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x
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ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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58-2301143
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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210 Main Street West
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Baudette, Minnesota
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56623
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(Address of principal executive offices)
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(Zip Code)
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Title of each class
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Name of each exchange on which registered
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Common Stock, par value $0.0001 per share
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The NASDAQ Global Market
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Large accelerated filer
¨
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Accelerated filer
¨
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Non-accelerated filer
¨
(Do not check if a smaller reporting company) |
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Smaller reporting company
x
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Page
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PART I
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Item 1.
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Business
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3
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Item 1A.
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Risk Factors
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15
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Item 1B.
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Unresolved Staff Comments
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32
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Item 2.
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Properties
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32
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Item 3.
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Legal Proceedings
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33
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Item 4.
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Mine Safety Disclosures
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34
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PART II
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Item 5.
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Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
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35
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Item 6.
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Selected Consolidated Financial Data
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35
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Item 7.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations
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36
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Item 7A.
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Quantitative and Qualitative Disclosures About Market Risk
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49
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Item 8.
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Consolidated Financial Statements and Supplementary Data
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50
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Item 9.
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Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
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81
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Item 9A.
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Controls and Procedures
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81
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Item 9B.
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Other Information
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82
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PART III
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Item 10.
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Directors, Executive Officers and Corporate Governance
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83
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Item 11.
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Executive Compensation
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83
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Item 12.
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Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
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83
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Item 13.
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Certain Relationships and Related Transactions, and Director Independence
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83
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Item 14.
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Principal Accountant Fees and Services
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84
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PART IV
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Item 15.
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Exhibits and Financial Statement Schedules
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85
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Signatures
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86
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1 | ||
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2 | ||
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3 | ||
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·
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Formulation Complexity.
The Company's development and manufacturing capabilities enable it to manufacture pharmaceuticals that are difficult to produce, including highly potent, extended release, combination, and low dosage products. This ability to manufacture a variety of complex products is a competitive strength that the Company intends to leverage in selecting products to develop or manufacture.
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·
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Patent Status.
The Company seeks to develop products whose branded bioequivalents do not have long-term patent protection or existing patent challenges.
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·
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Market Size.
When determining whether to develop or acquire an individual product, management reviews the current and expected market size for that product at launch, as well as forecasted price erosion upon conversion from branded to generic pricing. The Company endeavors to manufacture products with sufficient market size to enable the Company to enter the market with a strong likelihood of being able to price its product both competitively and at a profit.
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·
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Profit Potential.
Management researches the availability and cost of active pharmaceutical ingredients along with anticipated market share in determining which products to develop or acquire. In determining the potential profit of a product, management forecasts the Company’s anticipated market share, pricing, which includes expected price erosion caused by competition from other generic manufacturers, and the estimated cost to manufacture the products.
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·
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Manufacturing.
The Company generally seeks to develop and manufacture products at its own manufacturing plants in order to maximize the capacity and utilization of its facilities, to ensure quality control in its products, and to maximize profit potential.
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·
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Competition.
When determining whether to develop or acquire an individual product, management researches the existing and expected market share of generic competitors. The Company seeks to develop products for which it can obtain a large market share, and may decline to develop a product if management anticipates that many generic competitors will be entering that product’s market. The Company’s highly specialized manufacturing facilities provide a means of entering niche markets, such as hormone therapies, in which fewer generic companies would be able to compete.
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·
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Increased prescription product sales through market share gains on established products.
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·
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Acquired the New Drug Application (“NDA”) for and began marketing Reglan
®
.
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·
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Developed two new contract manufacturing customer relationships.
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·
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Established two external product development partnerships to bolster the internal pipeline.
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·
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Filed five Abbreviated New Drug Applications (“ANDAs”) and developed a pipeline of seven additional ANDAs.
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·
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Entered into a contract to purchase the ANDAs for 31 previously marketed generic drug products, including 20 solid-oral immediate release products, four extended release products and seven liquid products for $12.5 million. This asset acquisition will help the Company expand and diversify its product lines over the next few years, help increase revenue, and reduce the Company’s percentage of revenue derived from sales of unapproved products.
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4 | ||
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Generic Products
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Branded Products
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Esterified Estrogen with Methyltestosterone Tablets
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Cortenema
®
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Fluvoxamine Maleate Tablets
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Reglan
®
Tablets
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Hydrocortisone Enema
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Metoclopramide Syrup
Opium Tincture
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5 | ||
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·
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Hormone and steroid products are a core competency based on the Company’s manufacturing and product development teams' long history of manufacturing these types of products; and |
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·
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The aging baby boom population, of which women represent a majority, is expected to support continued growth in the HT market. |
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·
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Free-up internal resources to focus on sales and marketing as well as research and development;
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·
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Employ internal capacity to manufacture higher volume or more critical products; and
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·
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Utilize the Company’s specialized equipment and expertise.
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6 | ||
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7 | ||
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8 | ||
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9 | ||
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10 | ||
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11 | ||
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·
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Wholesalers.
The Company has contracts with four major wholesalers in the United States: Cardinal, McKesson, AmerisourceBergen, and Morris Dickson, as well as access to their respective retail source programs.
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·
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Retail Market Chains.
The Company conducts business with four major retail chains in the United States: Walgreens, CVS, RiteAid, and Wal-Mart.
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·
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Distributors and Mail Order Pharmacies.
The Company has contracts with several major distributors and mail order pharmacies in the United States, including Anda, ExpressScripts, and Omnicare.
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· | Hospital Market. The Company has contracts with group purchasing organizations in the United States, such as Premiere, MedAssets, Minnesota Multi-State, and the Federal Supply Schedule (“FSS”). |
12 | ||
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13 | ||
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14 | ||
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Item 1A.
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Risk Factors
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15 | ||
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16 | ||
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17 | ||
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·
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greater financial resources;
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·
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proprietary processes or delivery systems;
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·
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larger research and development and marketing staffs;
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·
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larger production capabilities;
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·
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more products; or
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·
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more experience in developing new drugs.
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18 | ||
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·
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the availability of alternative products from the Company’s competitors;
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·
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the price of the Company's products relative to that of the Company's competitors;
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·
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the effectiveness of the Company’s marketing relative to that of the Company’s competitors;
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·
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the timing of the Company's market entry;
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·
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the ability to market the Company's products effectively to the retail level; and
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·
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the acceptance of the Company's products by government and private formularies.
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19 | ||
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·
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diversion of management time and focus from operating the Company's business to addressing acquisition and/or product integration challenges;
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·
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coordination of research and development and sales and marketing functions;
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·
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retention of key employees from the acquired company;
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·
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integration of the acquired company’s accounting, management information, human resources and other administrative systems;
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·
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the need to implement or improve controls, procedures, and policies at a business that prior to the acquisition may have lacked effective controls, procedures and policies;
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·
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liability for activities of the acquired company and/or products before the acquisition, including patent infringement claims, violations of laws, commercial disputes, tax liabilities and other known and unknown liabilities;
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·
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unanticipated write-offs or charges; and
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·
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litigation or other claims in connection with the acquired company or product, including claims from product users, former stockholders or other third parties.
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20 | ||
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·
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entering into agreements whereby other generic companies will begin to market an authorized generic, a generic equivalent of a branded product, at the same time generic competition initially enters the market;
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·
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launching a generic version of their own branded product at the same time generic competition initially enters the market;
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·
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filing citizen's petitions with the FDA or other regulatory bodies, including timing the filings so as to thwart generic competition by causing delays of the Company’s product approvals;
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·
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seeking to establish regulatory and legal obstacles that would make it more difficult to demonstrate bioequivalence or meet other approval requirements;
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·
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initiating legislative and regulatory efforts to limit the substitution of generic versions of branded pharmaceuticals;
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·
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filing suits for patent infringement that may delay regulatory approval of generic products;
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21 | ||
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·
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introducing "next-generation" products prior to the expiration of market exclusivity for the reference product, which often materially reduces the demand for the first generic product for which the Company seeks regulatory approval;
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·
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obtaining extensions of market exclusivity by conducting clinical trials of branded drugs in pediatric populations or by other potential methods;
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·
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persuading regulatory bodies to withdraw the approval of branded name drugs for which the patents are about to expire, thus allowing the branded name company to obtain new patented products serving as substitutes for the products withdrawn; and
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·
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seeking to obtain new patents on drugs for which patent protection is about to expire.
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22 | ||
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23 | ||
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24 | ||
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25 | ||
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26 | ||
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27 | ||
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28 | ||
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·
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general stock market and general economic conditions in the United States and abroad, even if not directly related to the Company or its business;
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·
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any inability to manufacture EEMT, whether due to FDA determinations or otherwise;
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·
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disruptions in the supply of API and other ingredients used in the Company’s current and planned products;
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·
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actual or anticipated governmental agency actions, including in particular decisions or actions by the FDA or FDA advisory committee panels with respect to the Company’s current products, products in development, or its competitors’ products;
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·
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changes in anticipated or actual timing of the Company’s product development programs;
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·
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competition in the Company’s industry;
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·
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the Company entering into new strategic partnering arrangements or termination of existing strategic partnering arrangements;
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·
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public concern as to the safety or efficacy of the Company’s products;
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·
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the Company’s need and ability to obtain additional financing;
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29 | ||
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·
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changes in laws or regulations applicable to the Company’s products or business;
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·
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period-to-period fluctuations in the Company’s financial results;
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·
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changes in key management;
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·
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sales of shares of the Company's common stock by the Company or its stockholders;
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·
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failure of securities analysts to initiate and maintain coverage of the Company and, with respect to any analyst coverage, the Company's failure to meet analyst estimates or the expectations of investors;
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·
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announcements by the Company or its competitors of new products or services;
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·
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the public’s reaction to the Company's press releases, other public announcements and filings with the SEC;
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·
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rumors and market speculation involving the Company or other companies in the Company’s business;
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·
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actual or anticipated changes in the Company's operating results or fluctuations in its operating results;
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·
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actual or anticipated developments in the Company's business, its competitors’ businesses or the competitive landscape generally;
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·
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litigation involving the Company, its industry or both, or investigations by regulators into the Company's operations or those of its competitors;
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·
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announced or completed acquisitions of businesses or products by the Company or its competitors;
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·
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new laws or regulations or new interpretations of existing laws or regulations applicable to the Company's business;
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·
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changes in accounting standards, policies, guidelines, interpretations or principles; and
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·
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slow or negative growth of the Company's products or markets.
|
30 | ||
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31 | ||
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·
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authorizing the issuance of “blank check” preferred shares that could be issued by the Company’s board of directors to increase the number of outstanding shares and thwart a takeover attempt;
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·
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prohibiting cumulative voting in the election of directors, which would otherwise allow less than a majority of stockholders to elect director candidates;
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·
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advance notice provisions in connection with stockholder proposals and director nominations that may prevent or hinder any attempt by the Company’s stockholders to bring business to be considered by its stockholders at a meeting or replace its board of directors; and
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·
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as a Delaware corporation, the Company is also subject to provisions of Delaware law, including Section 203 of the Delaware General Corporation law, which prevents certain stockholders holding more than 15% of the Company's outstanding common stock from engaging in certain business combinations without approval of the holders of at least two-thirds of its outstanding common stock not held by such 15% or greater stockholder.
