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 22, 2015
IGI LABORATORIES, INC.
(Exact name of registrant as specified in its charter)
Delaware | 001-08568 | 01-0355758 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
105
Lincoln Avenue
Buena, New Jersey 08310
(Address of principal executive offices and zip code)
Registrant’s telephone number, including area code: (856) 697-1441
_____________________________________________________________________________________
(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 (see General Instruction A.2. below):
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02. | Results of Operations and Financial Condition. |
On October 22, 2015, IGI Laboratories, Inc. (the “Company”) issued a press release announcing the Company’s earnings for the third quarter ended September 30, 2015 and certain other information. A copy of the press release is attached hereto as Exhibit 99.1.
The Company will conduct a conference call to review its financial results on October 22, 2015, at 4:15 p.m., Eastern Time.
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 8.01 | Other Events. |
On October 22, 2015, the Company issued a press release announcing (1) that the Company will be changing its name to “Teligent, Inc.” effective as of October 23, 2015, at 5:00 P.M. Eastern Daylight Time and (2) that the Company’s common stock, par value $0.01 per share, which was previously approved for listing on The NASDAQ Global Select Market, will be quoted under the trading symbol “TLGT” as of the first day of trading on such exchange on Monday, October 26, 2015. A copy of the press release is attached hereto as Exhibit 99.2, and incorporated herein by reference.
Neither the filing of the press release as an exhibit to this Current Report on Form 8-K nor the inclusion in the press release of a reference to the Company’s internet address shall, under any circumstances, be deemed to incorporate the information available at the Company’s internet address into this Current Report on Form 8-K. The information available at the Company’s internet address is not part of this Current Report on Form 8-K or any other report filed by it with the Securities and Exchange Commission.
Item 9.01 | Financial Statements and Exhibits. |
(d) | The following exhibits are filed with this Report: |
Exhibit No. |
Description | ||
99.1 99.2 |
Press release of IGI Laboratories, Inc., dated October 22, 2015. Press release of IGI Laboratories, Inc., dated October 22, 2015. | ||
SIGNATURES
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 thereunto duly authorized.
IGI LABORATORIES, INC. | |||
By: | /s/ Jenniffer Collins | ||
Name: | Jenniffer Collins | ||
Title: | Chief Financial Officer | ||
Date: October 22, 2015 |
Exhibit 99.1
News From:
Release Date: October 22, 2015
Contact: | Jenniffer Collins |
IGI Laboratories, Inc.
(856) 697-1441
www.igilabs.com
IGI LABORATORIES ANNOUNCES THIRD QUARTER 2015 RESULTS
Sales Grow 74% Over 2014 and 31% Over Second Quarter 2015
Submits Tenth ANDA in 2015
BUENA, NJ - (PR NEWSWIRE) – IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey-based specialty generic pharmaceutical company, announced its financial results for the third quarter ended September 30, 2015.
Third Quarter 2015 Highlights
· | Total revenues of $11.6 million in the third quarter of 2015, an increase of 74% over the same quarter in 2014 |
· | Total net revenues generated from the sale of IGI label generic topical pharmaceutical products for the third quarters of 2015 and 2014 of $8.7 million and $3.0 million, respectively |
· | Gross margin for the third quarter of 2015 equaled 52% as compared to 39% in the same period in 2014 |
· | IGI filed four Abbreviated New Drug Applications (ANDAs) in the third quarter of 2015 with the U.S. Food and Drug Administration (FDA) |
· | Operating income was $0.4 million in the third quarter of 2015 compared to an operating loss of $0.1 million in the same period in 2014 |
· | Adjusted EBITDA (as defined and reconciled to GAAP below) for the third quarter of 2015 and 2014 was $1.4 million and $0.1 million, respectively |
· | Adjusted net loss per fully diluted share (as defined and reconciled to GAAP below) for the third quarter of 2015 and 2014 was $0.00 and $0.00, respectively |
Full Year 2015 Financial Guidance
· | The Company now expects total revenue between $41.0 and $43.0 million for the year ended December 31, 2015. |
· | The Company anticipates gross margin of 49% to 50% for the year ended December 31, 2015. |
· | The Company intends to submit 15 to 17 ANDAs in total with the FDA for the full year 2015. In order to complete all of the development work required for the 2015 filings, the Company continues to expect to spend between $13.0 and $14.0 million in research and development by the end of 2015. |
· | As a result of the expected sequential increase in research and development costs in the fourth quarter of 2015, the Company intends for its operating margin to approach break even for the year ended December 31, 2015. |
IGI’s President and Chief Executive Officer, Jason Grenfell-Gardner, stated, “We are proud of our team’s continued ability to deliver and our financial results reflect solid execution this quarter. In addition, our announcements thus far in October have included the addition of Steve Richardson, our new Chief Scientific Officer, the acquisition of three commercialized injectable products in the US, for which we have already shipped orders in October, and the execution of an agreement to acquire Alveda Pharmaceuticals, Inc., a generic sterile injectable business in Canada. Today in the US market, we now market seven products in twelve presentations in the generic topical market, and another three products in seventeen presentations in the generic injectable market.
