Teligent, Inc. (NASDAQ:TLGT)

First Quarter 2015 Results

• Total revenues of $10.7 million in the first quarter of 2015, an increase of 56% over the same quarter in 2014
• Adjusted net income per fully diluted share for the three months ended March 31, 2015 and 2014 was $0.00 and $0.01, respectively

IGI's President and Chief Executive Officer, Jason Grenfell-Gardner, stated, "Consistent with our expectations, based on historical trends in our portfolio and significant incremental sales in the fourth quarter of 2014, we experienced a decline in first quarter revenue as compared to the fourth quarter of 2014. Looking forward, as a result of recent changes in our customer mix and market pricing, particularly for econazole nitrate, we anticipate revenue from our econazole nitrate cream products to decline in the second quarter of 2015. While the impact of this change has not fully taken effect, we now expect second quarter 2015 revenue in a range of $7.0 to $8.0 million. As we continue to evaluate and respond to these changes, we intend to update the investment community as quickly as practical to share our outlook on the market and any adjustments to our business that we see necessary to provide updated guidance for the full year 2015."

Mr. Grenfell-Gardner continued, "These changes in the market dynamics of one product in the short term will not distract us from our dedication to the creation of long-term shareholder value through the execution of our TICO strategy to expand our presence in the topical, injectable, complex and ophthalmic markets. We still believe that 2015 is the year dedicated to building our foundation, focused on the advancement of our research and development pipeline. We believe that we are making good progress on the injectable and ophthalmic product projects, as well as our first 505(b)2 topical project, so we are actively pursuing all areas of our TICO strategy. As of today, we have twenty-four ANDAs pending with the FDA. Based on February 2015 IMS Health data, the addressable market for our pipeline of twenty-four ANDAs, pending approval by the FDA, is estimated at $702 million. Our team has now filed its first two ANDAs for 2015, and is on target to file at least another four in the second quarter of 2015. Including the products currently on stability, our team has almost doubled productivity over this time last year, and we expect to be on target to file 20 topical ANDA submissions in 2015."

BUENA, N.J., March 26, 2015 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based specialty generic pharmaceutical company, today announced it has submitted its first abbreviated new drug application (ANDA) to the U.S. Food and Drug Administration (FDA) of 2015, which brings the Company's total number of ANDA submissions now pending at the FDA to twenty-three.

Jason Grenfell-Gardner, President and CEO of the Company, commented, "On March 2, 2015, we committed to file at least twenty ANDAs in 2015.  We believe the ANDA filed today has an addressable market of $20 million based on January 2015 data from IMS Health.  We believe our current pipeline of submissions, exclusive of partnered submissions, pending approval by the FDA now has a combined addressable market of over $623 million based on January 2015 data from IMS Health."

BUENA, N.J., Dec. 23, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based specialty generic pharmaceutical company, today announced it has submitted three additional abbreviated new drug applications (ANDAs) to the U.S. Food and Drug Administration (FDA), which brings the Company's total number of ANDA submissions in 2014 to eleven, with twenty-two submissions now pending at the FDA.

Jason Grenfell-Gardner, President and CEO of the Company, commented, "In February of 2014, we committed to file ten ANDAs in 2014. After today's ANDA submissions, we have submitted eleven applications to the FDA in 2014. I am extremely proud of the dedication and accountability of our team- we made commitments and we delivered.  Our TICO strategy is focused on the topical, injectable, complex and ophthalmic prescription markets. The topical development engine is running smoothly, and we expect to average one to two topical ANDA submissions per month in 2015. We believe the three ANDAs filed today have a combined addressable market of $39 million based on October 2014 data from IMS Health. We believe our current pipeline of submissions, exclusive of partnered submissions, pending approval by the FDA now has a combined addressable market of over $551 million based on October 2014 data from IMS Health."

BUENA, N.J., Dec. 11, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG; "IGI" or the "Company") announced today the pricing of its $125 million aggregate principal amount of 3.75% Convertible Senior Notes due 2019 (the "Notes") in a private placement. The Notes will be offered by the initial purchasers only to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). IGI has also granted to the initial purchasers of the Notes a 30-day option to purchase up to an additional $18.75 million aggregate principal amount of the Notes.

