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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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01-0355758
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(State or other jurisdiction
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(I.R.S. Employer Identification No.)
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of incorporation or organization)
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105 Lincoln Ave., Buena, NJ
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08310
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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, $0.01 Par Value Per Share
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The NASDAQ Stock Market
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Developing, manufacturing and marketing a portfolio of generic pharmaceutical products in our own label in topical, injectable, complex and ophthalmic dosage forms; and
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•
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Managing our current contract manufacturing and formulation services business.
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Product
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Formulation
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Presentations
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Brand equivalent
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Therapeutic Classification
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Betamethasone Dipropionate (Augmented), 0.05%
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Ointment
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15g, 50g
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DIPROLENE®
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Topical Corticosteroid
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Betamethasone Dipropionate (Augmented), 0.05%
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Lotion
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30mL, 60mL
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DIPROLENE®
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Topical Corticosteroid
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Clindamycin Phosphate 1%
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Topical Solution
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30mL, 60mL
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Cleocin®
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Topical Anti-infective
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Clobetasol 0.05%
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Lotion
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2oz, 4oz
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Clobetasol
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Topical Corticosteroid
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Clobetasol Propionate 0.05%
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Gel
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15g, 30g, 60g
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Embeline®
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Topical Corticosteroid
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Clobetasol Propionate Emollient 0.05%
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Cream
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15g, 30g, 45g, 60g
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TemovateE®
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Topical Corticosteroid
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Desoximetasone 0.25%
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Ointment
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15g, 60g, 100g
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Topicort®
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Topical Corticosteroid
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Diclofenac Sodium 1.5%
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Topical Solution
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150mL
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Pennsaid®
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Topical Anti-inflammatory
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Econazole Nitrate 1%
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Cream
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15g, 30g, 85g
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Spectazole®
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Topical Anti-fungal
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Erythromycin 2%
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Gel
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30g, 60g
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Erygel®
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Topical Corticosteroid
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Erythromycin 2%
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Topical Solution
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60 mL
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Erythromycin Topical Solution 2%
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Topical Corticosteroid
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Fluocinolone Acetonide 0.01%
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Topical Solution
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60mL
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Synalar®
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Topical Corticosteroid
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Fluocinolone Acetonide 0.01%
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Cream
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15g, 60g
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Synalar®
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Topical Corticosteroid
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Fluocinolone Acetonide 0.025%
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Ointment
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15g, 60g
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Synalar®
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Topical Corticosteroid
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Fluocinolone Acetonide 0.025%
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Cream
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15g, 60g
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Synalar®
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Topical Corticosteroid
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Flurandrenolide 0.05%
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Ointment
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15g, 30g, 60g
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Cordran®
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Topical Corticosteroid
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Hydrocortisone Butyrate 0.1%
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Lotion
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118mL, 59 mL
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Locoid®
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Topical Corticosteroid
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Lidocaine 4%
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Topical Solution
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50mL
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Xylocaine®
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Topical Anesthetic
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Lidocaine 5%
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Ointment
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35.44g
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Xylocaine®
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Topical Anesthetic
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Nystatin/Triam 100,000 Nystatin units/1mg per gram
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Ointment
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15g, 30g, 60g
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Mykacet®
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Topical Anti-fungal
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Triamcinolone Acetonide 0.025%
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Lotion
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60ml
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Triamcinolone Acetonide
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Topical Corticosteroid
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Triamcinolone Acetonide 0.1%
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Ointment
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15g, 80g, 1lb jar
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Kenalog®
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Topical Corticosteroid
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Triamcinolone Acetonide 0.1%
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Lotion
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60mL
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Triamcinolone Acetonide
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Topical Corticosteroid
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Triamcinolone Acetonide 0.1%
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Cream
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15g, 30g, 80g
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Kenalog®
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Topical Corticosteroid
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Triamcinolone Acetonide 0.5%
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Ointment
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15g
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Kenalog®
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Topical Corticosteroid
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Product
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Strength
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Formulation
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Presentations
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Dossier type held by Teligent
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Therapeutic Classification
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Cefotan (Cefotetan)
®
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1g, 2g
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Injectable
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Vial
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NDA
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Antibacterial for systemic use
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Fortaz (Ceftazidime)
®
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500mg, 1g, 2g, 6g
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Injectable
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Vial, Twist Vial, Frozen Bag
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NDA
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Antibacterial for systemic use
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Zantac (Ranitidine)
®
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25mg/ml
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Injectable
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2ml, 6ml, 40ml Vials
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NDA
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Drugs for peptic ulcer and gastro-oesophageal related disorders (GORD)
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Zinacef (Cefuroxime) ™
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750mg, 1.5g, 7.5g
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Injectable
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Vial, Twist Vial
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NDA
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Antibacterial for systemic use
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Product
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Strength
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Formulation
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Presentations
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Brand equivalent
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Dossier type held by Teligent
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Therapeutic Classification
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Acetylcysteine
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200 mg/ml
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Injectable
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10ml and 30 ml vials
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Mucomyst® Parvolex®
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ANDS
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Antidote
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Atropine
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0.4 mg/ml, 0.6 mg/ml
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Injectable
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1 ml vials
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N/A
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DINA
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Antimuscarnic, antispasmodic
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Baclofen
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0.05 mg/ml, 0.5mg/ml, 2mg/ml
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Injectable
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1mL, 5mL, 20mL ampoules
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Lioresal®
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ANDS
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Muscle Relaxant
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Ibuprofen for Intravenous Infusion
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100 mg/ml
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Injectable
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8 ml vial
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Caldolor®
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NDS
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Nonsteroidal Antiinflammatory Agent
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Cyanocobalamin (2)
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1000 mcg/ml
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Injectable
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1 mL ampoule, 10 ml vial
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N/A
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DINA
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Hematopoietic
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Diazepam
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5 mg/mL
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Injectable
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2mL ampoules
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Valium®
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ANDS
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Benzodiazepine
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Dimenhydrinate
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50 mg, 250 mg
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Injectable
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1 ml ampoule, 5 ml vial
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Gravol®
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DINA
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Antihistamine
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Dobutamine (2)
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12.5 mg/ml
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Injectable
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20 mL vial
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N/A
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ANDS
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Sympathomimetic
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Epinephrine
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1 mg/ml
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Injectable
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1 ml ampoule
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Adrenalin®
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DINA
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Cardiac Stimulant
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Ergonovine Maleate
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0.25 mg/ml
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Injectable
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1 ml ampoule
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N/A
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DINA
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Oxytocic
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Fentanyl
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50 mcg/mL
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Injectable
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2mL ampoule
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Sublimaze®
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ANDS
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Opiate Anesthetic
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Furosemide
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10 mg/ml
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Injectable
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2 ml ampoule
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Lasix®
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ANDS
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Diuretic
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Gemcitabine
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10 mg, 200 mg, 1 g
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Injectable
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10 mg, 200 mg, 1 g vials
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Gemzar®
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ANDS