On the regulatory front, we have submitted ten ANDA submissions so far this year, including today’s submission,’’ Mr. Grenfell-Gardner continued. ‘’We also received the FDA’s final approval for our diclofenac sodium 1.5% topical solution in July, which we launched later that month. 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.”
Mr. Grenfell-Gardner continued, “As we have discussed, we are optimistic regarding the continued positive momentum that we are seeing in our interactions with the FDA, especially with regard to applications filed in Generic Drug User Fee Amendments (“GDUFA”) Year 3, which began on October 1, 2014. We believe that this increased rate of review is evidence that the implementation of the GDUFA of 2012 is working. In an attempt to shorten our potential review times, and ultimately obtain approvals more quickly, we have chosen to withdraw four of our applications from the FDA and resubmit them in 2016. Based on August IMS Health data, the addressable market for our pipeline of now twenty-eight ANDAs is estimated at $1.4 billion, excluding our four partnered submissions. Therefore, over 59% of the total addressable market in our pipeline relates to submissions filed in GDUFA Year 3 or later.
“As a result of the increased FDA activity around our filed pipeline, we determined it was necessary to make significant adjustments during this year to allocate the appropriate amount of our team’s time to responding effectively to the FDA’s accelerated deadlines for applications currently under review. While we have been expanding our team throughout the year, we believe that addressing the FDA’s accelerated response times had to take priority in the last few months. As we reallocate resources, we now plan to submit a further five to seven ANDAs with the FDA this year, for a total of fifteen to seventeen new topical submissions in 2015. The remaining planned 2015 submissions will be filed in the first half of 2016. We believe this is the right strategy to maximize the potential of our current and future pipeline.”
The Company will hold a conference call today at 4:15 pm ET to discuss third 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. Adjusted Net Income, EBITDA and Adjusted EBITDA do not take into account the impact of capital expenditures on either the liquidity or the financial performance of the Company and likewise omit share-based compensation expenses, which may vary over time and may represent a material portion of overall compensation expense. Due to the inherent limitations of Adjusted Net Income, EBITDA and Adjusted EBITDA, the Company's management utilizes comparable GAAP financial measures to evaluate the business in conjunction with Adjusted Net Income, EBITDA and Adjusted EBITDA and encourages investors to do likewise.
IGI LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share information)
September 30, 2015 | December 31, | |||||||
(Unaudited) | 2014* | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 145,699 | $ | 158,883 | ||||
Accounts receivable, net | 10,947 | 14,366 | ||||||
Inventories | 4,958 | 2,784 | ||||||
Prepaid expenses and other receivables | 1,348 | 1,185 | ||||||
Total current assets | 162,952 | 177,218 | ||||||
Property, plant and equipment, net | 7,117 | 3,262 | ||||||
Product acquisition costs, net | 12,031 | 10,604 | ||||||
Debt issuance costs, net | 4,575 | 5,132 | ||||||
Other | 479 | 862 | ||||||
Total assets | $ | 187,154 | $ | 197,078 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 3,013 | $ | 1,643 | ||||
Accrued expenses | 5,817 | 5,141 | ||||||
Payable for product acquisition costs | - | 6,000 | ||||||
Other current liabilities | 336 | 218 | ||||||
Total current liabilities | 9,166 | 13,002 | ||||||
Convertible 3.75% senior notes, net of debt discount (face of $143,750) | 105,239 | 100,311 | ||||||
Fair value of derivative liability - convertible 3.75% senior notes | - | 41,400 | ||||||
Note payable, bank | - | 3,160 | ||||||
Other long term liabilities | 200 | 71 | ||||||
Total liabilities | 114,605 | 157,944 | ||||||
Stockholders’ equity: | ||||||||