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32 | ||
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33 | ||
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34 | ||
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Common Stock Price
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||||||||||
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2013
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2012
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||||||||
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High
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Low
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High
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Low
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||||
First Quarter
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$
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9.48
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$
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6.60
|
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$
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44.28
|
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$
|
15.84
|
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Second Quarter
|
|
$
|
8.64
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$
|
4.80
|
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$
|
27.36
|
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$
|
12.00
|
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Third Quarter
|
|
$
|
9.94
|
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$
|
5.46
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$
|
15.72
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$
|
7.26
|
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Fourth Quarter
|
|
$
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23.00
|
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$
|
9.75
|
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$
|
11.82
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$
|
6.48
|
|
35 | ||
|
36 | ||
|
|
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Years Ended December 31,
|
|
|||
|
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2013
|
|
|
2012
|
|
Net revenues
|
|
100.0
|
%
|
|
100.0
|
%
|
Operating expenses
|
|
|
|
|
|
|
Cost of sales (exclusive of depreciation and amortization)
|
|
33.2
|
%
|
|
45.0
|
%
|
Research and development
|
|
5.7
|
%
|
|
5.7
|
%
|
Selling, general and administrative
|
|
54.5
|
%
|
|
46.7
|
%
|
Depreciation and amortization
|
|
3.6
|
%
|
|
2.8
|
%
|
Operating income (loss) from continuing operations
|
|
3.0
|
%
|
|
(0.2)
|
%
|
|
|
|
|
|
|
|
Interest expense
|
|
1.6
|
%
|
|
6.5
|
%
|
Other expense
|
|
1.0
|
%
|
|
1.2
|
%
|
Net income (loss) from continuing operations
|
|
0.4
|
%
|
|
(7.7)
|
%
|
Gain on discontinued operation
|
|
0.6
|
%
|
|
0.3
|
%
|
Net income (loss)
|
|
1.0
|
%
|
|
(7.4)
|
%
|
|
Years Ended December 31,
|
|
||||
(in thousands)
|
2013
|
|
2012
|
|
||
Net revenues
|
$
|
30,082
|
|
$
|
20,371
|
|
|
|
|
|
|
|
|
Operating expenses
|
|
|
|
|
|
|
Cost of sales (exclusive of depreciation and amortization)
|
|
9,974
|
|
|
9,167
|
|
Research and development
|
|
1,712
|
|
|
1,158
|
|
Selling, general and administrative
|
|
16,388
|
|
|
9,521
|
|
Depreciation and amortization
|
|
1,110
|
|
|
567
|
|
Operating income (loss) from continuing operations
|
|
898
|
|
|
(42)
|
|
|
|
|
|
|
|
|
Interest expense
|
|
467
|
|
|
1,327
|
|
Other expense
|
|
305
|
|
|
241
|
|
Net Income/(Loss) from Continuing Operations
|
|
|
|
|
|
|
Before (Provision) Benefit for Income Taxes
|
|
126
|
|
|
(1,610)
|
|
|
|
|
|
|
|
|
(Provision) benefit for income taxes
|
|
(20)
|
|
|
36
|
|
Net income (loss) from continuing operations
|
|
106
|
|
|
(1,574)
|
|
|
|
|
|
|
|
|
Gain on discontinued operation
|
|
195
|
|
|
68
|
|
Net income (loss)
|
$
|
301
|
|
$
|
(1,506)
|
|
37 | ||
|
(in thousands)
|
|
Years Ended December 31,
|
|
|
|
|
|
|
||||
|
|
2013
|
|
2012
|
|
Change
|
|
%
Change |
|
|||
Generic pharmaceutical products
|
|
$
|
19,281
|
|
$
|
10,157
|
|
$
|
9,124
|
|
89.8
|
%
|
Branded pharmaceutical products
|
|
|
3,370
|
|
|
1,829
|
|
|
1,541
|
|
84.3
|
%
|
Contract manufacturing
|
|
|
6,018
|
|
|
7,557
|
|
|
(1,539)
|
|
(20.4)
|
%
|
Contract services and other income
|
|
|
1,413
|
|
|
828
|
|
|
585
|
|
70.7
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues
|
|
$
|
30,082
|
|
$
|
20,371
|
|
$
|
9,711
|
|
47.7
|
%
|
|
·
|
Net revenues for generic pharmaceutical products were $19.3 million in the year ended December 31, 2013, an increase of 89.8% compared to $10.2 million for 2012. A
primary reason for the $9.1 million increase was an $8.1 million increase in revenue related to Esterified Estrogen with Methyltestosterone tablets (“EEMT”), which was the result of increases in both market share and prices per bottle, due to a significant decrease in competition, beginning in the third quarter of 2013, which the Company cannot be certain will continue. For the year ended December 31, 2013, EEMT comprised 33% of the Company’s net sales, a substantial increase over the prior year wherein EEMT comprised only 9% of the Company’s net sales. In the third quarter of 2013, a significant competitor stopped producing EEMT, which led to a material increase in the Company’s market share for the product and enabled the Company to significantly increase the price it charges for the product.
Market share gains on Opium Tincture and Fluvoxamine Maleate tablets also contributed to increased generic product revenues.
|
|
|
|
|
|
As discussed further under Item 1. Business Government Regulations Unapproved Products, the Company markets EEMT and Opium Tincture without FDA-approved NDAs or ANDAs. The FDA's policy with respect to the continued marketing of unapproved products appears in the FDA's September 2011 Compliance Policy Guide Sec. 440.100 titled "Marketed New Drugs without Approved NDAs or ANDAs." Under this policy, the FDA has stated that it will follow a risk-based approach with regard to enforcement against marketing of unapproved products. The FDA evaluates whether to initiate enforcement action on a case-by-case basis, but gives higher priority to enforcement action against products in certain categories, such as those with potential safety risks or that lack evidence of effectiveness. While the Company believes that, so long as it complies with applicable manufacturing and labeling standards, the FDA will not take action against it under the current enforcement policy, it can offer no assurances that the FDA will continue this policy or not take a contrary position with any individual product or group of products. The Company's combined net revenues for these products for the
years ended December 31, 2013 and 2012 were $14.6 million and $6.0 million, respectively.
|
38 | ||
|
|
·
|
Net revenues for branded pharmaceutical products were $3.4 million in the year ended December 31, 2013, an increase of 84.3% compared to $1.8 million for the same period in 2012.
The primary reason for the increase was higher unit sales of Reglan
®
tablets. Higher unit sales of Cortenema
®
contributed to the increase to a lesser extent.
|
|
|
|
|
·
|
Contract manufacturing revenues were $6.0 million for the year ended December 31 2013, a decrease of 20.4% from $7.6 million for 2012, due to decreased orders from contract manufacturing customers during the 2013 period.
One group of products that the Company manufactures on behalf of a contract customer is marketed by that customer without an FDA-approved NDA. If the FDA took enforcement action against such customer, the customer may be required to seek FDA approval for the group of products or withdraw them from the market. The Company's contract manufacturing revenue for the group of unapproved products for the years ended December 31, 2013 and 2012 was $2.0 million and $1.4 million, respectively.
|
|
|
|
|
·
|
Contract services and other income were $1.4 million for the year ended December 31, 2013, an increase of 70.7% from approximately $0.8 million for 2012, due to a $0.5 million non-recurring payment from Teva in relation to the Teva license agreement acquired in the Merger. The Company receives royalties on the net sales of a group of contract-manufactured products, which are marketed by the contract customer without an FDA-approved NDA. If the FDA took enforcement action against such customer, the customer may be required to seek FDA approval for the group of products or withdraw them from the market. The Company’s royalties on the net sales of these unapproved products for the years ended December 31, 2013 and 2012 were $330 thousand and $284 thousand, respectively.
|
(in thousands)
|
|
Years Ended December 31,
|
|
|
|
|
|
|
|
||||
|
|
2013
|
|
2012
|
|
Change
|
|
%
Change |
|
||||
Cost of sales (excl. depreciation and amortization)
|
|
$
|
9,974
|
|
$
|
9,167
|
|
$
|
807
|
|
|
8.8
|
%
|
39 | ||
|
(in thousands)
|
|
Years Ended December 31,
|
|
|
|
|
|
|
|
||||
|
|
2013
|
|
2012
|
|
Change
|
|
%
Change |
|
||||
Research and development
|
|
$
|
1,712
|
|
$
|
1,158
|
|
$
|
554
|
|
|
47.8
|
%
|
Selling, general and administrative
|
|
|
16,388
|
|
|
9,521
|
|
|
6,867
|
|
|
72.1
|
%
|
Depreciation and amortization
|
|
|
1,110
|
|
|
567
|
|
|
543
|
|
|
95.8
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other operating expenses
|
|
$
|
19,210
|
|
$
|
11,246
|
|
$
|
7,964
|
|
|
70.8
|
%
|
|
·
|
Research and development expenses increased from $1.2 million in 2012 to $1.7 million in 2013, due to increased expenses incurred with respect to the RiconPharma and Sofgen collaborative arrangements. The Company anticipates that research and development costs will continue to increase based on the Company’s strategy to expand its product portfolio.
|
|
|
|
|
·
|
Selling, general and administrative expenses increased from $9.5 million in 2012 to $16.4 million in 2013, primarily as a result of $6.2 million of expenses incurred relating to the Merger, including $4.5 million of non-cash transaction bonuses paid to the Company’s executives upon completion of the Merger. In addition, one-time bonuses paid to certain officers after completion of the merger and increases in personnel contributed to the increase in expense.
|
|
|
|
|
·
|
Depreciation and amortization increased from $0.6 million in 2012 to $1.1 million in 2013, an increase of 95.8%, due to amortization of the Teva license acquired in the Merger. The Teva license is being amortized over its estimated useful life of 11 years.
|
40 | ||
|
(in thousands)
|
|
Years Ended December 31,
|
|
|
|
|
|
|
|
||||
|
|
2013
|
|
2012
|
|
Change
|
|
% Change
|
|
||||
Interest expense
|
|
$
|
467
|
|
$
|
1,327
|
|
$
|
(860)
|
|
|
(64.8)
|
%
|
Other expense
|
|
|
305
|
|
|
241
|
|
|
64
|
|
|
26.4
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other expenses
|
|
$
|
772
|
|
$
|
1,568
|
|
$
|
(796)
|
|
|
(50.8)
|
%
|
|
·
|
Interest expense decreased from $1.3 million to $0.5 million. In June 2012, all of ANIP’s subordinated debt was converted to Series D convertible preferred stock. In addition, the Company paid down its revolving line of credit in the second quarter of 2013, in connection with the Merger. The resulting reductions from both the subordinated debt conversion and repayment of the revolving line of credit were partially offset by an early termination fee and accelerated amortization of deferred loan costs incurred upon repayment of the line of credit.
|
|
|
|
|
·
|
Other expense increased from $0.2 million to $0.3 million as a result of payments totaling $0.4 million to certain of the Company’s investors for monitoring and advisory fees, partially offset by other income from the third quarter resulting from the settling of several aged liabilities.
|
(in thousands)
|
|
Years Ended December 31,
|
|
|
|
|
|
|
|
||||
|
|
2013
|
|
2012
|
|
Change
|
|
% Change
|
|
||||
Gain on discontinued operation, net of tax
|
|
$
|
195
|
|
$
|
68
|
|
$
|
127
|
|
|
187.6
|
%
|
41 | ||
|
(in thousands)
|
|
December 31,
|
|
||||
|
|
2013
|
|
2012
|
|
||
Cash and cash equivalents
|
|
$
|
11,105
|
|
$
|
11
|
|
Accounts receivable, net
|
|
|
12,513
|
|
|
5,432
|
|
Inventories
|
|
|
3,518
|
|
|
2,810
|
|
Prepaid expenses
|
|
|
580
|
|
|
313
|
|
Total current assets
|
|
$
|
27,716
|
|
$
|
8,566
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
1,429
|
|
$
|
1,994
|
|
Accrued expenses
|
|
|
1,326
|
|
|
927
|
|
Returned goods reserve
|
|
|
736
|
|
|
411
|
|
Deferred revenue
|
|
|
47
|
|
|
315
|
|
Borrowing under line of credit
|
|
|
-
|
|
|
4,065
|
|
Total current liabilities
|
|
$
|
3,538
|
|
$
|
7,712
|
|
|
·
|
proportions of net revenues comprised of contract manufacturing and sales of the Company’s generic and branded products;
|
|
·
|
pricing and payment terms with customers;
|
42 | ||
|
|
·
|
costs of raw materials and payment terms with suppliers;
|
|
·
|
capital expenditures and equipment purchases to support product launches; and
|
|
·
|
business and product acquisitions.