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Antineoplastic agent
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Gentamicin (2)
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10 mg/ml, 40 mg/ml
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Injectable
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2mL ampoule
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Garamycin®
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ANDS
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Antibiotic
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Irinotecan Hydrochloride
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20 mg/ml
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Injectable
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2 ml, 5 ml, 25 ml vials
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Camptosar®
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ANDS
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Antineoplastic agent
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Lidocaine 1%
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10 mg/mL
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Injectable
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5 ml and 10 ml polyampoule
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Xylocaine®
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DINA
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Local Anesthetic
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Lidocaine 1%
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10 mg/ml
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Injectable
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20 ml and 50 ml vials
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Xylocaine®
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DINA
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Local Anesthetic
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Lidocaine 2%
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20 mg/ml
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Injectable
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5 ml and 10 ml polyampoule
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Xylocaine®
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DINA
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Local Anesthetic
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Lidocaine 2%
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20 mg/ml
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Injectable
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20 ml and 50 ml vials
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Xylocaine®
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DINA
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Local Anesthetic
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Lidocaine 2% with epinephrine
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20 mg/ml & 0.01 mg/mL
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Injectable
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20 ml and 50 ml vials
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Xylocaine®
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DINA
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Local Anesthetic
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Lidocaine Hydrochloride Topical Solution USP 4%
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40 mg/ml
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Topical Solution
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50mL
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Xylocaine®
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DINA
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Topical Anesthetic
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Lidocaine Ointment USP 5%
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50 mg/g
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Ointment
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35g
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Xylocaine®
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DINA
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Topical Anesthetic
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Methylene Blue
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10 mg/mL
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Injectable
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5mL ampoule
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N/A
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DINA
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Antidote
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Naloxone
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0.4mg / ml
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Injectable
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1mL ampoule
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Narcan
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ANDS
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Opitate Antagonist
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Piperacillin and Tazobactam
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2g, 0.25 g, 3 g, 0.375 g, 4 g, 0.5 g
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Injectable
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2.25 g, 3.375 g, 4.5 g vials
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Tazocin®
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ANDS
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Antibacterial for systemic use
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Sodium Cloride
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0.9%
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Injectable
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10 ml vials
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N/A
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DINA
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Diluent
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Sterile Water for Injection
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100%
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Injectable
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10 ml polyampoule
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N/A
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DINA
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Diluent
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Succinylcholine Chloride
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20 mg/mL
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Injectable
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10 ml and 20 ml vials
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Quelicin®
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DINA
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Muscle Relaxant
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Product
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Strength
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Formulation
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Presentations
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Brand equivalent
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Dossier type held by Teligent
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Therapeutic Classification
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Ciprofloxacin
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0.3%
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Ophthalmic Solution
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2.5ml, 5ml, 10ml bottles
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Ciloxan ®
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ANDA
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Antibacterial for systemic use
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Betaxolol
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0.5%
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Ophthalmic Solution
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5ml, 7.5ml, 15ml bottles
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Betopic ®
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ANDA
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Beta Blocking Agent
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Phytonadione
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10mg, 1mg
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Injectable
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0.5ml, 1ml ampoules; 3cc, 6cc vials
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AquaMephyton ®
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NDA
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Hemostatic
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Amikacin Sulfate
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50mg/ml, 250mg/ml
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Injectable
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2ml, 4ml vials
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Amikacin Sulfate ®
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ANDA
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Antibacterial for systemic use
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Calcitonin Salmon
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200IU/ml
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Injectable
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2ml vials
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Miacalcin ®
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ANDA
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Anti-parathyroid Agent
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Cefotetan Disodium
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20mg/ml
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Injectable (bag)
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50ml bags
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Cefotetan ®
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NDA
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Antibacterial for systemic use
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Clindamycin Phosphate
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150mg/ml
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Injectable
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2ml, 4ml, 6ml, 60ml vials
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Cleocin ®
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ANDA
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Antibacterial for systemic use
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Dobutamine HCl
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12.5mg/ml
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Injectable
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20ml, 40ml vials
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Dobutamine HCl ®
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ANDA
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Cardiac Stimulant
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Dopamine HCl
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40mg/ml
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Injectable
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5ml, 10ml (vials and syringes)
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Dopamine HCl ®
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NDA / ANDA
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Cardiac Stimulant
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Dopamine HCl
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80mg/ml
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Injectable
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5ml, 10ml (vials, ampoules, and syringes)
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Dopamine HCl ®
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NDA / ANDA
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Cardiac Stimulant
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Dopamine HCl
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160mg/ml
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Injectable
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5ml (vials and ampoules)
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Dopamine HCl ®
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NDA / ANDA
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Cardiac Stimulant
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Droperidol
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2.5mg/ml
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Injectable
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10ml vials, 2ml and 5ml ampoules, and 2ml syringes
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Inapsine ®
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ANDA
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Anti-Psychotic
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Furosemide
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10mg/ml
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Injectable
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2ml, 4ml, 8ml, and 10ml vials, 4ml and 10ml syringes
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Furosemide ®
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ANDA
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Diuretic
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Mannitol
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USP 25%
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Injectable
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50ml (vials and syringes)
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Mannitol ®
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ANDA
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Diuretic
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Meperidine HCl
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25mg/ml, 50mg/ml, 75mg/ml, 100mg/ml
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Injectable
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1ml and 30ml vials, 1ml and 1.5ml ampoules, and 1ml syringes
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Demerol ®
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ANDA
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Systemic analgesic
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Midazolam HCl
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5mg/ml
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Injectable
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2ml syringe
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Midazolam ®
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ANDA
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Sedative
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Orphenadrine
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30 mg/mL
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Injectable
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2 mL ampule
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Orphenadrine Citrate
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ANDA
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Muscle Relaxant
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Edrophonium
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10 mg/mL
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Injectable
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1 mL ampule and 10 mL vial
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Enlon®
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NDA
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Acetylcholinesterase inhibitor
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MVI-12
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N/A
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Injectable
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10 mL ampules and 5 mL vials
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N/A
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NDA
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Systemic multivitamin
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Naloxone HCl
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0.4 mg/mL, 1 mg/mL
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Injectable
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1 mL 5 mLand 10 mL vials
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N/A
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ANDA
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Opitate Antagonist
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Naloxone HCl (preservative free)
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0.4 mg/mL
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Injectable
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1 mL vials
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N/A
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ANDA
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Opitate Antagonist
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Tobramycin Sulfate
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10 mg/mL, 40 mg/mL
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Injectable
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2 mLand 35 mL vials
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N/A
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ANDA
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Antibacterial for systemic use
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Nalbuphine
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10 mg/mL and 20 mg/mL
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Injectable
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1 mL and 10 mL vials
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Nubain®
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ANDA
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Systemic analgesic
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•
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New Drug Application — An NDA is filed when approval is sought to market a newly developed branded product and, in certain instances, for a new dosage form, a new delivery system or a new indication for a previously approved drug.
