCRUZ Receives Regulatory Approval to Market Chembio's Syphilis Treponemal Test” dated May 3, 2011.
|
99.2
|
Press Release entitled “Chembio Reports 1st Quarter 2011 Results” dated May 5, 2011.
|
99.3
|
Presentation entitled “Investor Presentation May 2011” dated May 5, 2011.
|
99.4
|
Investor Fact Sheet posted to the company website dated May 5, 2011.
|
Exhibit Number
|
Description
|
99.1
|
Press Release entitled “FIOCRUZ Receives Regulatory Approval to Market Chembio's Syphilis Treponemal Test” dated May 3, 2011.
|
99.2
|
Press Release entitled “Chembio Reports 1st Quarter 2011 Results” dated May 5, 2011.
|
99.3
|
Presentation entitled “Investor Presentation May 2011” dated May 5, 2011.
|
99.4
|
Investor Fact Sheet posted to the company website dated May 5, 2011.
|
·
|
Product sales for the quarter ended March 31, 2011 (first quarter) increased 36% to $3.02 million from $2.21 million in the same period of 2010.
|
·
|
R&D, milestone and grant revenues for the first quarter increased marginally to $.59 million from $.55 million in the same period of 2010
|
·
|
The increased product and R&D revenues in the first quarter of 2011 combined to produce gross margin dollars that were $.62 million, or 47%, greater ($1.93 million vs. $1.31 million) than the gross margin dollars in the comparable period in 2010. Product gross margin increased by $.57 million, or 77% ($1.31 million vs. $.74 million), over the comparable period in 2010.
|
·
|
Research and development expenses increased by $.49 million, or 61%, to $1.29 million compared to $.80 million in the 2010 period.
|
·
|
Selling General & Administrative Expenses increased by $.11 million or 17% in the first quarter of 2011 as compared to the first quarter of 2010. This was primarily due to an increase in commissions for the milestone event achieved for our DPP® products.
|
·
|
Operating loss was approximately $.14 million in the first quarter of 2011 as compared to an operating loss in the first quarter of 2010 of $.16 million, a modest improvement. In addition, net loss was approximately $.14 million in the first quarter of 2011 as compared to a net loss in the first quarter of 2010 of $.16 million.
|
·
|
The March 31, 2011 cash balance was $2.80 million, $.66 million more than as of December 31, 2010. This was primarily due to $2.23 million in cash provided from collections of accounts receivable. Partially offsetting this cash inflow was a license payment of $.88 million.
|
·
|
Regulatory Approvals in Brazil through the Oswaldo Cruz Foundation (FIOCRUZ) – During the first quarter, as recently reported, our DPP® visceral canine leishmania ("VL") rapid test was approved by Brazil’s Ministry of Agriculture, Livestock and Food Supply ("MAPA"). In April FIOCRUZ received approval from ANVISA for one of the two DPP® Syphilis tests we have under contract with them. We believe FIOCRUZ will receive during 2011 the required approvals from ANVISA for the second DPP® Syphilis test and the DPP® Leptospirosis test, although there can be no assurance of this. We are now manufacturing for confirmed orders for all four of the DPP® products now approved in Brazil and we look forward to providing an update on our anticipated shipments to FIOCRUZ.
|
·
|
FDA Approval for DPP® HIV 1/2 Screening Assay for Oral Fluid - We have collected over 2/3 of the clinical data required for submission to the FDA. As recently reported, we began submitting the PMA (Pre-Marketing Approval) application using the Modular PMA option, and we have thus far submitted the module containing the manufacturing information for this product. We anticipate filing the remaining modules during 2011, although there can be no assurance of this.
|
·
|
DPP® Syphilis Screen & Confirm - We are engaged in a number of activities oriented to commercializing this product. We anticipate commencing clinical trials and other activities in support of a planned 510(K) clearance during the second quarter of 2011.
|
·
|
DPP® Influenza – We have made significant progress on our multiplex test for FLU A/B Antigen Detection and we are verifying the performance of our prototype in order to begin full validation and commencement of regulatory activities for this product. Our current plan is still for product verification and validation to be completed during the second quarter of 2011 and for our clinical studies to be initiated during the balance of 2011.
|
·
|
DPP® Tuberculosis – As reported in February, we were awarded a three-year $2.9 million Small Business Innovative Research (SBIR) Phase II grant from the United States National Institutes of Health (NIH) to continue development of a simple, rapid, accurate, and cost-effective serological test for active tuberculosis that can be utilized in resource-limited settings.
|
·
|
DPP® Hepatitis C and DPP® Hepatitis C/HIV Oral Fluid Antibody Tests – Various prototypes of these products are being developed and evaluated internally and externally, including a laboratory study that was organized by the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) at the CDC, and field study that is commencing soon. We have received the confidential results of the laboratory study which CDC is submitting for publication and we are continuing to pursue development activity.