The sale of the Notes is expected to settle on December 16, 2014, subject to the satisfaction of customary closing conditions, and is expected to result in approximately $120.5 million net proceeds to IGI, assuming no exercise of the initial purchasers' option to purchase additional Notes, (or approximately $138.70 million if the initial purchasers exercise their option to purchase additional Notes in full) after deducting fees and the estimated offering expenses payable by IGI.

The Notes will be senior unsecured obligations of IGI, and will bear interest at a fixed rate of 3.75% per year, payable semiannually in arrears on June 15 and December 15 of each year, beginning on June 15, 2015.  The Notes will mature on December 15, 2019, unless earlier converted, repurchased or redeemed.

The Notes will be convertible by the holders beginning on September 15, 2019, or earlier, upon specified events, and upon conversion, the holders will receive, at IGI's option, shares of IGI's common stock, cash or a combination thereof.  However, if IGI has not received stockholder approvals to increase the number of authorized shares of IGI's common stock and comply with certain listing standards of the NYSE MKT, IGI would be required to satisfy any conversion obligations solely in cash or, at IGI's option subject to certain conditions and limitations, in shares of IGI's common stock.

The Notes will be convertible at an initial conversion price of approximately $11.29 per share, which is equivalent to an initial conversion rate of 88.5716 shares per $1,000 principal amount of Notes, subject to adjustment in certain events, such as distributions of dividends or stock splits. This represents a conversion premium of approximately 27.0% over the closing price of IGI's common stock of $8.89 per share on December 10, 2014, as reported on the NYSE MKT. Following certain corporate events that occur prior to the maturity date, IGI will increase the conversion rate for a holder who elects to convert the Notes in connection with such a corporate event in certain circumstances. Additionally, subject to certain conditions, the Company may redeem for cash any or all outstanding Notes on or afterDecember 19, 2017 in an amount equal to the outstanding principal amount of such Notes, plus accrued and unpaid interest.

IGI intends to use the net proceeds from the sale of the Notes for general corporate purposes, including, without limitation, capital expenditures and potential future acquisitions and strategic transactions. IGI has no pending agreement or understanding with respect to any such acquisition or transaction.

The Notes are being offered to qualified institutional buyers pursuant to Rule 144A under the Securities Act. Neither the Notes nor any common stock issuable upon conversion of the Notes, if any, have been registered under the Securities Act, applicable state securities laws or the securities laws of any other jurisdiction and may not be offered or sold in the United States without registration or an applicable exemption from registration requirements. IGI does not intend to file a registration statement for the resale of the Notes or any common stock issuable upon conversion of the Notes.

BUENA, N.J., Dec. 1, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based specialty generic pharmaceutical company, today announced it has submitted an additional abbreviated new drug application (ANDA) to the U.S. Food and Drug Administration (FDA), which brings the Company's total number of ANDA submissions in 2014 to eight, with nineteen submissions now pending at the FDA.

Jason Grenfell-Gardner, President and CEO of the Company, commented, "Consistent with our commitment we made to our shareholders at the beginning of 2014, we are on track to submit at least 10 ANDAs in 2014.  We now have nineteen ANDAs pending approval and on file with the FDA, in addition to four more ANDAs pending approval under joint development agreements with our partners.  We plan to file another two to three ANDAs before the end of 2014. We believe our current pipeline of submissions, exclusive of partnered submissions, pending approval by the FDA has a combined addressable market of over $495 million based on recent data from IMS Health."

BUENA, N.J., Nov. 24, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based specialty generic pharmaceutical company, today announced it has submitted an additional abbreviated new drug application (ANDA) to the U.S. Food and Drug Administration (FDA), which brings the Company's total number of ANDA submissions in 2014 to seven, with eighteen submissions now pending at the FDA.

Jason Grenfell-Gardner, President and CEO of the Company, commented, "Our team here at IGI has continued to deliver on the development front.  We now have eighteen ANDAs pending approval and on file with the FDA, in addition to four more ANDAs pending approval under joint development agreements with our partners.  This should be the first of several ANDAs we file in this quarter, as we plan to file another three to four ANDAs before the end of 2014. We believe our current pipeline of submissions, exclusive of partnered submissions, pending approval by the FDA has a combined addressable market of over $470 million based on recent data from IMS Health."