|
43 | ||
|
(in thousands)
|
|
Years ended December 31,
|
|
||||
|
|
2013
|
|
2012
|
|
||
Operating Activities
|
|
$
|
(5,484)
|
|
$
|
(137)
|
|
Investing Activities
|
|
$
|
20,267
|
|
$
|
(292)
|
|
Financing Activities
|
|
$
|
(3,689)
|
|
$
|
440
|
|
44 | ||
|
45 | ||
|
46 | ||
|
47 | ||
|
48 | ||
|
49 | ||
|
50 | ||
|
|
|
December 31,
2013 |
|
December 31,
2012 |
|
||
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Assets
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
11,105
|
|
$
|
11
|
|
Accounts receivable, net of $5,104 and $6,124 of adjustments for chargebacks
and other allowances at December 31, 2013 and 2012, respectively |
|
|
12,513
|
|
|
5,432
|
|
Inventories, net
|
|
|
3,518
|
|
|
2,810
|
|
Prepaid expenses
|
|
|
580
|
|
|
313
|
|
Total Current Assets
|
|
|
27,716
|
|
|
8,566
|
|
|
|
|
|
|
|
|
|
Property and Equipment, net
|
|
|
4,537
|
|
|
4,880
|
|
Deferred loan costs, net
|
|
|
-
|
|
|
217
|
|
Intangible assets, net
|
|
|
10,409
|
|
|
85
|
|
Goodwill
|
|
|
1,838
|
|
|
-
|
|
|
|
|
|
|
|
|
|
Total Assets
|
|
$
|
44,500
|
|
$
|
13,748
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity/(Deficit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Liabilities
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
1,429
|
|
$
|
1,994
|
|
Accrued expenses
|
|
|
1,326
|
|
|
927
|
|
Returned goods reserve
|
|
|
736
|
|
|
411
|
|
Deferred revenue
|
|
|
47
|
|
|
315
|
|
Borrowings under line of credit
|
|
|
-
|
|
|
4,065
|
|
Total Current Liabilities
|
|
|
3,538
|
|
|
7,712
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies (Note 14)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Redeemable Convertible Preferred Stock (Note 9)
|
|
|
-
|
|
|
48,751
|
|
|
|
|
|
|
|
|
|
Stockholders' Equity/(Deficit)
|
|
|
|
|
|
|
|
Common Stock, $0.0001 par value, 33,333,334 shares authorized; 9,629,174 shares
issued and 9,619,941 shares outstanding at December 31, 2013; 4,070,373 shares issued and outstanding at December 31, 2012 |
|
|
1
|
|
|
-
|
|
Class C Special Stock, $0.0001 par value, 781,281 shares authorized; 10,868 shares
issued and outstanding at December 31, 2013 and 2012, respectively |
|
|
-
|
|
|
-
|
|
Preferred Stock, $0.0001 par value, 1,666,667 shares authorized; 0 shares issued and
outstanding at December 31, 2013 and 2012, respectively |
|
|
-
|
|
|
-
|
|
Treasury stock, 9,233 shares of common stock, at cost, at December 31, 2013
|
|
|
(68)
|
|
|
-
|
|
Additional paid-in capital
|
|
|
89,501
|
|
|
1,083
|
|
Accumulated deficit
|
|
|
(48,472)
|
|
|
(43,798)
|
|
Total Stockholders' Equity/(Deficit)
|
|
|
40,962
|
|
|
(42,715)
|
|
|
|
|
|
|
|
|
|
Total Liabilities and Stockholders' Equity/(Deficit)
|
|
$
|
44,500
|
|
$
|
13,748
|
|
51 | ||
|
|
|
Years ended December 31,
|
|
||||
|
|
2013
|
|
2012
|
|
||
|
|
|
|
|
|
|
|
Net Revenues
|
|
$
|
30,082
|
|
$
|
20,371
|
|
|
|
|
|
|
|
|
|
Operating Expenses
|
|
|
|
|
|
|
|
Cost of sales (excluding depreciation and amortization)
|
|
|
9,974
|
|
|
9,167
|
|
Research and development
|
|
|
1,712
|
|
|
1,158
|
|
Selling, general and administrative
|
|
|
16,388
|
|
|
9,521
|
|
Depreciation and amortization
|
|
|
1,110
|
|
|
567
|
|
|
|
|
|
|
|
|
|
Total Operating Expenses
|
|
|
29,184
|
|
|
20,413
|
|
|
|
|
|
|
|
|
|
Operating Income/(Loss) from Continuing Operations
|
|
|
898
|
|
|
(42)
|
|
|
|
|
|
|
|
|
|
Other Expense
|
|
|
|
|
|
|
|
Interest expense
|
|
|
(467)
|
|
|
(1,327)
|
|
Other expense
|
|
|
(305)
|
|
|
(241)
|
|
|
|
|
|
|
|
|
|
Net Income/(Loss) from Continuing Operations
|
|
|
|
|
|
|
|
Before Benefit for Income Taxes
|
|
|
126
|
|
|
(1,610)
|
|
|
|
|
|
|
|
|
|
(Provision)/Benefit for income taxes
|
|
|
(20)
|
|
|
36
|
|
|
|
|
|
|
|
|
|
Net Income/(Loss) from Continuing Operations
|
|
|
106
|
|
|
(1,574)
|
|
|
|
|
|
|
|
|
|
Discontinued Operation
|
|
|
|
|
|
|
|
Gain on discontinued operation, net of provision (benefit) for income taxes
|
|
|
195
|
|
|
68
|
|
|
|
|
|
|
|
|
|
Net Income/(Loss)
|
|
$
|
301
|
|
$
|
(1,506)
|
|
|
|
|
|
|
|
|
|
Computation of Income/(Loss) from Continuing Operations
Attributable to Common Stockholders: |
|
|
|
|
|
|
|
Net Income/(Loss) from Continuing Operations
|
|
$
|
106
|
|
$
|
(1,574)
|
|
Preferred stock dividends
|
|
|
(4,975)
|
|
|
(6,922)
|
|
(Loss) from Continuing Operations
|
|
|
|
|
|
|
|
Attributable to Common Stockholders
|
|
$
|
(4,869)
|
|
$
|
(8,496)
|
|
|
|
|
|
|
|
|
|
Basic and Diluted Income/(Loss) Per Share:
|
|
|
|
|
|
|
|
Continuing operations
|
|
$
|
(0.96)
|
|
|
N/A
|
(1)
|
Discontinued operation
|
|
|
0.04
|
|
|
N/A
|
(1)
|
Basic and Diluted Income/(Loss) Per Share
|
|
$
|
(0.92)
|
|
|
N/A
|
(1)
|
|
|
|
|
|
|
|
|
Basic and Diluted Weighted-Average Shares Outstanding
|
|
|
5,071
|
|
|
N/A
|
(1)
|
52 | ||
|
|
|
Common
|
|
Common
|
|
Class C
|
|
Additional
|
|
Treasury
|
|
|
|
|
|
|
|
|||||||
|
|
Stock
|
|
Stock
|
|
Special
|
|
Paid-in
|
|
Stock
|
|
Treasury
|
|
Accumulated
|
|
|
|
|||||||
|
|
Par Value
|
|
Shares
|
|
Stock
|
|
Capital
|
|
Shares
|
|
Stock
|
|
Deficit
|
|
Total
|
|
|||||||
Balance, December 31, 2011
|
|
$
|
-
|
|
3,045
|
|
$
|
-
|
|
$
|
1,086
|
|
|
-
|
|
$
|
-
|
|
$
|
(35,370)
|
|
$
|
(34,284)
|
|
Issuance of Common Stock upon Cashless Warrant Exercise
|
|
|
2
|
|
22
|
|
|
-
|
|
|
(2)
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
Issuance of Peferred Stock upon Cashless Warrant Exercise
|
|
|
-
|
|
-
|
|
|
-
|
|
|
(3)
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(3)
|
|
Preferred Stock Dividends
|
|
|
-
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(6,922)
|
|
|
(6,922)
|
|
Effect of Reverse Merger
|
|
|
(2)
|
|
1,003
|
|
|
-
|
|
|
2
|
|
|
-
|
|
|
-
|
|
|
|
|
|
-
|
|
Net loss
|
|
|
-
|
|
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(1,506)
|
|
|
(1,506)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2012
|
|
$
|
-
|
|
4,070
|
|
$
|
-
|
|
$
|
1,083
|
|
|
-
|
|
$
|
-
|
|
$
|
(43,798)
|
|
$
|
(42,715)
|
|
Preferred Stock Dividends
|
|
|
-
|
|
|
|
|
-
|
|
|
-
|
|
|
|
|
|
-
|
|
|
(4,975)
|
|
|
(4,975)
|
|
Non-cash Compensation Relating to Business Combination
|
|
|
-
|
|
-
|
|
|
-
|
|
|
4,418
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
4,418
|
|
Cancellation of Convertible Preferred Stock
|
|
|
-
|
|
-
|
|
|
-
|
|
|
53,726
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
53,726
|
|
Shares Issued in Merger
|
|
|
1
|
|
5,469
|
|
|
-
|
|
|
29,794
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
29,795
|
|
Stock-based Compensation Expense
|
|
|
-
|
|
-
|
|
|
-
|
|
|
36
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
36
|
|
Purchase of Common Stock for Treasury
|
|
|
-
|
|
-
|
|
|
-
|
|
|
-
|
|
|
59
|
|
|
(433)
|
|
|
-
|
|
|
(433)
|
|
Issuance of Common Stock upon Warrant Exercise
|
|
|
-
|
|
90
|
|
|
-
|
|
|
809
|
|
|
|
|
|
-
|
|
|
-
|
|
|
809
|
|
Treasury Stock Shares Issued as Restricted Stock
|
|
|
-
|
|
-
|
|
|
-
|
|
|
(365)
|
|
|
(50)
|
|
|
365
|
|
|
-
|
|
|
-
|
|
Net Income
|
|
|
-
|
|
-
|
|
|
-
|
|
|
-
|
|
|
|
|
|
-
|
|
|
301
|
|
|
301
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2013
|
|
$
|
1
|
|
9,629
|
|
$
|
-
|
|
$
|
89,501
|
|
|
9
|
|
$
|
(68)
|
|
$
|
(48,472)
|
|
$
|
40,962
|
|
53 | ||
|
For the years ended December 31,
|
|
2013
|
|
2012
|
|
||
|
|
|
|
|
|
|
|
Cash Flows From Operating Activities
|
|
|
|
|
|
|
|
Net income/(loss)
|
|
$
|
301
|
|
$
|
(1,506)
|
|
Adjustments to reconcile net loss to net cash and cash equivalents
used in operating activities: |
|
|
|
|
|
|
|
Stock-based compensation
|
|
|
36
|
|
|
-
|
|
Depreciation and amortization