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Abbreviated New Drug Application — An ANDA is filed when approval is sought to market a generic equivalent of a drug product previously approved under an NDA and listed in the FDA’s Orange Book or for a new dosage strength for a drug previously approved under an ANDA.
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Safety – Ensure that industry participants, foreign or domestic, are held to consistent quality standards and are inspected with parity using a risk-based approach.
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Access – Expedite the availability of generic drugs by bringing greater predictability to the review times for abbreviated new drug applications, amendments and supplements and improving timeliness in the review process.
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Transparency – Enhance FDA’s visibility into the complex global supply environment by requiring the identification of facilities involved in the manufacture of generic drugs and associated APIs, and improve FDA’s communications and feedback with industry.
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the original manufacturers of the brand-name equivalents of our generic products; and
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other generic drug manufacturers.
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pursuing new patents for existing products that may be granted just before the expiration of earlier patents, which could extend patent protection for additional years or otherwise delay the launch of generics;
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selling the brand product as an “authorized generic,” either by the brand company directly, through an affiliate or by a marketing partner;
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using the Citizen Petition process to request amendments to FDA standards or otherwise delay generic drug approvals;
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seeking changes to the U.S. Pharmacopeia, an FDA, and industry recognized compendia of drug standards;
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attaching patent extension amendments to non-related federal legislation;
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engaging in state-by-state initiatives to enact legislation that restricts the substitution of some generic drugs, which could have an impact on products that we are developing; and
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seeking patents on methods of manufacturing certain active pharmaceutical ingredients.
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the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs, such as Medicare and Medicaid. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;
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the federal False Claims Act, or FCA, which imposes civil liability and criminal fines on individuals or entities that knowingly submit, or cause to be submitted, false or fraudulent claims for payment to the government. The FCA also allows private individuals to bring a suit on behalf of the government against an individual or entity for violations of the FCA. These suits, also known as qui tam actions, may be brought by, with only a few exceptions, any private citizen who believes that he has material information of a false claim that has not yet been previously disclosed. These suits have increased significantly in recent years because the FCA allows an individual to share in any amounts paid to the federal government in fines or settlement as a result of a successful qui tam action;
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federal criminal laws that prohibit executing a scheme to defraud any federal healthcare benefit program or making false statements relating to healthcare matters;
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the federal Physician Payment Sunshine Act, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the government information related to payments or other “transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and applicable manufacturers and group purchasing organizations to report annually ownership and investment interests held by physicians (as defined above) and their immediate family members and payments or other “transfers of value” to such physician owners and their immediate family members;
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the Federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH Act, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information;
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the Foreign Corrupt Practices Act (FCPA) including its anti-bribery provisions, which make it unlawful for certain classes of persons and entities to make payments to foreign government officials to assist in obtaining or retaining business; and
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analogous state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers; state laws that require
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•
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the availability of alternative products from our competitors;
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the price of our products relative to that of our competitors;
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the timing of our market entry;
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the ability to market our products effectively to the different levels in the distribution chain;
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other competitor actions; and
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the continued acceptance of and/or reimbursement for our products by government and private formularies and/or third party payors.
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•
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the pending patent applications we have filed or may file, or to which we have exclusive rights, may not result in issued patents, or may take longer than we expect to result in issued patents;
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changes in U.S. patent laws may adversely affect our ability to obtain or maintain our patent protection;
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we may be subject to interference proceedings;
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the claims of any patents that are issued may not provide meaningful protection;
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we may not be able to develop additional proprietary technologies that are patentable;
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the patents licensed or issued to us or our collaborators may not provide a competitive advantage;
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other companies may challenge patents licensed or issued to us or our collaborators;
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other companies may independently develop similar or alternative technologies, or duplicate our technology;
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other companies may design around technologies we have licensed or developed; and
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enforcement of patents is complex, uncertain and expensive.
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pay damages in the form of lost profits and/or a reasonable royalty for any infringement;
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pay substantial damages (potentially treble damages in the U.S. if any such infringement is found to be willful);
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pay attorney fees of a prevailing party, if the case is found to be exceptional;
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cease the manufacture, use or sale of the infringing offerings or processes;
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discontinue the use of the infringing technology;
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expend significant resources to design around patented technology and develop non-infringing technology; and
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license patented technology from the third party claiming infringement, which license may not be available on commercially reasonable terms, or may not be available at all.
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additional costs that we may need to incur in order to return the products to the market and to comply with regulatory requirements;
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difficulties in coordinating research and development activities;
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uncertainties in the business relationships with our customers and suppliers; and
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•
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lack of previous experiences in manufacturing, commercializing, and distributing products in therapeutic areas outside of the topical generic pharmaceutical market and in markets outside of the United States.
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•
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the availability of alternative products from our competitors;
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the price of our products relative to that of our competitors;
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the effectiveness of our marketing relative to that of our competitors;
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the timing of our market entry;
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the ability to market our products effectively to the retail level; and
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the acceptance of our products by government and private formularies.