Series A Convertible Preferred stock, $0.01 par value, 100 shares | ||||||||
authorized; 0 shares issued and outstanding as of September 30, | ||||||||
2015 and December 31, 2014, respectively | - | - | ||||||
Series C Convertible Preferred stock, $0.01 par value, 1,550 shares | ||||||||
authorized; 0 shares issued and outstanding as of September 30, | ||||||||
2015 and December 31, 2014, respectively | - | - | ||||||
Common stock, $0.01 par value, 100,000,000 and 60,000,000 shares | ||||||||
authorized; 52,872,953 and 52,819,787 shares issued and outstanding | ||||||||
as of September 30, 2015 and December 31, 2014, respectively | 548 | 548 | ||||||
Additional paid-in capital | 98,544 | 78,172 | ||||||
Accumulated deficit | (26,543 | ) | (39,586 | ) | ||||
Total stockholders’ equity | 72,549 | 39,134 | ||||||
Total liabilities and stockholders' equity | $ | 187,154 | $ | 197,078 |
*Derived from the audited December 31, 2014 financial statements
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, | |||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||
Revenues: | ||||||||||||||||
Product sales, net | $ | 11,375 | $ | 6,005 | $ | 30,532 | $ | 18,525 | ||||||||
Research and development income | 237 | 635 | 475 | 1,385 | ||||||||||||
Licensing, royalty and other revenue | 3 | 28 | 172 | 95 | ||||||||||||
Total revenues | 11,615 | 6,668 | 31,179 | 20,005 | ||||||||||||
Costs and Expenses: | ||||||||||||||||
Cost of revenues | 5,538 | 4,036 | 15,808 | 11,603 | ||||||||||||
Selling, general and administrative expenses | 2,433 | 1,124 | 6,474 | 3,563 | ||||||||||||
Product development and research expenses | 3,253 | 1,652 | 9,319 | 5,045 | ||||||||||||
Total costs and expenses | 11,224 | 6,812 | 31,601 | 20,211 | ||||||||||||
Operating income (loss) | 391 | (144 | ) | (422 | ) | (206 | ) | |||||||||
Other Income (Expense): | ||||||||||||||||
Change in the fair value of derivative liability | - | - | 23,144 | - | ||||||||||||
Interest and other expense, net | (3,279 | ) | (58 | ) | (9,679 | ) | (162 | ) | ||||||||
Income (loss) before income tax expense | (2,888 | ) | (202 | ) | 13,043 | (368 | ) | |||||||||
Income tax expense | - | - | - | 12 | ||||||||||||
Net income (loss) | $ | (2,888 | ) | $ | (202 | ) | $ | 13,043 | $ | (380 | ) | |||||
Basic earnings (loss) per share | ($ | 0.05 | ) | $ | 0.00 | $ | 0.25 | ($ | 0.01 | ) | ||||||
Diluted earnings (loss) per share | ($ | 0.05 | ) | $ | 0.00 | ($ | 0.02 | ) | ($ | 0.01 | ) | |||||
Weighted average shares of common stock outstanding: | ||||||||||||||||
Basic | 52,869,529 | 52,457,938 | 52,857,624 | 48,811,328 | ||||||||||||
Diluted | 52,869,529 | 52,457,938 | 67,173,250 | 48,811,328 |
IGI LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For the nine months ended September 30, 2015 and 2014
(in thousands)
(Unaudited)
September 30, | September 30, | |||||||
2015 | 2014 | |||||||
Cash flows from operating activities: | ||||||||
Net income (loss) | $ | 13,043 | $ | (380 | ) | |||
Non-cash (income) expenses | (15,330 | ) | 1,244 | |||||
Changes in operating assets and liabilities | (1,922 | ) | (1,894 | ) | ||||
Net cash used in operating activities | (4,209 | ) | (1,030 | ) | ||||
Net cash used in investing activities | (5,751 | ) | (3,077 | ) | ||||
Net cash (used in) provided by financing activities | (3,254 | ) | 25,254 | |||||
Net (decrease) increase in cash and cash equivalents | (13,214 | ) | 21,147 | |||||
Cash and cash equivalents at beginning of period | 158,883 | 2,101 | ||||||
Cash and cash equivalents at end of period | $ | 145,669 | $ | 23,248 |
IGI LABORATORIES, INC. AND SUBSIDIARIES
RECONCILIATION OF NON-GAAP MEASURES
(in thousands)
Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||
Net income (loss) | $ | (2,888 | ) | $ | (202 | ) | $ | 13,043 | $ | (380 | ) | |||||
Depreciation and amortization expense | 164 | 131 | 454 | 367 | ||||||||||||
Interest expense, net | 1,377 | 50 | 4,147 | 138 | ||||||||||||
Non-cash interest expense | 1,902 | 8 | 5,532 | 24 | ||||||||||||
Provision for income taxes | - | - | - | 12 | ||||||||||||
EBITDA | 555 | (13 | ) | 23,176 | 161 | |||||||||||