|
|
|
1,110
|
|
|
567
|
|
Non-cash interest relating to equity-linked securities and loan cost amortization
|
|
|
217
|
|
|
1,071
|
|
Non-cash compensation relating to business combination
|
|
|
4,418
|
|
|
-
|
|
Changes in operating assets and liabilities, net of those acquired in business
combination: |
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(7,081)
|
|
|
(327)
|
|
Inventories
|
|
|
(708)
|
|
|
(702)
|
|
Prepaid expenses
|
|
|
(188)
|
|
|
(88)
|
|
Accounts payable
|
|
|
(565)
|
|
|
785
|
|
Accrued compensation
|
|
|
(2,854)
|
|
|
-
|
|
Accrued expenses, returned goods reserve and deferred revenue
|
|
|
25
|
|
|
205
|
|
|
|
|
|
|
|
|
|
Net Cash and Cash Equivalents Used in Continuing Operations
|
|
|
(5,289)
|
|
|
5
|
|
Net Cash Used in Discontinued Operation
|
|
|
(195)
|
|
|
(142)
|
|
|
|
|
|
|
|
|
|
Net Cash and Cash Equivalents Used in Operating Activities
|
|
|
(5,484)
|
|
|
(137)
|
|
|
|
|
|
|
|
|
|
Cash Flows From Investing Activities
|
|
|
|
|
|
|
|
Cash acquired in business combination
|
|
|
18,198
|
|
|
-
|
|
Release of restricted cash
|
|
|
2,260
|
|
|
|
|
Acquisition of property and equipment
|
|
|
(191)
|
|
|
(292)
|
|
|
|
|
|
|
|
|
|
Net Cash and Cash Equivalents Provided by/(Used in) Investing Activities
|
|
|
20,267
|
|
|
(292)
|
|
|
|
|
|
|
|
|
|
Cash Flows From Financing Activities
|
|
|
|
|
|
|
|
(Repayments)/borrowings under line of credit, net
|
|
|
(4,065)
|
|
|
1,001
|
|
Payment of debt issuance costs
|
|
|
-
|
|
|
(261)
|
|
Proceeds from warrant exercise
|
|
|
809
|
|
|
-
|
|
Treasury stock purchases
|
|
|
(433)
|
|
|
-
|
|
Net Cash and Cash Equivalents (Used in)/Provided by Continuing Operations
|
|
|
(3,689)
|
|
|
740
|
|
Net Cash Used in Discontinued Operation
|
|
|
-
|
|
|
(300)
|
|
|
|
|
|
|
|
|
|
Net Cash and Cash Equivalents (Used in)/Provided by Financing Activities
|
|
|
(3,689)
|
|
|
440
|
|
|
|
|
|
|
|
|
|
Change in Cash and Cash Equivalents
|
|
|
11,094
|
|
|
11
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, beginning of period
|
|
|
11
|
|
|
-
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period
|
|
$
|
11,105
|
|
$
|
11
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure for cash flow information:
|
|
|
|
|
|
|
|
Cash paid for interest
|
|
$
|
250
|
|
$
|
255
|
|
Supplemental non-cash investing and financing activities:
|
|
|
|
|
|
|
|
Issuance of common stock in connection with business combination
|
|
$
|
40,034
|
|
$
|
-
|
|
Cancellation of Series D, Series C, Series B, and Series A preferred stock
|
|
$
|
53,726
|
|
$
|
-
|
|
Acquired non-cash net assets
|
|
$
|
11,597
|
|
$
|
-
|
|
Preferred stock dividends accrued
|
|
$
|
4,975
|
|
$
|
6,922
|
|
Issuance of common and preferred stock upon cashless warrant exercise
|
|
$
|
-
|
|
$
|
5
|
|
Issuance of preferred stock upon convertible debt conversion
|
|
$
|
-
|
|
$
|
17,610
|
|
54 | ||
|
55 | ||
|
56 | ||
|
|
⋅
|
A change in customer mix
|
|
⋅
|
A change in negotiated terms with customers
|
|
⋅
|
A change in product sales mix
|
|
⋅
|
A change in the volume of off-contract purchases
|
|
⋅
|
Changes in WAC
|
57 | ||
|
58 | ||
|
(in thousands)
|
|
Accruals for Chargebacks, Returns and Other Allowances
|
|
||||||||||
|
|
Chargebacks
|
|
Returns
|
|
Administrative
Fees and Other Rebates |
|
Prompt
Payment Discounts |
|
||||
Balance at December 31, 2011
|
|
$
|
3,681
|
|
$
|
252
|
|
$
|
238
|
|
$
|
166
|
|
Accruals/Adjustments
|
|
|
22,912
|
|
|
698
|
|
|
1,369
|
|
|
775
|
|
Credits Taken Against Reserve
|
|
|
(20,931)
|
|
|
(539)
|
|
|
(1,376)
|
|
|
(699)
|
|
Balance at December 31, 2012
|
|
|
5,662
|
|
|
411
|
|
|
231
|
|
|
242
|
|
Accruals/Adjustments
|
|
|
28,009
|
|
|
1,595
|
|
|
2,355
|
|
|
1,129
|
|
Credits Taken Against Reserve
|
|
|
(29,595)
|
|
|
(1,270)
|
|
|
(1,851)
|
|
|
(1,039)
|
|
Balance at December 31, 2013
|
|
$
|
4,076
|
|
$
|
736
|
|
$
|
735
|
|
$
|
332
|
|
Buildings and improvements
|
20 - 40 years
|
Machinery, furniture and equipment
|
3 - 10 years
|
59 | ||
|
60 | ||
|
1.
|
DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
|
61 | ||
|
62 | ||
|
63 | ||
|
Category
|
|
(in thousands)
|
|
|
Legal fees
|
|
$
|
1,227
|
|
Accounting fees
|
|
|
122
|
|
Consulting fees
|
|
|
119
|
|
Monitoring and advisory fees
|
|
|
390
|
|
Transaction bonuses
|
|
|
4,801
|
|
Other
|
|
|
429
|
|
Total transaction costs
|
|
$
|
7,088
|
|
|
|
(in thousands)
|
|
|
Total purchase consideration
|
|
$
|
29,795
|
|
Assets acquired
|
|
|
|
|
Cash and cash equivalents
|
|
|
18,198
|
|
Restricted cash
|
|
|
2,260
|
|
Teva license intangible asset
|
|
|
10,900
|
|
Other tangible assets
|
|
|
79
|
|
Deferred tax assets, net
|
|
|
-
|
|
Goodwill
|
|
|
1,838
|
|
Total assets
|
|
|
33,275
|
|
Liabilities assumed
|
|
|
|
|
Accrued severance
|
|
|
2,965
|
|
Other liabilities
|
|
|
515
|
|
Total liabilities
|
|
|
3,480
|
|
Total net assets acquired
|
|
$
|
29,795
|
|
64 | ||
|
|
|
Year ended December 31,
|
|
||||
(in thousands)
|
|
2013
|
|
2012
|
|
||
Net revenues
|
|
$
|
30,228
|
|
$
|
22,671
|
|
Net income/(loss)
|
|
$
|
89
|
|
$
|
(27,718)
|
|
(in thousands)
|
|
2013
|
|
2012
|
|
||
Raw materials
|
|
$
|
1,480
|
|
$
|
975
|
|
Packaging materials
|
|
|
766
|
|
|
585
|
|
Work-in-progress
|
|
|
162
|
|
|
374
|
|
Finished goods
|
|
|
1,152
|
|
|
891
|
|
|
|
|
3,560
|
|
|
2,825
|
|
Reserve for excess/obsolete inventories
|
|
|
(42)
|
|
|
(15)
|
|
Inventories, net
|
|
$
|
3,518
|
|
$
|
2,810
|
|
65 | ||
|
(in thousands)
|
|
2013
|
|
2012
|
|
||
Land
|
|
$
|
87
|
|
$
|
87
|
|
Buildings
|
|
|
3,682
|
|
|
3,682
|
|
Machinery, furniture and equipment
|
|
|
3,736
|
|
|
3,565
|
|
Construction in progress
|
|
|
229
|
|
|
209
|
|
|
|
|
7,734
|
|
|
7,543
|
|
Less: accumulated depreciation
|
|
|
(3,197)
|
|
|
(2,663)
|
|
Property, Plant and Equipment, net
|
|
$
|
4,537
|
|
$
|
4,880
|
|
66 | ||
|
|
|
December 31, 2013
|
|
December 31, 2012
|
|
|
|
|
||||||||
(in thousands)
|
|
Gross Carrying
Amount |
|
Accumulated
Amortization |
|
Gross Carrying
Amount |
|
Accumulated
Amortization |
|
Amortization
Period |
|
|||||
Acquired ANDA intangible asset
|
|
$
|
60
|
|
$
|
(55)
|
|
$
|
60
|
|
$
|
-
|
|
|
3 years
|
|
Reglan
®
intangible asset
|
|
|
100
|
|
|
(100)
|
|
|
100
|
|
|
(75)
|
|
|
2 years
|
|
Teva license intangible asset
|
|
|
10,900
|
|
|
(496)
|
|
|
-
|
|
|
-
|
|
|
11 years
|
|
|
|
$
|
11,060
|
|
$
|
(651)
|
|
$
|
160
|
|
$
|
(75)
|
|
|
|
|
(in thousands)
|
|
|
|
|
2014
|
|
$
|
996
|
|
2015
|
|
|
991
|
|
2016
|
|
|
991
|
|
2017
|
|
|
991
|
|
2018
|
|
|
991
|
|
2019 and thereafter
|
|
|
5,449
|
|
Total
|
|
$
|
10,409
|
|
67 | ||
|
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Description
|
|
Fair Value at
December 31, 2013 |
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CVRs
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
Description
|
|
Fair Value at
December 31, 2012 |
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
68 | ||
|
69 | ||
|
Series
|
|
Shares
Authorized |
|
Shares
Issued and Outstanding |
|
Carrying
Value |
|
Stated Value
per share |
|
Dividend
Accrual per Annum |
|
|
Accrued
Dividends |
|
||||||
A
|
|
|
108
|
|
|
103
|
|
$
|
11,579
|
|
$
|
100
|
|
|
10
|
%
|
|
$
|
2,186
|
|
B
|
|
|
119
|
|
|
78
|
|
$
|
10,560
|
|
$
|
110
|
|
|
10
|
%
|
|
$
|
1,837
|
|
C
|
|
|
38
|
|
|
35
|
|
$
|
4,815
|
|
$
|
110
|
|
|
12
|
%
|
|
$
|
994
|
|
D
|
|
|
3,400
|
|
|
2,375
|
|
$
|
21,797
|
|
$
|
30
|
|
|
10
|
%
|
|
$
|
4,185
|
|
70 | ||
|
|
|
Number of
|
|
|
|
|
|
|
|
|
|
|
Underlying Shares
|
|
Per Share
|
|
|
|
|
||
Issue Date
|
|
Of Common Stock
|
|