Third Quarter 2014 Results:

• Total revenues of $6.7 million in the third quarter of 2014, an increase of 67% over the same quarter in 2013 of $4.0 million.
• Q3 2014 EPS of $0.00 vs $0.00 in the prior year and ahead of analyst estimates of a loss of $0.01.

IGI's President and Chief Executive Officer, Jason Grenfell-Gardner, stated, "At the beginning of 2014, we said this would be a year of transformation for IGI, and as we end the third quarter, we believe that we have delivered on that promise. The two acquisitions we completed at the end of September are initial drivers of a broader strategy to become a leader in the specialty generic pharmaceutical drug market. While we will continue expanding our reach into the topical market, we will also pursue targeted opportunities in the injectable, complex and ophthalmic generic pharmaceutical markets. We call this our TICO strategy, as it represents our strategic focus to leverage our assets and expertise across the topicals, injectables, complex and ophthalmic spaces. As of today, we have seventeen ANDAs pending at the FDA, with an addressable market of over $465 million as of August 2014, and four additional ANDAs, which we have filed with three of our pharmaceutical partners under joint development agreements." Mr. Grenfell-Gardner continued, "We increased total revenue by 67% over the same quarter last year, and improved margins to end the third quarter of 2014 with a gross margin of 42%, which included our adjustment to net revenue of just over $3.8 million related to price protection for our customers after our price increase for econazole nitrate cream 1% took effect in September. We expect to be on schedule to file at least ten ANDAs by the end of 2014. We forecast net revenue for 2014 to be $31.5 to $33.0 million, gross margin for 2014 to approximate 50% and net income for the full year to range between $2.0 and $3.0 million."

BUENA, N.J., Oct. 1, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based specialty generic pharmaceutical company, today announced it has acquired two previously marketed ophthalmic drug products, in addition to the right to acquire three additional previously marketed injectable drug products from affiliates of Valeant Pharmaceuticals International, Inc. after the completion of the due diligence process.   All of these products have been approved by the FDA as abbreviated new drug applications (ANDAs) or new drug applications (NDAs). According to IMS Health, the current addressable market in the United States for the therapeutic areas that all of these products were previously indicated for is estimated at $38 million as of August 2014.

Jason Grenfell-Gardner, President and CEO of IGI, commented, "We expect that this acquisition will allow us to continue to execute our strategy to be a leader in the specialty generic pharmaceutical drug market.  This opportunity will allow IGI to leverage almost all of the various areas of the IGI value chain, including sales and distribution, logistics, regulatory services, and our existing support structure.  We hope to have these products in the market under our IGI label by the end of 2015."

BUENA, N.J., Sept. 25, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based specialty generic pharmaceutical company, today announced it has acquired the regulatory rights and related documents and records for 18 drug products from AstraZeneca, 17 of which were marketed. The acquisition includes the regulatory rights and documents for 17 injectable products and 1 suppository product. All of these products had been previously approved by the US FDA as abbreviated new drug applications (ANDAs) or new drug applications (NDAs) prior to their discontinuation or withdrawal from the market. According to IMS Health, the current addressable market in the United States for the therapeutic areas that these products were previously indicated for is estimated at $200 million as of May 2014.

Jason Grenfell-Gardner, President and CEO of IGI Laboratories, commented, "This acquisition begins the next critical phase of our growth strategy, and will enable us to expand our existing generic topical pharmaceutical platform to now include injectable products. Expanding our development and commercial focus to include injectable pharmaceutical products will leverage our existing expertise and capabilities, and broaden our platform for sustainable growth. Almost half of the products we acquired are currently listed on the US FDA shortage list, and we look forward to working closely with the US FDA to return these products to the market as soon as possible."

Second Quarter 2014 Results:

• Total revenues this quarter was $6.5 million, an increase of 70% from $3.8 million in the same quarter last year.
• EPS this quarter was -$0.01 vs -$0.01 in prior year.

