BUENA, N.J., July 23, 2015 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey-based specialty generic pharmaceutical company, announced its financial results for the second quarter ended June 30, 2015.
Second Quarter 2015 Highlights
- Total revenues of $8.9 million in the second quarter of 2015, an increase of 37% over the same quarter in 2014
- Total net revenues generated from the sale of IGI label generic topical pharmaceutical products for the three months ended June 30, 2015 and 2014 of $6.7 million and $3.4 million, respectively
- Gross profit for the three months ended June 30, 2015 equaled 41% as compared to 45% in the same period in 2014
- IGI filed four Abbreviated New Drug Applications (ANDAs) in the second quarter of 2015 with the U.S. Food and Drug Administration (FDA)
- Operating loss was $1.9 million in the second quarter of 2015 compared to $0.3 million in the same period in 2014, primarily attributable to an increase in research and development costs of $1.4 million over the same period in 2014
- Adjusted EBITDA (as defined and reconciled to GAAP below) for the three months ended June 30, 2015 and 2014 was $(1.2) million and $0.1 million, respectively
- Adjusted net loss per fully diluted share (as defined and reconciled to GAAP below) for the three months ended June 30, 2015 and 2014 was $0.04 and $0.00, respectively
Full Year 2015 Financial Guidance
- The Company expects sequential improvement quarter over quarter in total revenue for the remainder of the year, and therefore still expects total revenue between $35.0 and $40.0 million for the year ended December 31, 2015.
- The Company anticipates sequential improvement in gross margin quarter over quarter for the remainder of the year, and therefore expects gross margin of 45% to 50% for the year ended December 31, 2015.
- The Company intends to submit up to 20 ANDAs with the FDA by the end of 2015. In order to complete all of the development work required for the 2015 filings, the Company continues to expect to spend between $13 and $14.5 million in research and development by the end of 2015.
- As a result of the expected sequential increase in total revenue in the third and fourth quarters of 2015, the Company intends to improve its operating margin to approach break even in the fourth quarter of 2015, sequentially.
IGI's President and Chief Executive Officer, Jason Grenfell-Gardner, stated, "We are pleased with our steady progress this quarter. On the regulatory front, we received the FDA's final approval for our diclofenac sodium 1.5% topical solution earlier this month. We also added another six ANDA submissions during fiscal 2015, including the submission filed today. While there have been some changes in the econazole market earlier this quarter, we have regained market share for that product again over the last two months." Mr. Grenfell-Gardner continued, "Our long-term vision continues to focus on the creation of a diversified product portfolio, built around our topical, injectable, complex and ophthalmic, or TICO, strategy. During the second quarter, we submitted a Prior Approval Supplement to the FDA for our first injectable product, and we are working hard to target the launch of that product before the end of 2015."
Mr. Grenfell-Gardner concluded, "As of today, we have twenty-eight ANDAs pending with the FDA. Based on May 2015 IMS Health data, the addressable market for our pipeline of such twenty-eight ANDAs is estimated at $1.2 billion. We continue to see positive momentum in our correspondence with the FDA with regard to applications filed after October 1, 2014, or the third year after implementation of the Generic Drug User Fee Amendments of 2012. We are committed to responding effectively to the FDA's accelerated deadlines for applications currently under review, so we plan to submit up to a further fourteen ANDAs with the FDA this year, for a total of up to twenty new topical submissions in 2015."
The Company will hold a conference call today at 4:15 pm ET to discuss 2nd quarter 2015 results.
The Company invites you to listen to the call by dialing 1-888-346-3479. International participants should call 1-412-902-4260. Canadian participants should call 1-855-669-9657. Participants should ask to be joined into the IGI Laboratories, Inc. call.
This call is being webcast by MultiVu (a PR Newswire Company) and can be accessed in the Investor Relations Section of IGI's website at www.igilabs.com.
About IGI Laboratories, Inc.
IGI Laboratories is a specialty generic pharmaceutical company. Our mission is to be a leading player in the specialty generic prescription drug market.
Forward Looking Statements
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 included from time to time in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections in our most recent Annual Report on Form 10-K, as updated by 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 and the impact of global political, economic, business, competitive, market, regulatory and other factors; and our inability to complete successfully future product acquisitions. We assume no obligation to update any forward-looking statements or information, which speak as of their respective dates.
Non-GAAP Financial Measures
In addition to reporting financial information required in accordance with U.S. generally accepted accounting principles (GAAP), IGI is also presenting EBITDA and Adjusted EBITDA, which are non-GAAP financial measures. Since EBITDA and Adjusted EBITDA are non-GAAP financial measures, they should not be used in isolation or as a substitute for consolidated statements of operations and cash flow data prepared in accordance with GAAP. In addition, IGI's definition of Adjusted EBITDA may not be comparable to similarly titled non-GAAP financial measures reported by other companies.
Adjusted EBITDA, as defined by the Company, is calculated as follows:
Net income, plus:
Depreciation and amortization
Interest expense, net
Provision for income taxes
Amortization of acquisition costs related to Econazole purchase
Non-cash expenses, such as share-based compensation expense
Less change in the fair value of derivative liability
Adjusted Net Income, as defined by the Company, is calculated as follows:
Net income, plus:
Non-cash interest expense, net
Provision for income taxes
Amortization of acquisition costs related to Econazole purchase
Non-cash expenses, such as share-based compensation expense
Less change in the fair value of derivative liability
Adjusted Net Income Per Fully Diluted Share is equal to Adjusted Net Income divided by the actual or anticipated diluted share count for the applicable period.
The Company believes that EBITDA is a meaningful indicator, to both Company management and investors, of the past and expected ongoing operating performance of the Company. EBITDA is a commonly used and widely accepted measure of financial performance. Adjusted EBITDA is deemed by the Company to be a useful performance indicator because it includes an add back of non-cash and non-recurring operating expenses and change in the fair value of derivative liability which have little to no bearing on cash flows and may be subject to uncontrollable factors not reflective of the Company's true operational performance (i.e., fair value adjustments to the derivative liability).
While the Company uses Adjusted Net Income, EBITDA and Adjusted EBITDA in managing and analyzing its business and financial condition and believes these non-GAAP financial measures to be useful to investors in evaluating the Company's performance, it is open to certain shortcomings.
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