Exercise Price
|
|
Expiration Date
|
|
|||
August 13, 2009
|
|
|
67
|
|
$
|
90.00
|
|
|
August 12, 2014
|
|
August 13, 2009
|
|
|
7
|
|
$
|
90.00
|
|
|
June 9, 2014
|
|
March 8, 2010
|
|
|
145
|
|
$
|
74.88
|
|
|
September 8, 2015
|
|
March 8, 2010
|
|
|
6
|
|
$
|
77.76
|
|
|
June 9, 2014
|
|
June 23, 2010
|
|
|
99
|
|
$
|
88.20
|
|
|
June 23, 2015
|
|
June 23, 2010
|
|
|
6
|
|
$
|
94.68
|
|
|
June 9, 2015
|
|
December 30, 2010
|
|
|
147
|
|
$
|
72.00
|
|
|
December 30, 2015
|
|
December 30, 2010
|
|
|
9
|
|
$
|
76.50
|
|
|
June 9, 2015
|
|
March 8, 2011
|
|
|
112
|
|
$
|
81.00
|
|
|
March 8, 2014
|
|
March 8, 2011
|
|
|
7
|
|
$
|
92.88
|
|
|
June 9, 2014
|
|
August 20, 2012
|
|
|
83
|
|
$
|
9.00
|
|
|
August 16, 2017
|
|
71 | ||
|
|
|
2013
|
|
Expected option life (years)
|
|
6.25
|
|
Risk-free interest rate
|
|
1.72
|
%
|
Expected stock price volatility
|
|
55.0
|
%
|
Dividend yield
|
|
|
|
72 | ||
|
(in thousands, except per share data)
|
|
Option
Shares |
|
Weighted
Average Exercise Price |
|
Weighted
Average Remaining Term |
|
Aggregate
Intrinsic Value |
|
||
Outstanding December 31, 2011
|
|
18
|
|
$
|
11.00
|
|
6.2
|
|
$
|
0
|
|
Granted
|
|
-
|
|
|
-
|
|
|
|
|
|
|
Exercised
|
|
-
|
|
|
-
|
|
|
|
|
0
|
|
Forfeited or expired
|
|
(18)
|
|
$
|
11.00
|
|
|
|
|
|
|
Outstanding December 31, 2012
|
|
-
|
|
|
-
|
|
-
|
|
$
|
|
|
Exercisable at December 31, 2012
|
|
-
|
|
|
-
|
|
-
|
|
$
|
|
|
Vested or expected to vest at December 31, 2012
|
|
-
|
|
|
-
|
|
-
|
|
$
|
|
|
Net BioSante Stock Options assumed
|
|
99
|
|
$
|
59.59
|
|
|
|
|
|
|
Granted
|
|
21
|
|
$
|
6.36
|
|
|
|
|
|
|
Exercised
|
|
-
|
|
|
-
|
|
|
|
|
|
|
Forfeited or expired
|
|
-
|
|
|
-
|
|
|
|
|
|
|
Outstanding December 31, 2013
|
|
120
|
|
$
|
50.35
|
|
2.4
|
|
$
|
81
|
|
Exercisable at December 31, 2013
|
|
99
|
|
$
|
59.59
|
|
0.9
|
|
$
|
|
|
Vested or expected to vest at December 31, 2013
|
|
120
|
|
$
|
50.35
|
|
2.4
|
|
$
|
81
|
|
73 | ||
|
(in thousands, except per share
data) |
|
Shares
|
|
Weighted
Average Grant Date Fair Value |
|
Weighted Average
Remaining Term (years) |
|
|
Unvested at December 31, 2012
|
|
-
|
|
$
|
-
|
|
|
|
Granted
|
|
50
|
|
$
|
10.20
|
|
|
|
Vested
|
|
-
|
|
$
|
-
|
|
|
|
Forfeited
|
|
-
|
|
$
|
-
|
|
|
|
Unvested at December 31, 2013
|
|
50
|
|
$
|
10.20
|
|
2.84
|
|
(in thousands)
|
|
2013
|
|
2012
|
|
||
|
|
|
|
|
|
|
|
Current income tax provision (benefit):
|
|
|
|
|
|
|
|
Federal
|
|
$
|
20
|
|
$
|
-
|
|
State
|
|
|
-
|
|
|
-
|
|
Total
|
|
|
20
|
|
|
-
|
|
|
|
|
|
|
|
|
|
Deferred income tax provision (benefit):
|
|
|
|
|
|
|
|
Federal
|
|
|
635
|
|
|
(1,486)
|
|
State
|
|
|
(221)
|
|
|
(35)
|
|
Total
|
|
|
414
|
|
|
(1,522)
|
|
|
|
|
|
|
|
|
|
Change in valuation allowance
|
|
|
(414)
|
|
|
1,522
|
|
|
|
|
|
|
|
|
|
Tax provision (benefit) from continuing operations
|
|
|
20
|
|
|
(36)
|
|
Tax provision from discontinued operation
|
|
|
38
|
|
|
36
|
|
Total provision (benefit) for income taxes
|
|
$
|
58
|
|
$
|
-
|
|
|
|
As of December 31,
|
|
|||||
(in thousands)
|
|
2013
|
|
|
2012
|
|
||
|
|
|
|
|
|
|
|
|
US Federal statutory rate
|
|
|
35.0
|
%
|
|
|
(34.0)
|
%
|
State taxes, net of Federal benefit
|
|
|
1.0
|
%
|
|
|
(0.9)
|
%
|
Non-deductible expenses
|
|
|
245.9
|
%
|
|
|
17.7
|
%
|
Change in valuation allowance
|
|
|
(300.4)
|
%
|
|
|
100.7
|
%
|
Change in tax rates and other
|
|
|
34.6
|
%
|
|
|
(85.7)
|
%
|
Total income tax provision (benefit)
|
|
|
16.1
|
%
|
|
|
(2.2)
|
%
|
74 | ||
|
|
|
As of December 31,
|
|
||||
(in thousands)
|
|
2013
|
|
2012
|
|
||
|
|
|
|
|
|
|
|
Deferred tax assets:
|
|
|
|
|
|
|
|
Accruals and advances
|
|
$
|
1,160
|
|
$
|
383
|
|
Net operating loss carryforward
|
|
|
16,409
|
|
|
11,271
|
|
Other
|
|
|
418
|
|
|
193
|
|
Total deferred tax assets
|
|
|
17,987
|
|
|
11,847
|
|
|
|
|
|
|
|
|
|
Deferred tax liabilities:
|
|
|
|
|
|
|
|
Depreciation
|
|
|
(220)
|
|
|
(236)
|
|
Intangible assets
|
|
|
(526)
|
|
|
-
|
|
Other
|
|
|
(374)
|
|
|
(52)
|
|
Total deferred tax liabilities
|
|
|
(1,120)
|
|
|
(288)
|
|
|
|
|
|
|
|
|
|
Valuation allowance
|
|
|
(16,867)
|
|
|
(11,559)
|
|
Total deferred tax asset (liability), net
|
|
$
|
-
|
|
$
|
-
|
|
75 | ||
|
76 | ||
|
(in thousands)
|
|
|
|
|
Year
|
|
Minimum
Annual Rental Payments |
|
|
2014
|
|
$
|
148
|
|
2015
|
|
|
78
|
|
2016
|
|
|
53
|
|
2017
|
|
|
44
|
|
2018
|
|
|
29
|
|
Thereafter
|
|
|
-
|
|
Total
|
|
$
|
352
|
|
77 | ||
|
78 | ||
|
79 | ||
|
80 | ||
|
81 | ||
|
82 | ||
|
83 | ||
|
84 | ||
|
(a)
|
Financial Statements:
|
|
The consolidated balance sheets of the Registrant as of December 31, 2013 and 2012, the related consolidated statements of operations, changes in stockholders' equity/(deficit), and cash flows for each of the years ended December 31, 2013 and 2012, the footnotes thereto, and the reports of EisnerAmper LLP, independent registered public accounting firm, are filed herewith.
|
|
|
(b)
|
Financial Statement Schedules:
|
|
All schedules have been omitted because they are not applicable or the required information is included in the consolidated financial statements or notes thereto.
|
|
|
(c)
|
Exhibits
|
|
Exhibits included or incorporated by reference herein: see Exhibit Index on page 84.
|
85 | ||
|
ANI PHARMACEUTICALS, INC.
|
|
|
|
|
|
By:
|
/
S
/ Arthur S. Przybyl
|
|
|
Arthur S. Przybyl
|
|
|
President and Chief Executive Officer
|
|
|
(principal executive officer)
|
|
|
|
|
By:
|
/
S
/ Charlotte C. Arnold
|
|
|
Charlotte C. Arnold
|
|
|
Vince President, Finance and
Chief Financial Officer
(principal financial officer)
|
|
Name
|
|
Capacity
|
|
Date
|
|
|
|
|
|
/
S
/ Arthur S. Przybyl
|
|
Director, President and
|
|
February 28, 2014
|
Arthur S. Przybyl
|
|
Chief Executive Officer
|
|
|
|
|
|
|
|
/
S
/ Robert E. Brown, Jr.
|
|
Director and Chairman of the Board of
|
|
February 28, 2014
|
Robert E. Brown, Jr.
|
|
Directors
|
|
|
|
|
|
|
|
/
S
/ Fred Holubow
|
|
Director
|
|
February 28, 2014
|
Fred Holubow
|
|
|
|
|
|
|
|
|
|
/
S
/ Ross Mangano
|
|
Director
|
|
February 28, 2014
|
Ross Mangano
|
|
|
|
|
|
|
|
|
|
/
S
/ Tracy L. Marshbanks, Ph.D.
|
|
Director
|
|
February 28, 2014
|
Tracy L. Marshbanks, Ph.D.
|
|
|
|
|
|
|
|
|
|
/
S
/ Thomas A. Penn
|
|
Director
|
|
February 28, 2014
|
Thomas A. Penn
|
|
|
|
|
|
|
|
|
|
/
S
/ Daniel Raynor
|
|
Director
|
|
February 28, 2014
|
Daniel Raynor
|
|
|
|
|
86 | ||
|
Exhibit
No. |
|
Exhibit
|
|
Method of Filing
|
|
|
|
|
|
2.1
|
|
Amended and Restated Agreement and Plan of Merger, dated as of April 12, 2013, by and among BioSante Pharmaceuticals, Inc., ANI Merger Sub, Inc. and ANIP Acquisition Company (1)
|
|
Incorporated by reference to Exhibit 2.1 to ANI's Current Report on Form 8-K as filed with the Securities and Exchange Commission on April 12, 2013 (File No. 001-31812)
|
|
|
|
|
|
2.2
|
|
Asset Purchase Agreement, dated as of December 26, 2013, by and between ANI Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc. (2)
|
|
Filed herewith
|
|
|
|
|
|
3.1
|
|
Certificate of Amendment of the Restated Certificate of Incorporation of BioSante Pharmaceuticals, Inc., dated as of July 17, 2013, Certificate of Amendment of the Restated Certificate of Incorporation of BioSante Pharmaceuticals, Inc., dated as of June 1, 2012, and Restated Certificate of Incorporation of BioSante Pharmaceuticals, Inc.
|
|
Incorporated by reference to Exhibit 3.1 to ANI's Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2013 (File No. 001-31812)
|
|
|
|
|
|
3.2
|
|
Amended and Restated Bylaws of BioSante Pharmaceuticals, Inc.