IGI's President and Chief Executive Officer, Jason Grenfell-Gardner, stated, "The extensive list of accomplishments by the IGI team in the second quarter represents our continued focus on executing our business plan. We filed six ANDAs in the first few weeks of June, including one under a joint development agreement with Impax Laboratories, Inc. We received tentative approval of our ANDA for diclofenac sodium 1.5% topical solution in May, and we should be ready to launch the product in March 2015, after final FDA approval. As of today, we have seventeen ANDAs pending at the FDA, with an addressable market of over $465 million, and four additional ANDAs which we have filed with three of our pharmaceutical partners under joint development agreements. On the financial front, we increased total revenue 70% over the same quarter last year, and improved margins to end the second quarter of 2014 with a gross margin of 45%, compared to 30% one year ago. We continue to expect to file at least ten ANDAs in 2014, and we have accelerated our R&D efforts in order to meet our commitments." Mr. Grenfell-Gardner continued, "We continue to expect revenue to increase between 40% and 45% over 2013. We are committed to profitability for the year ended December 31, 2014, even though we plan to at least double our spending in research and development in 2014 over 2013."

BUENA, N.J. and HAYWARD, Calif., June 20, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted its seventh abbreviated new drug application (ANDA) in 2014 to the U.S. Food and Drug Administration (FDA).  The seventh ANDA submission was in connection with an existing development, supply and marketing agreement with Impax Laboratories, Inc. (NASDAQ: IPXL).  The agreement designates IGI Laboratories, Inc. (IGI) as the developer, manufacturer, and owner of a generic topical pharmaceutical drug product, which will be licensed, marketed and distributed in the United States by Global Pharmaceuticals, Impax's generics division. In accordance with the agreement, Impax is required to pay IGI when certain milestones are met related to the filing and approval of the associated ANDA. 

Jason Grenfell-Gardner, President and CEO of the Company commented, "We have collaborated with Impax over the past few years, and we are grateful for the continued support from one of the leaders in the specialty pharmaceutical industry.  We believe the addressable market for this product to be over $100 million based on recent data from IMS Health. We look forward to working with Impax to continue to help us grow our pipeline of generic topical prescription drugs."

President of Global Pharmaceuticals Dr. Carole Ben-Maimon stated, "We are pleased to be the partner of choice with IGI on this product opportunity. This is another example of our commitment to diversifying our product base and the expansion of our topical portfolio."

Also announced:

BUENA, N.J., June 20, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted two additional abbreviated new drug application (ANDA) to the U.S. Food and Drug Administration (FDA), which brings the Company's total number of ANDA submissions in 2014 to six, with seventeen submissions now pending at the FDA.

Jason Grenfell-Gardner, President and CEO of the Company, commented, "Our team has filed five ANDAs this week alone, including the ANDA we announced earlier today under a partnership with Impax Laboratories, Inc.  We set expectations for our team extremely high, and they have proven they can deliver.  We now have seventeen ANDAs pending approval and on file with the FDA, in addition to four more ANDAs pending approval under joint development agreements with our partners.  Our 2014 goal of at least ten ANDA submissions remains on track.  We believe our current pipeline of submissions pending approval by the FDA has a combined addressable market of over $465 million based on recent data from IMS Health."

BUENA, N.J., June 18, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted its third abbreviated new drug application (ANDA) in 2014 to the U.S. Food and Drug Administration (FDA), which brings the Company's total number of ANDA submissions to sixteen, with fourteen now pending at the FDA.

Jason Grenfell-Gardner, President and CEO of the Company, commented, "We now have fourteen ANDAs pending approval and on file with the FDA.  Our 2014 goal of at least ten ANDA submissions remains on track.  This is our second submission this month, and we plan to add to our pending submissions throughout this week.  We believe our current pipeline of submissions pending approval by the FDA has a combined addressable market of over $395 million based on recent data from IMS Health."

BUENA, N.J., June 2, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted its second abbreviated new drug application (ANDA) in 2014 to the U.S. Food and Drug Administration (FDA), which brings the Company's total number of ANDA submissions to fifteen, with thirteen now pending at the FDA.

Jason Grenfell-Gardner, President and CEO of the Company, commented, "We now have thirteen ANDAs pending approval and on file with the FDA.  Our 2014 goal of at least ten ANDA submissions remains on track.  We have set expectations very high, and we believe June will be the most productive month for submissions in the company's history.  Our team is focused and prepared to continue to execute. We believe our current pipeline of submissions pending approval by the FDA has a combined addressable market of over $370 million based on recent data from IMS Health."