|
·
|
CE Mark for FDA-approved HIV tests –The final studies for the CE Marking requirements are underway for our two FDA-approved rapid HIV tests, and the study is expected to be completed during the second quarter of 2011. Submission of the final data will occur shortly thereafter.
|
Chembio Diagnostics, Inc.
|
||||||||
Summary of Results of Operations
|
||||||||
For the three months ended (Unaudited)
|
||||||||
March 31, 2011
|
March 31, 2010
|
|||||||
Net product sales
|
$ | 3,015,063 | $ | 2,214,897 | ||||
License and royalty revenue
|
28,854 | 21,496 | ||||||
R&D, milestone and grant revenue
|
591,764 | 547,022 | ||||||
TOTAL REVENUES
|
$ | 3,635,681 | $ | 2,783,415 | ||||
GROSS MARGIN
|
$ | 1,926,342 | $ | 1,306,374 | ||||
Research and development expenses
|
$ | 1,290,142 | $ | 800,758 | ||||
Selling, general and administrative expenses
|
$ | 775,371 | $ | 661,848 | ||||
LOSS FROM OPERATIONS
|
$ | (139,171 | ) | $ | (156,232 | ) | ||
NET LOSS
|
$ | (142,297 | ) | $ | (157,326 | ) | ||
Basic and diluted loss per share
|
$ | (0.00 | ) | $ | (0.00 | ) | ||
Weighted average number of shares outstanding, basic and diluted
|
62,284,772 | 61,986,165 |
Chembio Diagnostics, Inc.
|
||||||||
Summary of Balance Sheets
|
||||||||
March 31, 2011
|
Dec 31, 2010
|
|||||||
(Unaudited)
|
||||||||
CURRENT ASSETS:
|
||||||||
Cash and cash equivalents
|
$ | 2,797,103 | $ | 2,136,351 | ||||
Accounts receivable, net of allowance for doubtful accounts of $20,000 and $35,000 for 2011 and 2010, respectively
|
1,726,517 | 3,946,398 | ||||||
Inventories
|
1,592,070 | 1,349,161 | ||||||
Prepaid expenses and other current assets
|
175,814 | 204,824 | ||||||
TOTAL CURRENT ASSETS
|
6,291,504 | 7,636,734 | ||||||
FIXED ASSETS, net of accumulated depreciation
|
772,290 | 813,214 | ||||||
OTHER ASSETS
|
||||||||
License agreements and other assets
|
611,226 | 636,226 | ||||||
$ | 7,675,020 | $ | 9,086,174 | |||||
TOTAL CURRENT LIABILITIES
|
$ | 1,759,620 | $ | 3,076,457 | ||||
TOTAL OTHER LIABILITIES
|
179,654 | 200,773 | ||||||
TOTAL LIABILITIES
|
1,939,274 | 3,277,230 | ||||||
TOTAL STOCKHOLDERS’ EQUITY
|
5,735,746 | 5,808,944 | ||||||
$ | 7,675,020 | $ | 9,086,174 | |||||
Chembio Diagnostics, Inc.
|
||||||||||||
Summary of Cash Flow
|
||||||||||||
For the three months ended (Unaudited)
|
||||||||||||
March 31, 2011
|
March 31, 2010
|
|||||||||||
Net cash provided by (used in) operating activities
|
$ | 1,560,142 | $ | (192,074 | ) | |||||||
Net cash used in investing activities
|
(46,358 | ) | (72,866 | ) | ||||||||
Net cash used in financing activities
|
(853,032 | ) | (5,372 | ) | ||||||||
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
$ | 660,752 | $ | (270,312 | ) | |||||||
# # #
|
•
|
Chembio Overview
|
•
|
Develops, Manufactures and Markets Rapid Point of Care Test (POCT) Products Serving Global Markets
|
•
|
Diverse & Growing Pipeline of Proprietary Products
|
•
|
Fully Integrated FDA Approved Manufacturing Facility in NY
|
•
|
Record Financial Results 2009 & 2010
|
·
|
Five Year Compounded Annual Revenue Growth of 33%
|
·
|
Simplified Capital Structure 12/2007
|
·
|
Retired ~$2MM debt Jan. 2009 – Jan. 2011
|
·
|
Record Revenues and Improved Operating Results Year after Year
|
·
|
Near and Long-Term Growth Catalysts
|
•
|
$7B Global Point-of-Care Test (POCT) Market
|
•
|
Fastest Growing Segment of $39.5B In-Vitro Diagnostics Market
|
•
|
POCTs for HIV, Syphilis, HCV and other STDs Serve Crucial Public Health Objectives
|
•
|
Other Important POCT Markets
|
o
|
Infectious Diseases, Cardiac Markers, Companion Animal, OTC, Allergy
|
•
|
Independent Sample Flow Path Enables Improved Sensitivity & Use of More Challenging Sample Types
|
•
|
Improved Multiplexing Facilitated by Direct Binding, Uniform Delivery of Samples
|
•
|
U.S. patents, and patents in China, Malaysia, Eurasia, Mexico, Singapore, and the U.K.