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diversion of management time and focus from operating our business to addressing acquisition and/or product integration challenges;
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coordination of research and development and sales and marketing functions;
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retention of key employees from the acquired company;
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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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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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unanticipated write-offs or charges; and
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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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•
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publicity regarding actual or potential clinical results relating to products under development by our competitors or us;
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•
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delay or failure in initiating, completing or analyzing nonclinical or clinical trials or the unsatisfactory design or results of these trials;
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•
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achievement or rejection of regulatory approvals by our competitors or us;
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•
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announcements of technological innovations or new commercial products by our competitors or us;
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•
|
developments concerning proprietary rights, including patents;
|
•
|
developments concerning our collaborations;
|
•
|
regulatory developments in the U.S. and foreign countries;
|
•
|
economic or other crises in the markets in which we compete, and other external factors;
|
•
|
stock market price and volume fluctuations of other publicly traded companies and, in particular, those that are in the cosmetic, pharmaceutical and consumer products industry;
|
•
|
actual or anticipated sales of our common stock, including sales by our directors, officers or significant stockholders;
|
•
|
period-to-period fluctuations in our revenues and other results of operations; and
|
•
|
speculation about our business in the press or the investment community.
|
•
|
make it difficult for us to satisfy our obligations with respect to our outstanding and other future debt obligations;
|
•
|
increase our vulnerability to general adverse economic conditions or a downturn in the industries in which we operate;
|
•
|
impair our ability to obtain additional financing in the future for working capital, investments, acquisitions and other general corporate purposes;
|
•
|
require us to dedicate a substantial portion of our cash flows to the payment to our financing sources, thereby reducing the availability of our cash flows to fund working capital, investments, acquisitions and other general corporate purposes; and
|
•
|
place us at a disadvantage compared to our competitors.
|
|
|
As of and For the Years Ended December 31,
|
||||||||||||||||||
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
||||||||||
(In thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Revenues
|
|
$
|
67,251
|
|
|
$
|
66,881
|
|
|
$
|
44,250
|
|
|
$
|
33,740
|
|
|
$
|
18,224
|
|
Gross profit
|
|
27,372
|
|
|
34,687
|
|
|
21,315
|
|
|
16,972
|
|
|
6,145
|
|
|||||
Operating income (loss)
|
|
(11,797
|
)
|
|
2,542
|
|
|
(3,192
|
)
|
|
3,906
|
|
|
(82
|
)
|
|||||
Interest and other non-operating income (expense)
|
|
(3,479
|
)
|
|
(14,240
|
)
|
|
9,895
|
|
|
1,518
|
|
|
(199
|
)
|
|||||
Foreign currency exchange gain (loss)
|
|
7,719
|
|
|
(936
|
)
|
|
109
|
|
|
—
|
|
|
—
|
|
|||||
Pretax income (loss)
|
|
(15,276
|
)
|
|
(11,698
|
)
|
|
6,703
|
|
|
5,424
|
|
|
(281
|
)
|
|||||
Income tax provision (benefit)
|
|
(85
|
)
|
|
287
|
|
|
35
|
|
|
173
|
|
|
(197
|
)
|
|||||
Net income (loss)
|
|
$
|
(15,191
|
)
|
|
$
|
(11,985
|
)
|
|
$
|
6,668
|
|
|
$
|
5,251
|
|
|
$
|
(84
|
)
|
Preferred stock dividend
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,308
|
)
|
|||||
Net income (loss) attributable to common stockholders
|
|
$
|
(15,191
|
)
|
|
$
|
(11,985
|
)
|
|
$
|
6,668
|
|
|
$
|
5,251
|
|
|
(1,392
|
)
|
|
Weighted average shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Basic
|
|
53,324
|
|
|
53,078
|
|
|
52,873
|
|
|
49,818
|
|
|
43,518
|
|
|||||
Diluted
|
|
53,324
|
|
|
53,078
|
|
|
67,112
|
|
|
64,207
|
|
|
43,518
|
|
|||||
PER SHARE:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Net income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Basic
|
|
(0.28
|
)
|
|
(0.23
|
)
|
|
0.13
|
|
|
0.11
|
|
|
(0.03
|
)
|
|||||
Diluted
|
|
(0.28
|
)
|
|
(0.23
|
)
|
|
(0.07
|
)
|
|
0.09
|
|
|
(0.03
|
)
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
BALANCE SHEET DATA:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Current assets
|
|
$
|
64,532
|
|
|
$
|
103,296
|
|
|
$
|
116,801
|
|
|
$
|
177,218
|
|
|
$
|
10,558
|
|
Net property, plant & equipment
|
|
68,355
|
|
|
26,215
|
|
|
8,706
|
|
|
3,262
|
|
|
2,623
|
|
|||||
Total assets
|
|
189,986
|
|
|
183,226
|
|
|
184,762
|
|
|
197,078
|
|
|
15,427
|
|
|||||
Current liabilities
|
|
24,097
|
|
|
14,963
|
|
|
10,768
|
|
|
13,002
|
|
|
5,221
|
|
|||||
Long-term obligations, less current installments
|
|
121,136
|
|
|
111,596
|
|
|
107,235
|
|
|
144,942
|
|
|
3,015
|
|
|||||
Shareholders’ equity
|
|
44,753
|
|
|
56,667
|
|
|
66,759
|
|
|
39,134
|
|
|
7,191
|
|
|||||
CASH FLOW DATA:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Cash provided by (used in) operating activities
|
|
$
|
400
|
|
|
$
|
(798
|
)
|
|
$
|
(15,513
|
)
|
|
$
|
(3,891
|
)
|
|
$
|
(618
|
)
|
Cash used in investing activities
|
|
(40,429
|
)
|
|
(20,076
|
)
|
|
(53,068
|
)
|
|
(3,792
|
)
|
|
(2,113
|
)
|
|||||
Cash provided by (used in) financing activities
|
|
269
|
|
|
(10
|
)
|
|
(3,111
|
)
|
|
164,465
|
|
|
2,296
|
|
|||||
Increase/(Decrease) in cash and cash equivalents
|
|
(39,760
|
)
|
|
(20,884
|
)
|
|
(71,692
|
)
|
|
156,782
|
|
|
(435
|
)
|
•
|
Developing, manufacturing and marketing a portfolio of generic pharmaceutical products in our own label in topical, injectable, complex and ophthalmic dosage forms; and
|
•
|
Managing our current contract manufacturing and formulation services business.
