UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
________________________________
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
DATE OF REPORT (Date of earliest event reported): October 29, 2013
IGI LABORATORIES, INC.
(Exact name of registrant as specified in charter)
DELAWARE | 001-08568 | 01-0355758 |
105 Lincoln Avenue
Buena, New Jersey 08310
(Address of principal executive offices)(Zip Code)
(856) 697-1441
(Registrants telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
[ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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[ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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[ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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[ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Item 2.02.
Results of Operations and Financial Condition.
On October 29, 2013, IGI Laboratories, Inc. (the "Company") issued a press release announcing the Company's earnings for the third quarter ended September 30, 2013 and certain other information. A copy of the press release is attached hereto as Exhibit 99.1. The information, including Exhibit 99.1, in this Form 8-K is being furnished and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that Section. The information in this Form 8-K shall not be incorporated by reference into any filing under the Securities Act of 1933, except as shall otherwise be expressly set forth by specific reference in such filing.
Item 9.01.
Financial Statements and Exhibits.
(d) The following exhibits are furnished with this Form 8-K:
Exhibit No.
Description
99.1
Press Release of IGI Laboratories, Inc. dated October 29, 2013
2
SIGNATURE
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.
| IGI LABORATORIES, INC. | |
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Date: October 29, 2013 | By: | /s/ Jenniffer Collins |
| Name: | Jenniffer Collins |
| Title: | Chief Financial Officer |
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EXHIBIT INDEX
Exhibit |
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99.1 |
| Press Release of IGI Laboratories, Inc. dated October 29, 2013 |
4
Exhibit 99.1
News From:
Release Date: October 29, 2013
Contact:
Jenniffer Collins
IGI Laboratories, Inc.
(856) 697-1441
www.igilabs.com
IGI LABORATORIES ANNOUNCES THIRD QUARTER 2013 RESULTS
BUENA, NJ - (PR NEWSWIRE) IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based topical generic drug development and manufacturing company, announced its financial results for the third quarter ended September 30, 2013.
Third Quarter and Year to Date 2013 Highlights
Total revenues of $4.0 million in the third quarter of 2013, an increase of 100% over the same quarter in 2012
Total revenues of $11.5 million for the nine months ended September 30, 2013, an increase of 84% over the same period in 2012
Total net revenues generated from the sale of IGI label generic topical pharmaceutical products for the three and nine months ended September 30, 2013 were $1.4 million, and $4.2 million, respectively
Gross profit remained consistent year over year, equaling 31.0% for the nine months ended September 30, 2013 from 31.7% in the same period of 2012
IGI filed its eleventh and twelfth Abbreviated Drug Application, or ANDA, with the U.S. Food and Drug Administration (FDA) on July 24, 2013 and September 18, 2013 respectively
Net loss was $0.1 million and $1.4 million in the third quarter of 2013 and 2012, respectively
Net loss included research and development costs of $0.7 million and $0.6 million in the third quarter of 2013 and 2012, respectively
Net loss was $0.8 million and $2.7 million for the nine months ended September 30, 2013 and 2012, respectively
IGIs President and Chief Executive Officer, Jason Grenfell-Gardner, stated, Our team has done a tremendous job this quarter. This quarter marks the fifth consecutive quarter of top line growth. Our net loss is rapidly approaching break even for the first time at IGI in over twenty-two quarters. We have solidified our market position in our first three IGI labeled topical pharmaceutical products, and we have successfully launched our fourth product, econazole nitrate cream 1%, which we acquired earlier this year, during the third quarter of 2013. Mr. Grenfell-Gardner continued, Our research and development team has now filed four ANDAs in 2013, which brings our total filings pending with the US FDA to twelve. Based on current IMS data, the addressable market for our pipeline of twelve ANDAs, pending approval at the US FDA is estimated at over $300 million. Our team is committed to our plan to file at least six ANDAs in 2013. We believe we are on track to at least double our 2012 total revenue and achieve profitability in 2013.
The Company will hold a conference call today at 4:30 pm ET to discuss 3rd quarter 2013 results.
The Company invites you to listen to the call by dialing 1-877-415-3182. International participants should call 1-857-244-7325. The passcode for the conference call is 58610371.
This call is being webcast by Thomson and can be accessed at IGI's website at www.igilabs.com.
The webcast is also being distributed through the Thomson StreetEvents Network. Individual investors can listen to the call at www.earnings.com, Thomson's individual investor portal, powered by StreetEvents (www.streetevents.com), a password-protected event management site.