BUENA, N.J., May 7, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced that it has received tentative approval from the U.S. Food & Drug Administration (FDA) for its abbreviated new drug application (ANDA) for diclofenac sodium topical solution, 1.5%.

Diclofenac sodium topical solution, 1.5% is a nonsteroidal anti-inflammatory drug indicated for the treatment of the pain of osteoarthritis of the knee.  Based on recent IMS Health data, the total addressable market for this product is approximately $29 million. IGI originally submitted this ANDA to the FDA in December 2010.

Jason Grenfell-Gardner, President and CEO of the Company, commented, "This tentative approval marks the second approval of an IGI ANDA by the FDA and we believe is a further validation of IGI's pipeline. The launch of this product will be conditioned on resolving the patent issues that surround the product. As a result of this approval, we now have 12 ANDAs pending at the FDA and we anticipate submitting at least a further nine ANDAs throughout the remainder of 2014."

First Quarter 2014 Results

• Revenues for the Q1 2014 were $6.9 million vs $3.7 million in the prior year period and ahead of analyst Q1 2014 revenue estimates of $6.0
• Non-Gaap EPS for Q1 2014 were $0.01 vs a loss of $0.01 in the prior year and in-line with analyst 2014 Q1EPS estimates of $0.01.

IGI's President and Chief Executive Officer, Jason Grenfell-Gardner, stated, "The first quarter represents a strong start to our year of transformation.  We received our first ANDA approval for lidocaine hydrochloride USP 4% topical solution in March.  This was a huge milestone for IGI, and validated our organic research and development expertise.  On the financial front, we increased total revenue 86 percent over the same quarter last year, and improved margins to end the first quarter of 2014 with a gross margin of 42%, compared to 30% one year ago.  As promised, we maintained profitability in the first quarter of 2014, even though we significantly increased our expenses related to research and development.  We continue to expect to file at least ten ANDAs in 2014, and we have accelerated our R&D efforts in order to meet our commitments."  Mr. Grenfell-Gardner continued, "We continue to expect revenue to increase between 40% and 45% over 2013.  We are committed to sustain profitability in 2014, even though we plan to at least double our spending in research and development in 2014 over 2013."

BUENA, N.J., March 12, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has received its first approval from the U.S. Food and Drug Administration (FDA) for an abbreviated new drug application (ANDA). The FDA has approved IGI's application for lidocaine hydrochloride USP 4% topical solution.

Lidocaine hydrochloride USP 4% topical solution is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract. Based on recent IMS Health data, the total addressable market for this product is approximately $1.8 million. IGI originally submitted this ANDA to the FDA in May, 2012.

Jason Grenfell-Gardner, President and CEO of the Company, commented, "Today's action by the FDA marks a true turning point in the transformation of IGI. With our first drug approval, organically generated from beginning to end within IGI, we have validated our team's ability to deliver on R&D. Although this particular drug is the smallest opportunity in our pipeline, it is an important milestone for demonstrating IGI's capabilities. With now 13 further applications pending, and at least nine more filings planned this year, IGI will continue to execute its R&D plan as part of our goal of being a leading player in the generic topical pharmaceutical market."

BUENA, N.J., March 3, 2014 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted its first abbreviated new drug application (ANDA) in 2014 to the U.S. Food and Drug Administration (FDA), which brings the Company's total number of ANDA submissions to fourteen.

Jason Grenfell-Gardner, President and CEO of the Company, commented, "We now have fourteen ANDAs on file with the FDA.  We believe our current pipeline of submissions pending approval by the FDA has a combined addressable market of approximately $330 million based on recent data from IMS Health.  2014 is our year of transformation, as we grow and develop into a leader in the topical generic pharmaceutical industry.  We have an aggressive target in 2014, to file ten ANDAs with the FDA, so we must stay focused as we continue to build our R&D team and maintain our forward momentum as we expand our pipeline."