Amortization of product acquisition costs | 30 | 30 | 90 | 90 | ||||||||||||
Stock-based compensation expense | 802 | 130 | 1,708 | 649 | ||||||||||||
Change in the fair value of derivative liability | - | - | (23,144 | ) | - | |||||||||||
Adjusted EBITDA | $ | 1,387 | $ | 147 | $ | 1,830 | $ | 900 |
IGI LABORATORIES, INC. AND SUBSIDIARIES
RECONCILIATION OF NON-GAAP ADJUSTED NET INCOME
(in thousands, except share and per share information)
Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||
Net income (loss) | $ | (2,888 | ) | $ | (202 | ) | $ | 13,043 | $ | (380 | ) | |||||
Non-cash interest expense | 1,902 | 8 | 5,532 | 24 | ||||||||||||
Provision for income taxes | - | - | - | 12 | ||||||||||||
Amortization of product acquisition costs | 30 | 30 | 90 | 90 | ||||||||||||
Non-cash stock-based compensation expense | 802 | 130 | 1,708 | 649 | ||||||||||||
Change in the fair value of derivative liability | - | - | (23,144 | ) | - | |||||||||||
Adjusted net Income | $ | (154 | ) | $ | (34 | ) | $ | (2,771 | ) | $ | 395 | |||||
Non- GAAP Adjusted net income (loss) per diluted share | $ | (0.00 | ) | $ | (0.00 | ) | $ | (0.04 | ) | $ | 0.01 | |||||
Weighted average shares of common stock outstanding: | ||||||||||||||||
Diluted | 52,869,529 | 52,457,938 | 67,173,250 | 48,811,328 |
IGI LABORATORIES, INC. AND SUBSIDIARIES
GROSS TO NET CALCULATION
(in thousands)
Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||
Gross IGI product sales | $ | 23,167 | $ | 14,823 | $ | 73,347 | $ | 25,618 | ||||||||
Reduction to gross product sales: | ||||||||||||||||
Chargebacks and billbacks | 9,072 | 10,365 | 37,160 | 13,832 | ||||||||||||
Sales discounts and other allowances | 5,381 | 1,445 | 12,703 | 2,446 | ||||||||||||
Total reduction to gross product sales | 14,453 | 11,810 | 49,863 | 16,278 | ||||||||||||
IGI product sales, net | 8,714 | 3,013 | 23,484 | 9,340 | ||||||||||||
Contract manufacturing product sales | 2,661 | 2,992 | 7,048 | 9,185 | ||||||||||||
Total product sales, net | $ | 11,375 | $ | 6,005 | $ | 30,532 | $ | 18,525 |
Exhibit 99.2
News From:
Release Date: October 22, 2015
Contact: | Jenniffer Collins |
IGI Laboratories, Inc. | |
(856) 697-1441 | |
www.igilabs.com |
IGI LABORATORIES, INC. ANNOUNCES NAME CHANGE TO TELIGENT, INC.
New Name and Corporate Identity Reflect the Company’s Ongoing Transformation
BUENA, NJ - (PR NEWSWIRE) – IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey-based specialty generic pharmaceutical company, announced that it will adopt Teligent, Inc. as its new name and will begin trading under a new symbol – TLGT – after ringing the NASDAQ Opening Bell on October 26, 2015.
‘’Our new name captures the energy and passion that our people feel about our future,’’ said Jason Grenfell-Gardner, the Company’s President and Chief Executive Officer. ‘’We are proud of what we have accomplished so far in our Company’s transformation, and our people are energized by the opportunities that we see ahead of us.
‘’There are three pillars that shape the kind of company that we are building. First, we are driven by robust science. Second, we accept no middle ground when it comes to product quality. Finally, we believe in fostering a career of craftsmanship, where our people can become experts in their trade. Our new brand identity evolved from these three pillars, and they will continue to shape our future.’’
The icon in the new logo includes a distinctive spark that speaks to the unifying energy of the Company’s culture. The spark reflects the dynamic, yet human and engaging characteristic that is shared and valued by employees. As part of the name change, the Company is launching a new website at www.Teligent.com on October 23, 2015.
The Company continues to trade under ticker symbol IG on NYSE MKT until market close on October 23, 2015. Trading on NASDAQ under the Teligent name and ticker symbol TLGT will begin at market open on October 26, 2015.
About IGI Laboratories, Inc. (Soon to be Teligent, Inc. as of 5:00 PM EDT on October 23, 2015)
IGI Laboratories, Inc., soon to be Teligent, Inc., 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.