|
o
|
Additional DPP® Patents in the U.S. and many foreign countries
|
o
|
Patents have also been filed on extensions to the DPP® product line
|
·
|
25% of 1.1MM HIV+ Individuals in U.S. Not Aware of their Status
|
·
|
US Rapid HIV Test Market Growth Continuing as States Implement CDC Testing Recommendation
|
·
|
Only Two Other CLIA-waived Products
|
·
|
Products Sold Under Chembio Brands (STAT PAK® & SURE CHECK®)ex-US and by Alere, Inc. (formerly Inverness) in US.
|
2011
|
2012
|
US Market
|
|
DPP® HIV Oral Fluid
|
Clinical Trials Commenced 2010, Completing Q1 & 2; Modular Submissions in Q1, 2 & 3
|
FDA Approval, CLIA waiver, US Market Launch
|
$70MM
|
DPP® Syphilis Screen & Confirm
|
Completing Validation Q1; Clinical Trials Q2-4
|
FDA Clearance & US Market Launch – Q1-2
|
$30MM
|
Dual DPP ® HCV Ag/Ab
|
R&D
|
R&D
|
TBD
|
DPP® Influenza A/B Antigen Detection
|
Completing R&D Q1, Validation Q2; Clinical Trials Q3-4
|
FDA Clearance & US Market Launch – Q1-2
|
$200MM
|
Contract
|
2010
|
2011
|
Minimum Product Sales Req. to Complete Tech Transfer*
|
DPP® HIV Screening
|
Approved,
Commercial Sales
|
Commercial Sales
|
$8.8MM
|
DPP® HIV Confirmatory
|
Approved
|
Commercial Sales
|
$4.7MM
|
DPP® Syphilis Treponemal
|
Agreement Signed
December 2010
|
Approval, Commercial Sales
|
$7.4MM
|
DPP® Syphilis Treponemal/
Non-Treponemal
|
Submission, Approval
|
||
DPP® Canine Leishmaniasis
|
Submitted
|
Approved Q1'11, Commercial Sales
|
$2.1MM
|
DPP® Leptospirosis
|
Submission pending
|
Submission, Approval, Commercial Sales
|
$0.4MM
|
Project
|
Activity
|
Multiplex DPP® Product Developed for & Licensed to Bio-Rad Laboratories, Inc.
|
Development completed. Anticipate CE Mark EOY 2011 – Launch EU early 2012. Manufacturing by Bio-Rad. Royalties Upon Commercial Sales
|
Multiplex Influenza Immune Status Product Developed for Battelle/CDC
|
Prototype Development Completed; Prototype products being evaluated at CDC. Additional development work under consideration.
|
NIH Phase II Grant – Leptospirosis
|
$2.9MM 3 Year Grant awarded 6/2009. Prototype Developed. Further reagent discovery underway. Approximately $1.7MM funding remaining in 2011 and 2012 if renewed as anticipated. Chembio is principal grantee.
|
NIH Phase II Grant –
Tuberculosis
|
$2.9MM, 3 Year Grant awarded Effective 3/1/2011. Prototype Developed. Planning Multi-site Evaluations and Optimization, Validation and Commercialization. Chembio is principal grantee.
|
Veterinary Diagnostic Applications
|
Preliminary Discussions
|
Platform Enhancements
|
Buffer Integration and “Dual DPP®” projects in progress
|
•
|
Record Revenues and Earnings
|
•
|
Improving Gross Margins
|
•
|
Controlled Operating Expenses
|
•
|
Operating Cash Flow Strengthened Balance Sheet
|
·
|
Steady increases in Revenue and Gross Profit
|
·
|
Increased R&D expense in Q1’11 driven partially by increased Clinical Trials expense
|
·
|
Steadily improving new loss in Q1
|
($ in millions)
|
Mar.’11
|
Dec. '10
|
Dec. '09
|
Dec. ‘08
|
||||||||||||
Cash
|
$ | 2,797 | 2,136 | 1,068 | 1,212 | |||||||||||
Accounts Receivable
|
1,727 | 3,946 | 1,776 | 809 | ||||||||||||
Inventories
|
1,592 | 1,349 | 1,556 | 1,819 | ||||||||||||
Total Current Assets
|
176 | 205 | 4,667 | 4,068 | ||||||||||||
Net Fixed Assets
|
772 | 813 | 580 | 881 | ||||||||||||
Other Assets
|
611 | 636 | 1,068 | 968 | ||||||||||||
Total Assets
|
$ | 7,675 | 9,086 | 6,315 | 5,915 | |||||||||||
Total Current Liabilities
|
1,760 | 3,076 | 3,173 | 2,402 | ||||||||||||
Total Liabilities
|
1,939 | 3,277 | 3,227 | 3,338 | ||||||||||||
Total Equity
|
5,736 | 5,809 | 3,088 | 2,577 | ||||||||||||
Total Liabilities & Shareholders Equity
|
7,675 | 9,086 | 6,315 | 5,915 |
•
|
Clinical & Regulatory Programs for Branded Products
|
‐
|
HIV PMA Modular Submissions
|
‐
|
Syphilis Clinical Trials
|
‐
|
Influenza Clinical Trials
|
•
|
Four OEM Product Approvals for and Product Sales to FIOCRUZ
|
•
|
New R&D & OEM Product Agreements
|
•
|
Continued US Lateral Flow HIV Test Market Share Gains & Potential New International Market Opportunities
|
Lawrence Siebert, CEO & Chairman
|
Richard Larkin, CFO
|
Javan Esfandiari, Sr. VP R&D
|
Rick Bruce, VP Operations
|
Tom Ippolito, VP Reg., QA/QC
|
Sandy Speer, Dir. Client Serv.