|
|
|
Year Ended December 31,
|
|
Increase/(Decrease)
|
|||||||||||
Components of Revenue:
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
Product sales, net
|
|
$
|
66,999
|
|
|
$
|
65,904
|
|
|
$
|
1,095
|
|
|
2
|
%
|
Research and development services and other income
|
|
252
|
|
|
977
|
|
|
(725
|
)
|
|
(74
|
)%
|
|||
Total Revenues
|
|
$
|
67,251
|
|
|
$
|
66,881
|
|
|
$
|
370
|
|
|
1
|
%
|
|
|
Year Ended December 31,
|
|
Increase/(Decrease)
|
|||||||||||
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
Cost of revenues
|
|
$
|
39,879
|
|
|
$
|
32,194
|
|
|
$
|
7,685
|
|
|
24
|
%
|
Selling, general and administrative
|
|
19,904
|
|
|
15,005
|
|
|
4,899
|
|
|
33
|
%
|
|||
Product development and research
|
|
19,265
|
|
|
17,140
|
|
|
2,125
|
|
|
12
|
%
|
|||
Totals costs and expenditures
|
|
$
|
79,048
|
|
|
$
|
64,339
|
|
|
$
|
14,709
|
|
|
23
|
%
|
|
|
Year Ended December 31,
|
|
Increase/(Decrease)
|
|||||||||||
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
Interest and other expense, net
|
|
$
|
(11,198
|
)
|
|
$
|
(13,304
|
)
|
|
$
|
2,106
|
|
|
16
|
%
|
Foreign exchange (loss) / gain
|
|
$
|
7,719
|
|
|
$
|
(936
|
)
|
|
$
|
8,655
|
|
|
100
|
%
|
|
|
Year Ended December 31,
|
|
Increase/(Decrease)
|
|||||||||||
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
Net loss attributable to common stockholders
|
|
$
|
(15,191
|
)
|
|
$
|
(11,985
|
)
|
|
$
|
(3,206
|
)
|
|
27
|
%
|
Basic loss per share
|
|
$
|
(0.28
|
)
|
|
$
|
(0.23
|
)
|
|
$
|
(0.05
|
)
|
|
22
|
%
|
Diluted loss per share
|
|
$
|
(0.28
|
)
|
|
$
|
(0.23
|
)
|
|
$
|
(0.05
|
)
|
|
22
|
%
|
|
|
Year Ended December 31,
|
|
Increase/(Decrease)
|
|||||||||||
Components of Revenue:
|
|
2016
|
|
2015
|
|
$
|
|
%
|
|||||||
Product sales, net
|
|
$
|
65,904
|
|
|
$
|
43,497
|
|
|
$
|
22,407
|
|
|
52
|
%
|
Research and development services and other income
|
|
977
|
|
|
753
|
|
|
224
|
|
|
30
|
%
|
|||
Total Revenues
|
|
$
|
66,881
|
|
|
$
|
44,250
|
|
|
$
|
22,631
|
|
|
51
|
%
|
|
|
Year Ended December 31,
|
|
Increase/(Decrease)
|
|||||||||||
|
|
2016
|
|
2015
|
|
$
|
|
%
|
|||||||
Cost of revenues
|
|
$
|
32,194
|
|
|
$
|
22,935
|
|
|
$
|
9,259
|
|
|
40
|
%
|
Selling, general and administrative
|
|
15,005
|
|
|
11,336
|
|
|
3,669
|
|
|
32
|
%
|
|||
Product development and research
|
|
17,140
|
|
|
13,171
|
|
|
3,969
|
|
|
30
|
%
|
|||
Totals costs and expenditures
|
|
$
|
64,339
|
|
|
$
|
47,442
|
|
|
$
|
16,897
|
|
|
36
|
%
|
|
|
Year Ended December 31,
|
|
Increase/(Decrease)
|
|||||||||||
|
|
2016
|
|
2015
|
|
$
|
|
%
|
|||||||
Interest and other expense, net
|
|
$
|
(13,304
|
)
|
|
$
|
(13,358
|
)
|
|
$
|
54
|
|
|
—
|
%
|
Foreign exchange (loss) / gain
|
|
$
|
(936
|
)
|
|
$
|
109
|
|
|
$
|
(1,045
|
)
|
|
100
|
%
|
Change in the fair value of derivative liability
|
|
$
|
—
|
|
|
$
|
23,144
|
|
|
$
|
(23,144
|
)
|
|
(100
|
)%
|
|
|
Year Ended December 31,
|
|
Increase/(Decrease)
|
|||||||||||
|
|
2016
|
|
2015
|
|
$
|
|
%
|
|||||||
Net (loss) income attributable to common stockholders
|
|
$
|
(11,985
|
)
|
|
$
|
6,668
|
|
|
$
|
(18,653
|
)
|
|
(280
|
)%
|
Basic (loss) earnings per share
|
|
$
|
(0.23
|
)
|
|
$
|
0.13
|
|
|
$
|
(0.36
|
)
|
|
(277
|
)%
|
Diluted loss per share
|
|
$
|
(0.23
|
)
|
|
$
|
(0.07
|
)
|
|
$
|
(0.16
|
)
|
|
229
|
%
|
|
|
Payments Due by Period
(in thousands) |
||||||||||||||||||
Contractual Obligations
|
|
Total
|
|
Less than 1 Year
|
|
1-3 Years
|
|
3-5 Years
|
|
More than 5
Years |
||||||||||
Convertible Senior Notes
|
|
$
|
143,750
|
|
|
$
|
—
|
|
|
$
|
143,750
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating Lease
|
|
2,513
|
|
|
491
|
|
|
877
|
|
|
730
|
|
|
415
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Total
|
|
$
|
146,263
|
|
|
$
|
491
|
|
|
$
|
144,627
|
|
|
$
|
730
|
|
|
$
|
415
|
|
•
|
The absence of a formal policy to assess the adequacy of the design and operating effectiveness of controls related to the Company’s key ERP third party service provider.
|
•
|
The absence of or breakdown of Information Security, Change Management and System Development Life Cycle controls related to the company’s key financial systems.
|
•
|
Hiring new team members and engaging external resources with significant prior experience with systems similar to the Company's new ERP system to provide additional capacity, analytical and functional capabilities, and cross-training.