|
|
Incorporated by reference to Exhibit 3.1 to ANI's Current Report on Form 8-K as filed with the Securities and Exchange Commission on June 11, 2010 (File No. 001-31812)
|
|
|
|
|
|
4.1
|
|
Form of Common Stock Purchase Warrant issued by BioSante Pharmaceuticals, Inc. with an Initial Exercise Date of August 13, 2009
|
|
Incorporated by reference to Exhibit 4.1 to ANI's Current Report on Form 8-K as filed with the Securities and Exchange Commission on August 14, 2009 (File No. 001-31812)
|
|
|
|
|
|
4.2
|
|
Form of Common Stock Purchase Warrant issued by BioSante Pharmaceuticals, Inc. with an Initial Exercise Date of September 2010
|
|
Incorporated by reference to Exhibit 4.1 to ANI's Current Report on Form 8-K as filed with the Securities and Exchange Commission on March 5, 2010 (File No. 001-31812)
|
|
|
|
|
|
4.3
|
|
Form of Common Stock Purchase Warrant issued by BioSante Pharmaceuticals, Inc. with an Initial Exercise Date of June 2010
|
|
Incorporated by reference to Exhibit 4.1 to ANI's Current Report on Form 8-K as filed with the Securities and Exchange Commission on June 21, 2010 (File No. 001-31812)
|
|
|
|
|
|
4.4
|
|
Form of Common Stock Purchase Warrant issued by BioSante Pharmaceuticals, Inc. with an Initial Exercise Date of December 2010
|
|
Incorporated by reference to Exhibit 4.1 to ANI's Current Report on Form 8-K as filed with the Securities and Exchange Commission on December 29, 2010 (File No. 001-31812)
|
|
|
|
|
|
4.5
|
|
Form of Common Stock Purchase Warrant issued by BioSante Pharmaceuticals, Inc. with an Initial Exercise Date of March 2011
|
|
Incorporated by reference to Exhibit 4.1 to ANI's Current Report on Form 8-K as filed with the Securities and Exchange Commission on March 4, 2011 (File No. 001-31812)
|
Exhibit
No. |
|
Exhibit
|
|
Method of Filing
|
|
|
|
|
|
4.6
|
|
Form of Common Stock Purchase Warrant issued by BioSante Pharmaceuticals, Inc. with an Initial Exercise Date of August 2012
|
|
Incorporated by reference to Exhibit 4.1 to ANI's Current Report on Form 8-K as filed with the Securities and Exchange Commission on August 17, 2012 (File No. 001-31812)
|
|
|
|
|
|
10.1*
|
|
Amended and Restated Employment Letter Agreement, dated as of July 16, 2008, between BioSante Pharmaceuticals, Inc. and Stephen M. Simes
|
|
Incorporated by reference to Exhibit 10.1 to ANI's Current Report on Form 8-K as filed with the Securities and Exchange Commission on July 18, 2008 (File No. 001-31812)
|
|
|
|
|
|
10.2*
|
|
Amended and Restated Employment Letter Agreement, dated as of July 16, 2008, between BioSante Pharmaceuticals, Inc. and Phillip B. Donenberg
|
|
Incorporated by reference to Exhibit 10.2 to ANI's Current Report on Form 8-K as filed with the Securities and Exchange Commission on July 18, 2008 (File No. 001-31812)
|
|
|
|
|
|
10.3*
|
|
ANI Pharmaceuticals, Inc. Third Amended and Restated 2008 Stock Incentive Plan
|
|
Incorporated by reference to Exhibit 10.1 to ANI's Current Report on Form 8-K as filed with the Securities and Exchange Commission on June 1, 2012 (File No. 001-31812)
|
|
|
|
|
|
10.4*
|
|
Form of Incentive Stock Option Agreement under the ANI Pharmaceuticals, Inc. Third Amended and Restated 2008 Stock Incentive Plan
|
|
Incorporated by reference to Exhibit 10.2 to ANI's Current Report on Form 8-K as filed with the Securities and Exchange Commission on June 1, 2012 (File No. 001-31812)
|
|
|
|
|
|
10.5*
|
|
Form of Non-Statutory Option Agreement under the ANI Pharmaceuticals, Inc. Third Amended and Restated 2008 Stock Incentive Plan
|
|
Incorporated by reference to Exhibit 10.3 to ANI's Current Report on Form 8-K as filed with the Securities and Exchange Commission on June 1, 2012 (File No. 001-31812)
|
|
|
|
|
|
10.6*
|
|
Form of Non-Statutory Stock Option Agreement between ANI Pharmaceuticals, Inc. and its Non-Employee Directors Under the ANI Pharmaceuticals, Inc. Third Amended and Restated 2008 Stock Incentive Plan
|
|
Incorporated by reference to Exhibit 10.4 to ANI's Current Report on Form 8-K as filed with the Securities and Exchange Commission on June 13, 2008 (File No. 001-31812)
|
10.7*
|
|
BioSante Pharmaceuticals, Inc. Amended and Restated 1998 Stock Plan
|
|
Incorporated by reference to Exhibit 10.1 to ANI's Current Report on Form 8-K as filed with the Securities and Exchange Commission on June 12, 2006 (File No. 001-31812)
|
|
|
|
|
|
10.8*
|
|
Form of Incentive Stock Option Agreement Under the BioSante Pharmaceuticals, Inc. Amended and Restated 1998 Stock Plan
|
|
Incorporated by reference to Exhibit 10.30 to ANI's Annual Report on Form 10-KSB for the fiscal year ended December 31, 2003 (File No. 001-31812)
|
|
|
|
|
|
10.9*
|
|
Form of Non-Statutory Stock Option Agreement Under the BioSante Pharmaceuticals, Inc. Amended and Restated 1998 Stock Plan
|
|
Incorporated by reference to Exhibit 10.31 to ANI's Annual Report on Form 10-KSB for the fiscal year ended December 31, 2003 (File No. 001-31812)
|
Exhibit
No. |
|
Exhibit
|
|
Method of Filing
|
|
|
|
|
|
10.10*
|
|
Form of Indemnification Agreement between BioSante Pharmaceuticals, Inc. and each of its Directors and Executive Officers
|
|
Incorporated by reference to Exhibit 10.30 to ANI's Annual Report on Form 10-K for the fiscal year ended December 31, 2007 (File No. 001-31812)
|
|
|
|
|
|
10.11
|
|
License Agreement, dated June 13, 2000, between Permatec Technologie, AG (renamed as Antares Pharma IPL AG) and BioSante Pharmaceuticals, Inc. (3)
|
|
Incorporated by reference to Exhibit 10.27 to ANI's Annual Report on Form 10-K for the fiscal year ended December 31, 2010 (File No. 001-31812)
|
|
|
|
|
|
10.12
|
|
Amendment No. 1 to the License Agreement, dated May 20, 2001, by and between Antares Pharma IPL AG and BioSante Pharmaceuticals, Inc. (3)
|
|
Incorporated by reference to Exhibit 10.28 to ANI's Annual Report on Form 10-K for the fiscal year ended December 31, 2010 (File No. 001-31812)
|
|
|
|
|
|
10.13
|
|
Amendment No. 2 to the License Agreement, dated July 5, 2001, between Antares Pharma IPL AG and BioSante Pharmaceuticals, Inc. (3)
|
|
Incorporated by reference to Exhibit 10.19 to ANI's Annual Report on Form 10-KSB40 for the fiscal year ended December 31, 2001 (File No. 0-28637)
|
|
|
|
|
|
10.14
|
|
Amendment No. 3 to the License Agreement, dated August 30, 2001,
between Antares Pharma IPL AG and BioSante Pharmaceuticals, Inc. (3)
|
|
Incorporated by reference to Exhibit 10.30 to ANI's Annual Report on Form 10-K for the fiscal year ended December 31, 2010 (File No. 001-31812)
|
|
|
|
|
|
10.15
|
|
Amendment No. 4 to the License Agreement, dated August 8, 2002, between Antares Pharma IPL AG and BioSante Pharmaceuticals, Inc. (3)
|
|
Incorporated by reference to Exhibit 10.31 to ANI's Annual Report on Form 10-K for the fiscal year ended December 31, 2010 (File No. 001-31812)
|
|
|
|
|
|
10.16
|
|
Amendment No. 5 to the License Agreement, dated December 30, 2002, between Antares Pharma IPL AG and BioSante Pharmaceuticals, Inc.
|
|
Incorporated by reference to Exhibit 10.32 to ANI's Annual Report on Form 10-K for the fiscal year ended December 31, 2010 (File No. 001-31812)
|
|
|
|
|
|
10.17
|
|
Amendment No. 6 to the License Agreement, dated October 20, 2006,
between Antares Pharma IPL AG and BioSante Pharmaceuticals, Inc. and Letters, dated October 27, 2006, November 6, 2006, and November 7, 2006, from BioSante Pharmaceuticals to Antares Pharma IPL AG Regarding the License Agreement (3)
|
|
Incorporated by reference to Exhibit 10.33 to ANI's Annual Report on Form 10-K for the fiscal year ended December 31, 2010 (File No. 001-31812)
|
|
|
|
|
|
10.18
|
|
License Agreement, dated December 3, 2008, by and between BioSante Pharmaceuticals, Inc. and Azur Pharma International II Limited (3)
|
|
Incorporated by reference to Exhibit 10.1 to ANI's Current Report on Form 8-K/A as filed with the Securities and Exchange Commission on June 7, 2010 (File No. 001-31812)
|
|
|
|
|
|
10.19
|
|
Amendment No. 1 to License Agreement and Asset Purchase Agreement, dated November 30, 2009, by and between BioSante Pharmaceuticals, Inc. and Azur Pharma International II Limited (3)
|
|
Incorporated by reference to Exhibit 10.2 to ANI's Current Report on Form 8-K/A as filed with the Securities and Exchange Commission on June 7, 2010 (File No. 001-31812)
|
Exhibit
No. |
|
Exhibit
|
|
Method of Filing
|
|
|
|
|
|
10.20
|
|
Development and License Agreement, dated December 27, 2002, between BioSante Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc.
|
|
Incorporated by reference to Exhibit 10.2 to ANI's Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2012 (File No. 001-31812)
|
|
|
|
|
|
10.21
|
|
First Amendment to Development and License Agreement, dated March 13, 2003, between BioSante Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc.
|
|
Incorporated by reference to Exhibit 10.3 to ANI's Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2012 (File No. 001-31812)
|
|
|
|
|
|
10.22
|
|
Letter Agreement, dated June 4, 2007, between BioSante Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc. Regarding Development and License Agreement between Teva Pharmaceuticals USA, Inc. and BioSante Pharmaceuticals, Inc. effective December 27, 2002
|
|
Incorporated by reference to Exhibit 10.4 to ANI's Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2012 (File No. 001-31812)
|
|
|
|
|
|
10.23
|
|
Third Amendment to Development and License Agreement, effective October 18, 2012, by and between Teva Pharmaceuticals USA, Inc. and BioSante Pharmaceuticals, Inc.
|
|
Incorporated by reference to Exhibit 10.5 to ANI's Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2012 (File No. 001-31812)
|
|
|
|
|
|
10.24
|
|
Department of Veterans Affairs Federal Supply Schedule Contract Award to ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc., effective July 15, 2012, and Product Number Change Request, dated August 22, 2012
|
|
Incorporated by reference to Exhibit 10.54 to ANI's Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on December 11, 2012 (File No. 333-185391)
|
|
|
|
|
|
10.25
|
|
Sublicense Agreement, dated as of October 30, 2009, by and between ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc., and Jazz Pharmaceuticals, Inc. (3)
|
|
Incorporated by reference to Exhibit 10.55 to ANI's Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on December 11, 2012 (File No. 333-185391)
|
|
|
|
|
|
10.26
|
|
Supplier Agreement Multisource and Onestop Generics Program, dated as of November 1, 2010, by and between McKesson Corporation and ANIP Acquisition Company (3)
|
|
Incorporated by reference to Exhibit 10.56 to ANI's Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on December 11, 2012 (File No. 333-185391)
|
|
|
|
|
|
10.27
|
|
Master Product Development and Collaboration Agreement, dated as of July 11, 2011, by and among ANIP Acquisition Company d/b/a ANI Pharmaceuticals, Inc. and RiconPharma LLC (3)
|
|
Incorporated by reference to Exhibit 10.57 to ANI's Amendment No. 1 to Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on January 18, 2013 (File No. 333-185391)
|
|
|
|
|
|
10.28
|
|
Amended and Restated Manufacturing and Supply Agreement, dated as of June 10, 2008, between ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc., and Alaven Pharmaceuticals, LLC. and Addendum No. 1 thereto, dated as of December 1, 2010, and Addendum No. 2 thereto, dated as of July 10, 2012 (3)
|
|
Incorporated by reference to Exhibit 10.58 to ANI's Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on December 11, 2012 (File No. 333-185391)
|
Exhibit
No. |
|
Exhibit
|
|
Method of Filing
|
|
|
|
|
|
10.29
|
|
Generic Wholesale Service Agreement, dated as of May 1, 2006, between ANI Pharmaceuticals, Inc. and Cardinal Health, First Amendment to Generic Wholesale Service Agreement, dated as of July 10, 2008, Letter Agreement, dated as of July 10, 2008, regarding assignment of the Generic Wholesale Service Agreement to ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc., Letter from Cardinal Health, dated December 22, 2008 Regarding Increase in Base Service Fee, and Second Amendment to Generic Wholesale Service Agreement, dated May 7, 2012 (3)
|
|
Incorporated by reference to Exhibit 10.59 to ANI's Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on December 11, 2012 (File No. 333-185391)
|
|
|
|
|
|
10.30
|
|
Development, Manufacturing and Supply Agreement, dated as of February 5, 2009, by and between ANI Pharmaceuticals, Inc. and County Line Pharmaceuticals, LLC, and Addendum to Development, Manufacturing and Supply Agreement, dated as of June 12, 2012 (3)