Fourth Quarter 2013 Results

• Total revenues of $6.7 million in the fourth quarter of 2013, an increase of 191% over the same quarter in 2012
• Net income was $0.7 million in the fourth quarter of 2013, compared to a net loss of $1.2 million in the same period in 2012
• Loss for the fourth quarter 2013 of $0.01 compared to loss of $0.03 in prior year period

IGI's President and Chief Executive Officer, Jason Grenfell-Gardner, stated, "This year was a critical one for our team, and I believe we have delivered. At the beginning of 2013, we committed to double revenue, achieve profitability, and file at least six ANDAs. As promised, our revenues year to date were 113% higher than 2012, our fourth quarter net income totaled $0.7 million, and our year to date net loss approached break even for the first time since 1997. In addition we filed six ANDAs with the FDA in 2013." Mr. Grenfell-Gardner continued, "Our research and development team now has thirteen filings pending with the US FDA. Based on current IMS Health data, the addressable market for our pipeline of thirteen ANDAs, pending approval by the FDA is estimated at over $300 million. Our expectations for 2014 are even greater. We expect revenue to increase between 40% and 45% over 2013. We intend to sustain profitability in 2014; however, we plan to at least double our spending in research and development in 2014 over 2013 to accelerate the growth of our pipeline. Our team is committed to file at least ten ANDAs in 2014."

On December 6, 2013, we declared a preferred stock dividend of 415,118 shares of our common stock in connection with the mandatory automatic conversion of 1,550 shares of our Series C Preferred Stock into common stock. The Company originally issued 1,550 shares of Series C Convertible Preferred Stock on March 29, 2010, for which the holders were entitled to quarterly dividends at an annual rate of 5%. On December 6, 2013, the preferred stock and all accrued but unpaid dividends were required to be converted after the closing price of the Company's common stock had exceeded three times the closing price on the issuance date for a period of twenty-five consecutive trading days immediately preceding December 6, 2013. The Company issued 2.7 million shares of common stock in connection with this conversion. As a result of this non-cash preferred stock dividend in the amount of $1.3 million recognized upon the mandatory conversion of the Company's Series C preferred stock, net loss attributable to common stockholders was $1.4 million for the year ended December 31, 2013.

BUENA, N.J., Dec. 31, 2013 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it executed a license, development, supply and marketing agreement with a large multi-national pharmaceutical company.  In accordance with the confidentiality agreement in place, the name of the company remains undisclosed.  The agreement designates IGI Laboratories, Inc. (IGI) as the developer and manufacturer of a generic topical pharmaceutical drug product, which will be licensed, marketed and distributed in the United States by our partner, or its subsidiaries. The named product in the agreement was developed at IGI.  IGI has now filed the Abbreviated New Drug Application associated with the named generic pharmaceutical product.  In accordance with the agreement, our partner is required to pay IGI when certain milestones are met related to the filing and approval of the associated ANDA.  In addition, in accordance with the agreement, IGI will also receive a share of the profits following the approval and commercialization of the product.

Jason Grenfell-Gardner, President and CEO of the Company, commented, "This strategic partnership provides IGI with an opportunity to collaborate with an established generic pharmaceutical drug manufacturer.  This agreement will provide IGI with some liquidity in the near future which will help us accelerate our generic pharmaceutical research and development efforts in 2014."

BUENA, N.J., Nov. 1, 2013 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted its fifth abbreviated new drug application (ANDA) in 2013 to the U.S. Food and Drug Administration (FDA), which brings the Company's total number of ANDA submissions to thirteen.

Jason Grenfell-Gardner, President and CEO of the Company, commented, "This submission brings our total number of abbreviated new drug applications on file with the FDA to thirteen.  We believe our current pipeline of submissions pending approval by the FDA has a combined addressable market of approximately $325 million based on recent data from IMS Health.  The most recent data indicate that the market dynamics in the topical pharmaceutical industry continue to be strong.  Our successful execution and continuous expansion of our pipeline will allow us to be well positioned to fulfill our mission to be a leading player in the generic topical prescription drug market."

Third Quarter 2013 Results

• Total revenues of $4.0 million in the third quarter of 2013, an increase of 100% over the same quarter in 2012
• Net loss was $0.1 million ($0.00) and $1.4 million ($0.04) in the third quarter of 2013 and 2012, respectively

IGI's 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."