|
•
|
Implementing business process improvements, that are anticipated to both strengthen controls governing management review and approvals and enable a more efficient and effective month end close.
|
•
|
Conducting regular reviews of all information system access to validate that access is appropriate and appropriate segregation of duties exist.
|
•
|
Recruiting a new senior leader in one of its foreign affiliates who, among other responsibilities, will ensure customer contract terms are reviewed with key members of the Finance Department on a timely basis to ensure customer price concessions are reflected appropriately in the financial records.
|
•
|
Establishing formal policies and procedures for the accounting and internal audit function.
|
•
|
Developing policies and procedures addressing the internal control framework of the Company’s ERP service provider.
|
(a)
|
The following documents are filed as part of this Annual Report on Form 10-K:
|
|
|
(a)(1)
|
See “Index to Consolidated Financial Statements and Financial Statement Schedules” at Item 8 to this Annual Report on Form 10-K.
|
|
|
(a)(2)
|
Other financial statement schedules have not been included because they are not applicable or the information is included in the financial statements or notes thereto.
|
|
|
(a)(3)
|
The following is a list of exhibits filed as part of this Annual Report on Form 10-K.
|
|
|
Exhibits
|
|
|
|
(3.1)
|
|
|
|
(3.2)
|
|
|
|
(4.1)
|
|
|
|
(4.2)
|
|
|
|
(10.1)#
|
|
|
|
(10.2)#
|
|
|
|
(10.3)#
|
|
|
|
(10.4)#
|
|
|
|
(10.5)#
|
|
|
|
(10.6)#
|
|
|
|
(10.7)#
|
|
|
|
(10.8)#
|
|
|
(10.9)#
|
|
|
|
(10.10)#
|
|
|
|
(10.11)+
|
|
|
|
(10.12)
|
|
|
|
(10.13)
|
|
|
|
(10.14)+
|
|
|
|
(10.15)
|
|
|
|
(10.16)
|
|
|
|
(10.17)
|
|
|
|
(10.18)
|
|
|
|
(10.19)
|
|
|
|
(10.20)+
|
|
|
|
(10.21)
|
|
|
|
(10.22)
|
|
|
(10.23)
|
|
|
|
(10.24)
|
|
|
|
(10.25)
|
|
|
|
(10.26)
|
|
|
|
(10.27)
|
|
|
|
(10.28)
|
|
|
|
(10.29)
|
|
|
|
(10.30)#
|
|
|
|
(10.31)#
|
|
|
|
(10.32)#
|
|
|
|
(21)
|
|
|
|
(23.1)*
|
|
|
|
(31.1)*
|
|
|
|
(31.2)*
|
|
|
|
(32.1)*
|
|
|
|
(101)*
|
The following financial information from this Annual Report on Form 10-K for the year ended December 31, 2017, formatted in XBRL (Extensible Business Reporting Language) and furnished electronically herewith: (i) the Consolidated Statements of Operations; (ii) the Consolidated Balance Sheets; (iii) the Consolidated Statements of Cash Flows; and (iv) the Notes to Consolidated Financial Statements, tagged as blocks of text.
|
|
Teligent, Inc.
|
|
|
|
|
|
By:
|
/s/ Jason Grenfell-Gardner
|
|
|
Jason Grenfell-Gardner
|
|
|
President and Chief Executive Officer
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ Jason Grenfell-Gardner
|
|
Director, President and Chief Executive Officer
|
|
March 19, 2018
|
Jason Grenfell-Gardner
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
/s/ Damian Finio
|
|
Chief Financial Officer
|
|
March 19, 2018
|
Damian Finio
|
|
(Principal Financial Officer)
|
|
|
|
|
|
|
|
/s/ Steven Koehler
|
|
Director
|
|
March 19, 2018
|
Steven Koehler
|
|
|
|
|
|
|
|
|
|
/s/ James Gale
|
|
Director
|
|
March 19, 2018
|
James Gale
|
|
|
|
|
|
|
|
|
|
/s/ Bhaskar Chaudhuri
|
|
Director
|
|
March 19, 2018
|
Bhaskar Chaudhuri
|
|
|
|
|
|
|
|
|
|
/s/ John Celentano
|
|
Director
|
|
March 19, 2018
|
John Celentano
|
|
|
|
|
|
|
|
|
|
/s/ Carole Ben-Maimon
|
|
Director
|
|
March 19, 2018
|
Carole Ben-Maimon
|
|
|
|
|
|
|
|
|
|
/s/ Thomas Sabatino
|
|
Director
|
|
March 19, 2018
|
Thomas Sabatino
|
|
|
|
|
|
|
December 31, 2017
|
|
December 31, 2016
|
||||
ASSETS
|
|
|
|
|
|
|
||
Current assets:
|
|
|
|
|
|
|
||
Cash and cash equivalents
|
|
$
|
26,692
|
|
|
$
|
66,006
|
|
Accounts receivable, net
|
|
18,143
|
|
|
21,735
|
|
||
Inventories
|
|
16,075
|
|
|
12,708
|
|
||
Prepaid expenses and other receivables
|
|
3,622
|
|
|
2,847
|
|
||
Total current assets
|
|
64,532
|
|
|
103,296
|
|
||
|
|
|
|
|
||||
Property, plant and equipment, net
|
|
68,355
|
|
|
26,215
|
|
||
Intangible assets, net
|
|
56,017
|
|
|
52,465
|
|
||
Goodwill
|
|
471
|
|
|
446
|
|
||
Other
|
|
611
|
|
|
804
|
|
||
Total assets
|
|
$
|
189,986
|
|
|
$
|
183,226
|
|
|
|
|
|
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
|
||
|
|
|
|
|
||||
Current liabilities:
|
|
|
|
|
|
|
||
Accounts payable
|
|
$
|
10,595
|
|
|
$
|
4,614
|
|
Accrued expenses
|
|
13,502
|
|
|
10,349
|
|
||
Total current liabilities
|
|
24,097
|
|
|
14,963
|
|
||
|
|
|
|
|
||||
Convertible 3.75% senior notes, net of debt discount and debt issuance costs (face of $143,750)
|
|
120,977
|
|
|
111,391
|
|
||
Deferred tax liability
|
|
159
|
|
|
205
|