|
Dr. Gary Meller, Director
|
Katherine Davis, Director
|
Ticker Symbol (OTC-QB)
|
CEMI.QB
|
Price 4/29/2011
|
$0.48
|
52-Week High
|
$0.580
|
52-Week Low
|
$0.159
|
Outstanding Shares
|
63.1
|
Market Capitalization
|
$36.6
|
Fully Diluted Shares
|
70.2
|
Management Holding
|
11.2
|
Average Daily Volume (3 months)
|
105,000
|
Options and Warrants
|
Amt.
|
Avg. Ex. Price
|
Options
(3.64MM held by mgmt. & board)
|
5.21
|
$0.166
|
Warrants
(1.75 expire 10/2011)
|
1.83
|
$0.503
|
Total Options & Warrants
|
8.24
|
.267
|
March 31,
2011
|
March 31,
2010
|
December 31,
2010
|
December 31,
2009
|
December 31,
2008
|
||||||
TOTAL REVENUES
|
$ 3,635,681
|
$ 2,783,415
|
$ 16,704,703
|
$ 13,834,248
|
$ 11,049,571
|
|||||
GROSS MARGIN
|
1,926,342
|
53%
|
1,306,374
|
47%
|
8,100,699
|
48%
|
5,860,405
|
42%
|
3,851,721
|
35%
|
OPERATING COSTS:
|
||||||||||
Research and development expenses
|
1,290,142
|
35%
|
800,758
|
29%
|
2,586,308
|
15%
|
2,883,696
|
21%
|
2,605,343
|
24%
|
Selling, general and administrative expense
|
775,371
|
21%
|
661,848
|
24%
|
2,940,721
|
18%
|
2,659,382
|
19%
|
3,317,046
|
30%
|
2,065,513
|
1,462,606
|
5,527,029
|
5,543,078
|
5,922,389
|
||||||
INCOME (LOSS) FROM OPERATIONS
|
(139,171)
|
(156,232)
|
2,573,670
|
317,327
|
(2,070,668)
|
|||||
OTHER INCOME (EXPENSES):
|
(3,126)
|
(1,094)
|
(60,326)
|
(8,267)
|
121,898
|
|||||
NET INCOME (LOSS)
|
(142,297)
|
-4%
|
(157,326)
|
-6%
|
2,513,344
|
15%
|
309,060
|
2%
|
(1,948,770)
|
-18%
|
·
|
Improved Performance vs. Only Oral Fluid Test Based on Multiple Studies
|
·
|
OTC Opportunity
|
·
|
US Clinical Trials Being Completed Q1-2 2011
|
o
|
Modular PMA Submission in Q1, 2, 3
|
o
|
Anticipated Approval 2012
|
•
|
First POCT in US for Syphilis
|
•
|
All Pregnant Women Tested for Syphilis
|
•
|
Current Laboratory Tests Inadequate
|
•
|
Enables Confirmation & Treatment At POC
|
•
|
International Evaluation Ongoing in China
|
•
|
Anticipate FDA Clearance in early 2012
|
•
|
Large Established Market for Flu A&B tests
|
•
|
Chembio’s First Antigen Detection Test with DPP®
|
•
|
Prototype Shows Improved Performance vs. Established Tests
|
•
|
Anticipate FDA Clearance mid-2012
|
•
|
Estimated 3MM HCV Infections in US
|
•
|
No HCV Point-of-Care Test in US Testing for Antigen (indicating active disease)
|
•
|
Chembio Participating in Various Studies to Assess Prototype Performance
|
•
|
R&D Continuing in 2011
|
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