|
|
Incorporated by reference to Exhibit 10.60 to ANI's Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on December 11, 2012 (File No. 333-185391)
|
|
|
|
|
|
10.31
|
|
Manufacturing Transfer and Supply Agreement, dated March 31, 2010, by and between ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc., and County Line Pharmaceuticals, LLC, and Addendum to Manufacturing Transfer and Supply Agreement, dated as of June 12, 2012(3)
|
|
Incorporated by reference to Exhibit 10.61 to ANI's Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on December 11, 2012 (File No. 333-185391)
|
|
|
|
|
|
10.32*
|
|
Employment Letter Agreement, dated February 25, 2009, by and between ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.,
and Arthur S. Przybyl
|
|
Incorporated by reference to Exhibit 10.62 to ANI's Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on December 11, 2012 (File No. 333-185391)
|
|
|
|
|
|
10.33*
|
|
Employment Letter Agreement, dated May 6, 2009, by and between ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.,
and Charlotte C. Arnold
|
|
Incorporated by reference to Exhibit 10.63 to ANI's Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on December 11, 2012 (File No. 333-185391)
|
|
|
|
|
|
10.34*
|
|
Employment Agreement, dated as of May 1, 2007, by and between ANIP Acquisition Company and James Marken
|
|
Incorporated by reference to Exhibit 10.64 to ANI's Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on December 11, 2012 (File No. 333-185391)
|
|
|
|
|
|
10.35*
|
|
Transaction Bonus Agreement, dated September 22, 2012, by and between ANIP Acquisition Company and Arthur Przybyl
|
|
Incorporated by reference to Exhibit 10.65 to ANI's Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on December 11, 2012 (File No. 333-185391)
|
|
|
|
|
|
10.36*
|
|
Transaction Bonus Agreement, dated September 22, 2012, by and between ANIP Acquisition Company and Charlotte Arnold
|
|
Incorporated by reference to Exhibit 10.66 to ANI's Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on December 11, 2012 (File No. 333-185391)
|
Exhibit
No. |
|
Exhibit
|
|
Method of Filing
|
|
|
|
|
|
10.37*
|
|
Transaction Bonus Agreement, dated September 22, 2012, by and between ANIP Acquisition Company and James Marken
|
|
Incorporated by reference to Exhibit 10.67 to ANI's Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on December 11, 2012 (File No. 333-185391)
|
|
|
|
|
|
10.38*
|
|
Transaction Bonus Agreement, dated September 22, 2012, by and between ANIP Acquisition Company and Robert Jamnick
|
|
Incorporated by reference to Exhibit 10.68 to ANI's Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on December 11, 2012 (File No. 333-185391)
|
|
|
|
|
|
10.39
|
|
Letter Agreement regarding fee payment, dated as of October 3, 2012, by and between ANIP Acquisition Company and MVP Management Company
|
|
Incorporated by reference to Exhibit 10.69 to ANI's Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on December 11, 2012 (File No. 333-185391)
|
|
|
|
|
|
10.40
|
|
Letter Agreement regarding fee payment, dated as of October 3, 2012, by and between ANIP Acquisition Company and Healthcare Value Capital LLC
|
|
Incorporated by reference to Exhibit 10.70 to ANI's Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on December 11, 2012 (File No. 333-185391)
|
|
|
|
|
|
10.41
|
|
Loan and Security Agreement, dated June 6, 2012, between Alostar Bank of Commerce and ANIP Acquisition Company
|
|
Incorporated by reference to Exhibit 10.71 to ANI's Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on December 11, 2012 (File No. 333-185391)
|
|
|
|
|
|
10.42
|
|
Note Purchase Agreement, dated as of January 28, 2011, between ANIP Acquisition Company, Meridian Venture Partners II, L.P. and the other parties thereto
|
|
Incorporated by reference to Exhibit 10.72 to ANI's Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on December 11, 2012 (File No. 333-185391)
|
|
|
|
|
|
10.43*
|
|
Amendment No. 1 to Transaction Bonus Agreement, dated December 28, 2012, by and between ANIP Acquisition Company and Arthur S. Przybyl
|
|
Incorporated by reference to Exhibit 10.73 to ANI's Amendment No. 1 to Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on January 18, 2013 (File No. 333-185391)
|
|
|
|
|
|
10.44*
|
|
Amendment No. 1 to Transaction Bonus Agreement, dated December 28, 2012, by and between ANIP Acquisition Company and Charlotte Arnold
|
|
Incorporated by reference to Exhibit 10.74 to ANI's Amendment No. 1 to Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on January 18, 2013 (File No. 333-185391)
|
|
|
|
|
|
10.45*
|
|
Amendment No. 2 to Transaction Bonus Agreement, dated April 12, 2013, by and between ANIP Acquisition Company and Arthur Przybyl
|
|
Incorporated by reference to Exhibit 10.81 to ANI's Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on April 26, 2013 (File No. 333-188174)
|
Exhibit
No. |
|
Exhibit
|
|
Method of Filing
|
|
|
|
|
|
10.46*
|
|
Amendment No. 2 to Transaction Bonus Agreement, dated April 12, 2013, by and between ANIP Acquisition Company and Charlotte Arnold
|
|
Incorporated by reference to Exhibit 10.82 to ANI's Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on April 26, 2013 (File No. 333-188174)
|
|
|
|
|
|
10.47*
|
|
Amendment No. 1 to Transaction Bonus Agreement, dated April 12, 2013, by and between ANIP Acquisition Company and James Marken
|
|
Incorporated by reference to Exhibit 10.83 to ANI's Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on April 26, 2013 (File No. 333-188174)
|
|
|
|
|
|
10.48*
|
|
Amendment No. 1 to Transaction Bonus Agreement, dated April 12, 2013, by and between ANIP Acquisition Company and Robert Jamnick
|
|
Incorporated by reference to Exhibit 10.84 to ANI's Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on April 26, 2013 (File No. 333-188174)
|
|
|
|
|
|
10.49
|
|
First Amendment to Loan and Security Agreement, dated as of April 11, 2013, between Alostar Bank of Commerce and ANIP Acquisition Company
|
|
Incorporated by reference to Exhibit 10.85 to ANI's Registration Statement on Form S-4 as filed with the Securities and Exchange Commission on April 26, 2013 (File No. 333-188174)
|
|
|
|
|
|
10.50*
|
|
Amendment No. 3 to Transaction Bonus Agreement, dated as of June 18, 2013, by and between ANIP Acquisition Company and Arthur S. Przybyl
|
|
Incorporated by reference to Exhibit 10.1 to ANI's Current Report on Form 8-K as filed with the Securities and Exchange Commission on June 21, 2013 (File No. 001-31812)
|
|
|
|
|
|
10.51*
|
|
Amendment No. 3 to Transaction Bonus Agreement, dated as of June 18, 2013, by and between ANIP Acquisition Company and Charlotte Arnold
|
|
Incorporated by reference to Exhibit 10.2 to ANI's Current Report on Form 8-K as filed with the Securities and Exchange Commission on June 21, 2013 (File No. 001-31812)
|
|
|
|
|
|
10.52*
|
|
Employment Letter Agreement, dated July 11, 2013, by and between ANIP Acquisition Company d/b/a ANI Pharmaceuticals, Inc.
and Robert Schrepfer
|
|
Filed herewith
|
|
|
|
|
|
16.1
|
|
Letter from Deloitte & Touche LLP, dated June 20, 2013, regarding change in certifying accountants
|
|
Incorporated by reference to Exhibit 16.1 to ANI's Current Report on Form 8-K as filed with the Securities and Exchange Commission on June 21, 2013 (File No. 001-31812)
|
|
|
|
|
|
21
|
|
List of subsidiaries
|
|
Filed herewith
|
|
|
|
|
|
23.1
|
|
Consent of EisnerAmper LLP
|
|
Filed herewith
|
|
|
|
|
|
31.1
|
|
Certification of Chief Executive Officer Pursuant to SEC Rule 13a-14
|
|
Filed herewith
|
|
|
|
|
|
31.2
|
|
Certification of Chief Financial Officer Pursuant to SEC Rule 13a-14
|
|
Filed herewith
|
|
|
|
|
|
32.1
|
|
Certification of Chief Executive Officer and Chief Financial Officer Pursuant to Rule 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
Furnished herewith
|
Exhibit
No. |
|
Exhibit
|
|
Method of Filing
|
|
|
|
|
|
|
|
101**
|
|
The following materials from ANI Pharmaceuticals, Inc.’s Annual Report on Form 10-K for the fiscal year ended December 31, 2013, formatted in XBRL (Extensible Business Reporting Language):
(i) the audited consolidated Balance Sheets, (ii) the audited consolidated Statements of Operations, (iii) the audited consolidated Statements of Stockholders’ Equity; (iv) the audited consolidated Statements of Cash Flows, and (v) Notes to consolidated Financial Statements.
|
|
Furnished herewith
|
|
|
|
|
|
|
|
(1)
|
All exhibits to this exhibit have been omitted pursuant to Item 601(b)(2) of Regulation S-K. ANI will furnish the omitted exhibits to the SEC upon request by the SEC.
|
|
|
(2)
|
Confidential treatment has been requested with respect to redacted portions of this document.
|
|
|
(3)
|
Confidential treatment has been granted with respect to redacted portions of this document.
|
|
|
*
|
Management contract or compensatory plan or arrangement required to be filed as an exhibit to this annual report on Form 10 K pursuant to Item 15(a).
|
|
|
**
|
Pursuant to Rule 406T of Regulation S-T, the XBRL related information in Exhibit 101 to this annual report on Form 10-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, and shall not be deemed part of a registration statement, prospectus or other document filed under Section 11 or 12 of the Securities Act of 1933, as amended, or otherwise subject to the liability of those sections, except as shall be expressly set forth by specific reference in such filings.
|
1. | For purposes of this Agreement, the following terms have the following meanings: |
1 | ||
|
2 | ||
|
3 | ||
|
4 | ||
|
5 | ||
|
6 | ||
|
7 | ||
|
8 | ||
|
9 | ||
|
10 | ||
|
11 | ||
|
12 | ||
|
13 | ||
|
By:
|
/s/ Allan Oberman
|
|
Name:
|
Allan Oberman
|
|
Title:
|
President and CEO, Teva Americas Generics
|
|
|
|
|
|
|
|
By:
|
/s/ Vikram Seoni
|
|
Name:
|
Vikram Seoni
|
|
Title:
|
SVP, Business Development & Alliance Management
|
|
By:
|
/s/ Charlotte C. Arnold
|
|
Name:
|
Charlotte C. Arnold
|
|
Title:
|
VP & Chief Financial Officer
|
|
14 | ||
|
ANDA
|
|
PRODUCT
|
77979
|
|
ALPRAZOLAM EXTENDED RELEASE TABLET, 0.5 mg, 1 mg, 2 mg and 3 mg
|
|
|
|
77725
|
|
ALPRAZOLAM EXTENDED RELEASE TABLET, 0.5 mg, 1 mg, 2 mg and 3 mg
|
|
|
|
65278
|
|
CEFADROXIL/CEFADROXIL HEMIHYDRATE FOR SUSPENSION, EQ 250 mg base/5 mL, 500 mg base/5 mL
|
|
|
|
62698
|
|
CEFADROXIL/CEFADROXIL HEMIHYDRATE FOR SUSPENSION, EQ. 125 mg base/5 mL, 250 mg base mL/5 mL, 500 mg base/5 mL
|
|
|
|
88921
|
|
CHLORPROPAMIDE TABLET, 100 mg
|
|
|
|
88812
|
|
CHLORPROPAMIDE TABLETS,
100 mg
|
|
|
|
89446
|
|
CHLORPROPAMIDE TABLET, 100 mg
|
|
|
|
89447
|
|
CHLORPROPAMIDE TABLET, 250 mg
|
|
|
|
88813
|
|
CHLORPROPAMIDE TABLET, 250 mg
|
|
|
|
88918
|
|
CHLORPROPAMIDE TABLET, 100 mg
|
|
|
|
88919
|
|
CHLORPROPAMIDE TABLET, 250 mg
|
|
|
|
88840
|
|
CHLORPROPAMIDE TABLETS, 100 mg
|
87353
|
|
CHLORPROPAMIDE TABLETS, 250 mg
|
88768
|
|
CHLORPROPAMIDE TABLET,
100 mg
|
|
|
|
88641
|
|
CHLORPROPAMIDE TABLET, 250 mg
|
|
|
|
88922
|
|
CHLORPROPAMIDE TABLET, 250 mg
|
|
|
|
74859
|
|
CIMETIDINE HYDROCHLORIDE SOLUTION, 300 mg/5 mL
|
|
|
|
74610
|
|
CIMETIDINE HYDROCHLORIDE SOLUTION, EQ 300 mg base/5 mL
|
|
|
|
75110
|
|
CIMETIDINE HYDROCHLORIDE SOLUTION, 300 mg/5 mL
|
71800
|
|
DESIPRAMINE HYDROCHLORIDE TABLET, 25 mg
|
15 | ||
|
71801
|
|
DESIPRAMINE HYDROCHLORIDE TABLET, 50 mg
|
|
|
|
71802
|
|
DESIPRAMINE HYDROCHLORIDE TABLET,
75 mg
|
|
|
|
71803
|
|
DESIPRAMINE HYDROCHLORIDE TABLET, 100 mg
|
71804
|
|
DESIPRAMINE HYDROCHLORIDE TABLET. 150 ,g
|
88682
|
|
DEXCHLORPHENIRAMINE MALEATE, 2 mg
|
|
|
|
61591
|
|
ERYTHROMYCIN STEARATE TABLET, EQ 250 mg
|
|
|
|
63179
|
|
ERYTHROMYCIN STEARATE TABLET, 500 mg
|
61461
|
|
ERYTHROMYCIN STEARATE TABLET, 250 mg and 500 mg
|
75126
|
|
ETODOLAC CAPSULE, 200 mg and 300 mg
|
|
|
|
74899
|
|
ETODOLAC CAPSULE, 200 mg and 300 mg
|
81310
|
|
FLUPHENAZINE HYDROCHLORIDE ELIXIR, ORAL, 2.5 mg/5 mL
|
73058
|
|
FLUPHENAZINE HYDROCHLORIDE CONCENTRATE, ORAL, 5 mg/ml
|
89441
|
|
EXTENDED PHENYTOIN SODIUM, 100 mg
|
|
|
|
74149
|
|
GUANABENZ ACETATE TABLET, EQ. 4 mg base, 8 mg base
|
|
|
|
74267
|
|
GUANABENZ ACETATE TABLET, 4 mg and 8 mg
|
75147
|
|
ISOSORBIDE MONONITRATE TABLET, 20 mg
|
|
|
|
78730
|
|
LANSOPRAZOLE DELAYED RELEASE TABLETS, 15 mg and 30 mg
|
|
|
|
40001
|
|
METHAZOLAMIDE TABLET, 25 mg, 50 mg
|
|
|
|
74540
|
|
NICARDIPINE HYDROCHLORIDE CAPSULE, 20 mg and 30 mg
|
|
|
|
74439
|
|
NIZATIDINE CAPSULES,
20 mg, 30 mg
|
|
|
|
75461
|
|
NIZATIDINE CAPSULES, 150 mg, 300 mg
|
|
|
|
75668
|
|
NIZATIDINE CAPSULES, 150 mg and 300 mg
|
|
|
|
78005
|
|
OXCARBAZEPINE TABLET, 150 mg, 300 mg and 600 mg