|
||
Total liabilities
|
|
145,233
|
|
|
126,559
|
|
||
|
|
|
|
|
||||
Stockholders’ equity:
|
|
|
|
|
|
|
||
Common stock, $0.01 par value, 100,000,000 shares authorized; 53,400,281 and 53,148,441 shares issued and outstanding as of December 31, 2017 and December 31, 2016, respectively
|
|
554
|
|
|
551
|
|
||
Additional paid-in capital
|
|
106,312
|
|
|
102,624
|
|
||
Accumulated deficit
|
|
(60,094
|
)
|
|
(44,903
|
)
|
||
Accumulated other comprehensive loss, net of taxes
|
|
(2,019
|
)
|
|
(1,605
|
)
|
||
Total stockholders’ equity
|
|
44,753
|
|
|
56,667
|
|
||
Total liabilities and stockholders’ equity
|
|
$
|
189,986
|
|
|
$
|
183,226
|
|
|
|
2017
|
|
2016
|
|
2015
|
||||||
Components of Revenue:
|
|
|
|
|
|
|
|
|
|
|||
Product sales, net
|
|
$
|
66,999
|
|
|
$
|
65,904
|
|
|
$
|
43,497
|
|
Research and development services and other income
|
|
252
|
|
|
977
|
|
|
753
|
|
|||
Total revenues
|
|
67,251
|
|
|
66,881
|
|
|
44,250
|
|
|||
|
|
|
|
|
|
|
||||||
Costs and Expenses:
|
|
|
|
|
|
|
|
|
|
|||
Cost of revenues
|
|
39,879
|
|
|
32,194
|
|
|
22,935
|
|
|||
Selling, general and administrative expenses
|
|
19,904
|
|
|
15,005
|
|
|
11,336
|
|
|||
Product development and research expenses
|
|
19,265
|
|
|
17,140
|
|
|
13,171
|
|
|||
Total costs and expenses
|
|
79,048
|
|
|
64,339
|
|
|
47,442
|
|
|||
Operating (loss) income
|
|
(11,797
|
)
|
|
2,542
|
|
|
(3,192
|
)
|
|||
|
|
|
|
|
|
|
||||||
Other Income (Expense):
|
|
|
|
|
|
|
|
|
|
|||
Change in the fair value of derivative liability
|
|
—
|
|
|
—
|
|
|
23,144
|
|
|||
Foreign currency exchange gain (loss)
|
|
7,719
|
|
|
(936
|
)
|
|
109
|
|
|||
Interest and other expense, net
|
|
(11,198
|
)
|
|
(13,304
|
)
|
|
(13,358
|
)
|
|||
(Loss) income before income tax expense
|
|
(15,276
|
)
|
|
(11,698
|
)
|
|
6,703
|
|
|||
|
|
|
|
|
|
|
||||||
Income tax (benefit) expense
|
|
(85
|
)
|
|
287
|
|
|
35
|
|
|||
|
|
|
|
|
|
|
||||||
Net (loss) income attributable to common stockholders
|
|
$
|
(15,191
|
)
|
|
$
|
(11,985
|
)
|
|
$
|
6,668
|
|
|
|
|
|
|
|
|
||||||
Basic (loss) earnings per share
|
|
$
|
(0.28
|
)
|
|
$
|
(0.23
|
)
|
|
$
|
0.13
|
|
Diluted (loss) earnings per share
|
|
$
|
(0.28
|
)
|
|
$
|
(0.23
|
)
|
|
$
|
(0.07
|
)
|
|
|
|
|
|
|
|
||||||
Weighted average shares of common stock outstanding:
|
|
|
|
|
|
|
|
|
|
|||
Basic
|
|
53,323,954
|
|
|
53,078,158
|
|
|
52,872,814
|
|
|||
Diluted
|
|
53,323,954
|
|
|
53,078,158
|
|
|
67,111,995
|
|
|
|
2017
|
|
2016
|
|
2015
|
||||||
Net income (loss)
|
|
$
|
(15,191
|
)
|
|
$
|
(11,985
|
)
|
|
$
|
6,668
|
|
|
|
|
|
|
|
|
||||||
Other comprehensive loss, net of tax
|
|
|
|
|
|
|
|
|
|
|||
Foreign currency translation adjustment
|
|
(414
|
)
|
|
(1,475
|
)
|
|
(130
|
)
|
|||
Other comprehensive loss
|
|
(414
|
)
|
|
(1,475
|
)
|
|
(130
|
)
|
|||
|
|
|
|
|
|
|
||||||
Comprehensive income (loss)
|
|
$
|
(15,605
|
)
|
|
$
|
(13,460
|
)
|
|
$
|
6,538
|
|
|
|
2017
|
|
2016
|
|
2015
|
||||||
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|||
Net income (loss)
|
|
$
|
(15,191
|
)
|
|
$
|
(11,985
|
)
|
|
$
|
6,668
|
|
Reconciliation of net income (loss) to net cash provided by (used in) operating activities:
|
|
|
|
|
|
|
|
|
|
|||
Depreciation and amortization of fixed assets
|
|
1,711
|
|
|
946
|
|
|
560
|
|
|||
Amortization of license fee
|
|
—
|
|
|
—
|
|
|
100
|
|
|||
Provision for write down of inventory
|
|
2,132
|
|
|
1,400
|
|
|
50
|
|
|||
Provision for bad debt
|
|
1,767
|
|
|
327
|
|
|
—
|
|
|||
Issuance of stock to consultant
|
|
—
|
|
|
189
|
|
|
—
|
|
|||
Stock based compensation
|
|
3,295
|
|
|
2,999
|
|
|
2,273
|
|
|||
Amortization of debt issuance costs
|
|
943
|
|
|
828
|
|
|
1,132
|
|
|||
Amortization of intangibles
|
|
2,930
|
|
|
2,833
|
|
|
514
|
|
|||
Foreign currency exchange loss (gain)
|
|
(7,719
|
)
|
|
936
|
|
|
(109
|
)
|
|||
Amortization of debt discount on convertible 3.75% senior notes
|
|
8,643
|
|
|
7,599
|
|
|
6,680
|
|
|||
Change in the fair value of derivative liability
|
|
—
|
|
|
—
|
|
|
(23,144
|
)
|
|||
Loss on disposal of property/impairment
|
|
113
|
|
|
16
|
|
|
—
|
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|||
Accounts receivable
|
|
1,894
|
|
|
(8,008
|
)
|
|
1,250
|
|
|||
Inventories
|
|
(5,275
|
)
|
|
(5,042
|
)
|
|
(3,578
|
)
|
|||
Prepaid expenses and other current receivables
|
|
(748
|
)
|
|
3,427
|
|
|
(5,408
|
)
|
|||
Other assets
|
|
194
|
|
|
316
|
|
|
(14
|
)
|
|||
Accounts payable and accrued expenses
|
|
5,711
|
|
|
2,897
|
|
|
(2,849
|
)
|
|||
Deferred income
|
|
—
|
|
|
(476
|
)
|
|
362
|
|
|||
|
|
|
|
|
|
|
||||||
Net cash provided by (used in) operating activities