IGI LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share information)
(Unaudited)
| Three months ended September 30, |
| Nine months ended September 30, | |||||
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| 2013 |
| 2012 |
| 2013 |
| 2012 |
Revenues: |
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Product sales, net |
| $ 3,950 |
| $ 1,464 |
| $ 11,124 |
| $ 4,835 |
Research and development income |
| 10 |
| 496 |
| 278 |
| 1,368 |
Licensing, royalty and other income |
| 35 |
| 26 |
| 97 |
| 52 |
Total revenues |
| 3,995 |
| 1,986 |
| 11,499 |
| 6,255 |
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Cost and expenses: |
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Cost of sales |
| 2,684 |
| 1,222 |
| 7,932 |
| 4,271 |
Selling, general and administrative expenses |
| 692 |
| 980 |
| 2,078 |
| 2,254 |
Product development and research expenses |
| 661 |
| 620 |
| 2,123 |
| 1,735 |
Total costs and expenses |
| 4,037 |
| 2,822 |
| 12,133 |
| 8,260 |
Operating loss |
| (42) |
| (836) |
| (634) |
| (2,005) |
Interest expense and other, net |
| (53) |
| (586) |
| (121) |
| (740) |
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Net loss |
| $ (95) |
| $ (1,422) |
| $ (755) |
| $ (2,745) |
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Basic and diluted loss per share |
| $ (0.00) |
| $ (0.04) |
| $ (0.02) |
| $ (0.07) |
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Weighted Average of Common Stock and Common Stock Equivalents Outstanding |
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Basic and diluted | 43,395,980 | 39,508,217 | 43,179,898 | 39,510,540 |
IGI LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For the nine months ended September 30, 2013 and 2012
(in thousands)
(Unaudited)
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| 2013 |
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| 2012 |
Cash flows from operating activities: |
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Net loss | $ | (755) |
| $ | (2,745) |
Non-cash expenses |
| 671 |
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| 1,388 |
Changes in operating assets and liabilities |
| (1,307) |
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| 156 |
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Net cash used in operating activities |
| (1,391) |
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| (1,201) |
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Cash flows from investing activities: |
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Product acquisition costs |
| (1,826) |
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| - |
Capital expenditures |
| (223) |
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| (323) |
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Net cash used in investing activities |
| (2,049) |
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| (323) |
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Net cash provided by financing activities |
| 2,306 |
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| 385 |
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Net decrease in cash and cash equivalents |
| (1,134) |
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| (1,139) |
Cash and cash equivalents at beginning of period |
| 2,536 |
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| 2,914 |
Cash and cash equivalents at end of period | $ | 1,402 |
| $ | 1,775 |
IGI LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share information)
|
| September 30, |
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| December 31, |
ASSETS |
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Current assets: |
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Cash and cash equivalents | $ | 1,402 |
| $ | 2,536 |
Accounts receivable, net |
| 2,895 |
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| 1,577 |
Inventories |
| 2,523 |
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| 1,773 |
Prepaid expenses and other receivables |
| 232 |
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| 253 |
Total current assets |
| 7,052 |
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| 6,139 |
Property, plant and equipment, net |
| 2,634 |
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| 2,691 |
Product acquisition costs, net |
| 1,796 |
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| - |
Restricted cash, long term |
| 54 |
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| 54 |
License fee, net |
| 225 |
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| 300 |
Debt issuance costs, net |
| 77 |
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| 100 |
Other |
| 155 |
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| 143 |
Total assets | $ | 11,993 |
| $ | 9,427 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable | $ | 1,561 |
| $ | 1,091 |
Accrued expenses |
| 1,079 |
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| 820 |
Deferred income, current |
| 179 |
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| 48 |
Capital lease obligation, current |
| 8 |
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| 17 |
Total current liabilities |
| 2,827 |
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| 1,976 |
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Note payable, bank |
| 3,000 |
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| 1,000 |
Deferred income, long term |
| 6 |
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| 20 |
Capital lease obligation, long term |
| - |
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| 4 |
Total liabilities |
| 5,833 |
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| 3,000 |
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Commitments and contingencies |
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Stockholders equity: Series A Convertible Preferred stock, liquidation preference - $0 and $500,000 at September 30, 2013 and December 31, 2012 |
| - |
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| 500 |
Series C Convertible Preferred stock, liquidation preference - $1,822,205 at September 30, 2013 and $1,764,240 at December 31, 2012 |
| 1,517 |
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| 1,517 |
Common stock |
| 457 |
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| 446 |
Additional paid-in capital |
| 48,386 |
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| 47,409 |
Accumulated deficit |
| (44,200) |
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| (43,445) |
Total stockholders equity |
| 6,160 |
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| 6,427 |
Total liabilities and stockholders' equity | $ | 11,993 |
| $ | 9,427 |
* Derived from the audited December 31, 2012 financial statements
About IGI Laboratories, Inc.
IGI Laboratories is a developer and manufacturer of topical formulations for the pharmaceutical, OTC, and cosmetic markets. Our mission is to be a leading player in the generic topical prescription drug market.
IGI Laboratories, Inc. Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995. This press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, plans, objectives, expectations and intentions, and other statements contained in this press release that are not historical facts and statements identified by words such as " will," believe, target, estimated, "continue" or words of similar meaning. These statements are based on our current beliefs or expectations and are inherently subject to various risks and uncertainties, including those set forth under the caption "Risk Factors" in IGI Laboratories, Inc.s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Actual results may differ materially from these expectations. Factors that could cause actual results to differ materially from these expectations include, but are not limited to: our inability to meet current or future regulatory requirements in connection with existing or future ANDAs; our inability to achieve profitability; our failure to obtain FDA approvals as anticipated; our inability to execute and implement our business plan and strategy; the potential lack of market acceptance of our products; our inability to protect our intellectual property rights; changes in global political, economic, business, competitive, market and regulatory factors; and our inability to complete successfully future product acquisitions. IGI Laboratories, Inc. does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
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