|
|
|
|
78138
|
|
PERINDOPRIL ERBUMINE TABLET,
2 mg, 4 mg and 8 mg
|
|
|
|
89457
|
|
PERPHENAZINE TABLET, 16 mg
|
89708
|
|
PERPHENAZINE TABLET, 4 mg
|
89707
|
|
PERPHENAZINE TABLET, 2 mg
|
16 | ||
|
89456
|
|
PERPHENAZINE TABLET, 8 mg
|
|
|
|
88958
|
|
PROCAINAMIDE HYDROCHLORIDE EXTENDED RELEASE TABLET, 250 mg
|
|
|
|
88959
|
|
PROCAINAMIDE HYDROCHLORIDE EXTEDNED RELEASE TABLET, 500 mg
|
|
|
|
88974
|
|
PROCAINAMIDE HYDROCHLORIDE EXTEDNED RELEASE TABLET
|
89438
|
|
PROCAINAMIDE HYDROCHLORIDE EXTENDED RELEASE TABLET, 750 mg
|
|
|
|
40111
|
|
PROCAINAMIDE HYDROCHLORIDE EXTENDED RELEASE TABLET, 1 gm
|
|
|
|
40435
|
|
EXTENDED PHENYTOIN SODIUM CAPSULE, 100 mg
|
80259
|
|
PROMPT PHENYTOIN SODIUM CAPSULE, 100 mg
|
|
|
|
76550
|
|
PROPAFENONE HYDROCHLORIDE TABLET, 150 mg,
225 mg, 300 mg
|
|
|
|
71977
|
|
PROPRANOLOL HYDROCHLORIDE TABLETS, 90 mg
|
80215
|
|
PROPYLTHIOURACIL TABLET, 50 mg
|
|
|
|
76440
|
|
RISPERIDONE SOLUTION, 1 mg/mL
|
|
|
|
76287
|
|
FLUOXETINE HYDROCHLORIDE CAPSULE, EQ. 10 mg base, EQ. 20 mg base
|
|
|
|
88194
|
|
THIORIDAZINE HYDROCHLORIDE TABLET, 50 mg
|
88270
|
|
THIORIDAZINE HYDROCHLORIDE TABLET, 10 mg
|
88271
|
|
THIORIDAZINE HYDROCHLORIDE TABLET, 15 mg
|
88272
|
|
THIORIDAZINE HYDROCHLORIDE TABLET, 25 mg
|
88273
|
|
THIORIDAZINE HYDROCHLORIDE TABLET, 100 mg
|
89603
|
|
THIORIDAZINE HYDROCHLORIDE CONCENTRATE, 5 mg/mL
|
89602
|
|
THIORIDAZINE HYDROCHLORIDE CONCENTRATE, 5 mg/mL
|
88456
|
|
THIORIDAZINE HYDROCHLORIDE CONCENTRATE, 5 mg/mL
|
88493
|
|
THIORIDAZINE HYDROCHLORIDE CONCENTRATE, 5 mg/mL
|
73178
|
|
VALPROIC ACID SYRUP, 250 mg/5 mL
|
|
|
|
77639
|
|
ZONISAMIDE CAPSULE, 100 mg, 25 mg, 50 mg
|
|
|
|
77641
|
|
ZONISAMIDE CAPSULE, 25 mg, 50 mg,
100 mg
|
17 | ||
|
18 | ||
|
|
TEVA PHARMACEUTICALS USA, INC.
|
|
|
|
|
|
|
|
|
By:
|
|
|
|
Name:
|
|
|
Title:
|
|
|
|
|
|
|
|
By:
|
|
|
|
Name:
|
|
|
Title:
|
|
|
|
|
|
|
|
ANI PHARMACEUTICALS, INC.
|
|
|
|
|
|
|
|
|
By:
|
|
|
|
Name:
|
|
|
Title:
|
19 | ||
|
20 | ||
|
|
TEVA PHARMACEUTICALS USA, INC.
|
|
|
|
|
|
|
|
|
By:
|
|
|
|
Name:
|
|
|
Title:
|
|
|
|
|
|
|
|
By:
|
|
|
|
Name:
|
|
|
Title:
|
21 | ||
|
|
ANI PHARMACEUTICALS, INC.
|
|
|
|
|
|
|
|
|
By:
|
|
|
|
Name:
|
|
|
Title:
|
22 | ||
|
· | [***] for Product Year 1 through Product Year [***] |
23 | ||
|
24 | ||
|
Re:
|
ANDA XXXXXX
|
|
[Product name and strength]
|
Former Owner of Applicant:
|
New Owner of Applicant:
|
XXX Pharmaceuticals
Number and Street Name
City, State, Zip Code
Country
|
XXX Pharmaceuticals
Number and Street Name
City, State, Zip Code
Country
|
25 | ||
|
|
1. | Your position will be as a regular full-time employee commencing on August 12, 2013. Your business office will be located in Wilmington, Delaware. As a regular full-time employee, you will be expected to devote all of your business time and best efforts to the performance of your duties and responsibilities to the Company, as these may be changed by the Company from time to time. |
2. | Your annual base salary will be $245,000 (less applicable required withholding and deductions). Your salary will be paid bi-weekly in accordance with the Company’s standard payroll policies. |
3. | You will be eligible for an annual bonus of up to 40% of your annual base salary measured by corporate and individual objectives. You will be eligible to receive a $75,000 bonus for 2013. The objectives for 2013 have been set forth based on ANI’s 2013 approved budget. The Compensation Committee of the Board of Directors will determine whether and to what extent the objectives have been met. |
4. | You will be granted stock options as determined and approved by the Compensation Committee of the Board of Directors, in an amount equal to 177,500 stock options. The stock option grant will be governed by the Company’s stock option plan. You will also be eligible to be considered for additional stock option grants in later years, subject to approval by the Compensation Committee of the Board of Directors. |
5. | As a signing bonus, you will receive 100,000 stock options that vest in four (4) equal installments on the annual anniversary of the grant date. |
6. | You will be entitled to four weeks’ vacation each year, accruing in accordance with the vacation policies established by the Company. |
210 Main Street West
, Baudette, MN 56623
•
Phone (218)-634-3500
•
Fax (218)-634-3540
Toll-Free (800) 434-1121
|
|
7. | You will be eligible to participate, effective on your first day of employment, in the Company’s other employee benefit plans as they are generally made available to other employees of similar status and service, including the right to participate in a Company-sponsored medical, dental, vision and life insurance plans. You will also be eligible to participate in the ANI Pharmaceuticals 401(k) plan after 3 months of service. These benefits, as well as all other Company compensation and benefit programs, are subject to change from time to time as deemed appropriate and necessary by the Company. |
8. | You will be reimbursed for all customary business expenses reasonably incurred by you in the course of your employment that are documented and submitted in accordance with the Company’s policies. |
9. | As a condition of employment, you will be required to sign the Company’s standard form of confidentiality, Invention Assignment and Non-Competition Agreement. By accepting this offer, you agree that you will not bring with you to the Company, or use in any way during your employment with the Company, any confidential information, trade secrets or proprietary material or processes of any former employer, entity, trust or individual for which you have performed services. You further confirm that by accepting this offer you will not breach any contract, agreement or other instrument to which you are a party or are bound. |
10. | Please note that this letter and your response do not create a contract or promise of employment for a definite period of time. Therefore, you are free to resign for any reason or for no reason. Similarly, the Company is free to conclude its at-will employment relationship with you at any time, with or without cause. We do request, however, that you give a reasonable notice if you decide to terminate your employment with us. Notwithstanding anything to the contrary stated in this letter, if the Company terminates your employment without cause, upon the receipt from you of a release in form and substance satisfactory to the Company, the Company will (i) pay you severance in an amount equal to your base salary for a period of 12 months, which amount may be paid, at the Company’s election, either in a lump sum or by salary continuation, (ii) pay or reimburse you for the premiums to continue your health insurance coverage as in effect at the time of the termination of employment for a period of 12 months under the Consolidated Omnibus Budget Reconciliation Act. |
11. | You agree to resign from your current position on the ANI Pharmaceuticals Board of Directors at the time you sign this offer letter. |
12. | You will be subject to and expect to abide by the Company’s policies and procedures, as these may be changed from time to time. |
13. | This offer expires at 5:00 p.m. on July 12, 2013, if not accepted by then. |
14. | This offer is subject to successful completion of a pre-employment background and reference checks and documentation of eligibility to work in the United States, to be completed as soon as possible following your acceptance of this offer. |
210 Main Street West
, Baudette, MN 56623
•
Phone (218)-634-3500
•
Fax (218)-634-3540
Toll-Free (800) 434-1121
|
|
15. | By accepting this offer, you represent that you have not relied on any agreements or representations, written or oral, express or implied, with respect to your employment that are not set forth expressly in this letter. Notwithstanding anything to the contrary set forth herein, the Company may terminate this offer at any time prior to the commencement of your employment. |
/s/ Robert W. Schrepfer
|
|
July 12, 2013
|
Name
|
|
Date
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210 Main Street West
, Baudette, MN 56623
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Phone (218)-634-3500
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Fax (218)-634-3540
Toll-Free (800) 434-1121
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Name
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State of Incorporation
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ANIP Acquisition Company
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Delaware
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1.
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I have reviewed this annual report on Form 10-K of ANI Pharmaceuticals, Inc.;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a15(e) and 15d15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a15(f) and 15d15(f)) for the registrant and have:
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(a)
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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(b)
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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(c)
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Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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(d)
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Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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5.
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The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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(a)
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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(b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: February 28, 2014
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/s/ Arthur S. Przybyl
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Arthur S. Przybyl President and Chief Executive Officer
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2.
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I have reviewed this annual report on Form 10-K of ANI Pharmaceuticals, Inc.;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a15(e) and 15d15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a15(f) and 15d15(f)) for the registrant and have:
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(a)
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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(b)
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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(c)
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Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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(d)
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Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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5.
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The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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(a)
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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(b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: February 28, 2014
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/s/ Charlotte C. Arnold
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Charlotte C. Arnold
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Vice President, Finance and Chief Financial Officer
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Dated: February 28, 2014
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/s/ Arthur S. Przybyl
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Arthur S. Przybyl
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President and
Chief Executive Officer
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[principal executive officer]
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Dated: February 28, 2014
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/s/ Charlotte C. Arnold
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Charlotte C. Arnold
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Vice President, Finance and
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Chief Financial Officer
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[principal financial officer]
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