Second Quarter 2013 Results

• Total revenues of $3.8 million in the second quarter of 2013, an increase of 57% over the same quarter in 2012
• Net loss per share in the second quarter 2013 were $0.01, same as the prior year.

IGI’s President and Chief Executive Officer, Jason Grenfell-Gardner, stated, “I am extremely pleased with the progress we have made to obtain IGI’s current market position in our first three IGI labeled topical pharmaceutical products. We are ready to launch our fourth product, econazole nitrate cream 1%, which we acquired earlier this year, during the third quarter of 2013 pending final FDA approval of our site transfer. We have expanded our IGI label customer base for our existing product lines, and we continue to explore opportunities to potentially expand our product portfolio. Our formulation and manufacturing contract services revenue continued to grow, and has increased 10% over 2012 year to date.” Mr. Grenfell-Gardner continued, “Our research and development team has filed three ANDAs in 2013, one in January, one in April, and one in July, which brings our total filings pending with the US FDA to 11. Our team is committed to our plan to file at least six ANDAs in 2013. We remain on track for our target to at least double our 2012 total revenue and achieve profitability in 2013.”

BUENA, N.J.--(BUSINESS WIRE)--IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted its third abbreviated new drug application (ANDA) in 2013 to the U.S. Food and Drug Administration (FDA), which brings the Company’s total number of ANDA submissions to eleven.

Jason Grenfell-Gardner, President and CEO of the Company, commented, "Today’s submission brings our total number of abbreviated new drug applications on file with the FDA to eleven which together we believe have a combined addressable market of approximately $250 million based on recent IMS. Our research and development team remains on track to deliver on our expectation to file at least six ANDAs in 2013. We believe that our development pipeline is the strongest organic driver we have to create long term value for our shareholders, and we plan to continue to invest in our research and development efforts to accelerate the growth of our pipeline. We remain focused on the development of topical generic pharmaceutical products and are optimistic about the opportunities in these markets.”

First Quarter 2013 Results

• Total revenues of $3.7 million in the first quarter of 2013, an increase of 101% over the same quarter in 2012
• Net loss was $0.3 million and $0.7 million in the first quarter of 2013 and 2012, respectively. Net loss included research and development costs of $0.7 million and $0.5 million in the first quarter of 2013 and 2012, respectively.
• Diluted loss per share was $0.01 vs a loss of $0.02 in the prior year.

IGI’s President and Chief Executive Officer, Jason Grenfell-Gardner, stated, “The launch of our first ever IGI labeled topical pharmaceutical products has enabled us to more than double revenue compared to the first quarter of 2012. We believe that we are one step closer to our mission to become a leading player in the generic topical prescription drug market. At the same time, through the increase in orders from our pharmaceutical partners we were able to grow our formulation and manufacturing contract services revenue 24% over the first quarter of 2012. We believe that our sales strategy to increase revenue and improve our product mix resulted in an increase in gross profit to 30.1% in the first quarter of 2013, from 25.4% in the same period last year.” Mr. Grenfell-Gardner continued, “Our research and development team has filed two ANDAs in 2013, one in the first quarter in January and one in April, which should keep us on track with our plan to file at least six ANDAs in 2013. In addition, we are working on completing the transfer of econazole nitrate cream 1%, which pending FDA approval of our site transfer, will allow us to begin manufacturing another IGI labeled generic pharmaceutical product beginning in the third quarter of 2013. We remain committed to our target to at least double our 2012 total revenue and achieve profitability in 2013.”

BUENA, N.J.--(BUSINESS WIRE)--IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has submitted its second abbreviated new drug application (ANDA) in 2013 to the US FDA, which brings the company’s total number of submissions to ten.

Jason Grenfell-Gardner, President and CEO of the Company, commented, "With this submission, we remain on target to deliver on our expectation to file at least six ANDAs in 2013. The fourth quarter of 2013 will mark the three year anniversary of our first two submissions to the FDA, and based on the FDA’s current average review time of thirty-two months, we are hopeful we could receive our first ANDA approval in 2013. Our team has filed ten ANDAs in just over two years. We believe that our successful expansion of our development pipeline is the foundation of our strategy to create long term shareholder value. We will continue to look for opportunities to accelerate the growth of our product portfolio through both our research and business development efforts.”