|
|
400
|
|
|
(798
|
)
|
|
(15,513
|
)
|
|||
|
|
|
|
|
|
|
||||||
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|||
Capital expenditures
|
|
(40,429
|
)
|
|
(16,655
|
)
|
|
(5,998
|
)
|
|||
Acquisition of product rights and other related assets
|
|
—
|
|
|
—
|
|
|
(35,418
|
)
|
|||
Product acquisition costs, net
|
|
—
|
|
|
(3,421
|
)
|
|
(11,652
|
)
|
|||
Net cash used in investing activities
|
|
(40,429
|
)
|
|
(20,076
|
)
|
|
(53,068
|
)
|
|||
|
|
|
|
|
|
|
||||||
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|||
Proceeds from issuance of stock, net
|
|
—
|
|
|
—
|
|
|
(3
|
)
|
|||
Principal payments on note payable, bank
|
|
—
|
|
|
—
|
|
|
(3,160
|
)
|
|||
Proceeds from exercise of common stock options and warrants
|
|
269
|
|
|
96
|
|
|
165
|
|
|||
Principal payments on capital lease obligations
|
|
—
|
|
|
(70
|
)
|
|
(132
|
)
|
|||
Payment (recovery) from stockholder, net
|
|
—
|
|
|
(36
|
)
|
|
19
|
|
|||
Net cash provided by (used in) financing activities
|
|
269
|
|
|
(10
|
)
|
|
(3,111
|
)
|
|||
|
|
|
|
|
|
|
||||||
Effect of exchange rate on cash and cash equivalents
|
|
446
|
|
|
(301
|
)
|
|
—
|
|
|||
Net decrease in cash and cash equivalents
|
|
(39,760
|
)
|
|
(20,884
|
)
|
|
(71,692
|
)
|
|||
Cash and cash equivalents at beginning of year
|
|
66,006
|
|
|
87,191
|
|
|
158,883
|
|
|||
|
|
|
|
|
|
|
||||||
Cash and cash equivalents at end of year
|
|
$
|
26,692
|
|
|
$
|
66,006
|
|
|
$
|
87,191
|
|
|
|
|
|
|
|
|
||||||
Supplemental Cash flow information:
|
|
|
|
|
|
|
|
|
|
|||
Cash payments for interest
|
|
$
|
5,391
|
|
|
$
|
5,393
|
|
|
$
|
5,517
|
|
Cash payments for income taxes
|
|
126
|
|
|
113
|
|
|
123
|
|
|||
|
|
|
|
|
|
|
||||||
Non cash investing and financing transactions:
|
|
|
|
|
|
|
|
|
|
|||
Reclassification of derivative liability to equity
|
|
—
|
|
|
—
|
|
|
18,256
|
|
|||
Acquisition of capital expenditures in accounts payable and accrued expenses
|
|
3,186
|
|
|
1,805
|
|
|
—
|
|
|||
Capitalized stock compensation in capital expenditures
|
|
127
|
|
|
91
|
|
|
—
|
|
|||
Issuance of stock to consultant
|
|
—
|
|
|
189
|
|
|
31
|
|
|||
Issuance of restricted stock
|
|
—
|
|
|
—
|
|
|
347
|
|
|
|
Series A
Convertible |
|
Series C
Convertible |
|
|
|
|
|
Additional
|
|
|
|
Accumulated
Other |
|
Total
|
||||||||||||||||||||
|
|
Preferred Stock
|
|
Preferred Stock
|
|
Common Stock
|
|
Paid-In
|
|
Accumulated
|
|
Comprehensive
|
|
Stockholders’
|
||||||||||||||||||||||
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Capital
|
|
Deficit
|
|
Loss
|
|
Equity
|
||||||||||||||||
Balance, December 31, 2014
|
|
—
|
|
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
52,819,787
|
|
|
$
|
548
|
|
|
$
|
78,172
|
|
|
$
|
(39,586
|
)
|
|
$
|
—
|
|
|
$
|
39,134
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Issuance of stock pursuant to a public offering, net of associated fees of $1,868
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
—
|
|
|||||||||
Issuance of stock to consultant
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,000
|
|
|
|
|
|
31
|
|
|
|
|
|
|
|
|
31
|
|
||||||
Stock based compensation expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,273
|
|
|
|
|
|
|
|
|
2,273
|
|
||||||
Stock warrants exercised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
67,636
|
|
|
|
|
82
|
|
|
|
|
|
|
|
|
82
|
|
|||||||
Stock options exercised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
75,766
|
|
|
1
|
|
|
82
|
|
|
|
|
|
|
|
|
83
|
|
||||||
Issuance of restricted stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32,500
|
|
|
|
|
346
|
|
|
|
|
|
|
|
|
346
|
|
|||||||
Reclassification of derivative liability to equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,256
|
|
|
|
|
|
|
|
|
18,256
|
|
||||||
Recovery from stockholder, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
19
|
|
|
|
|
|
|
19
|
|
||||||||||||||
Costs related to stock issuance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3
|
)
|
|
|
|
|
|
(3
|
)
|
||||||||||||||
Cumulative translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(130
|
)
|
|
(130
|
)
|
||||||||||||||
Net income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
6,668
|
|
|
—
|
|
|
6,668
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Balance, December 31, 2015
|
|
—
|
|
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
53,000,689
|
|
|
$
|
549
|
|
|
$
|
99,258
|
|
|
$
|
(32,918
|
)
|
|
$
|
(130
|
)
|
|
$
|
66,759
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Issuance of stock to consultant
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,000
|
|
|
|
|
189
|
|
|
|
|
|
|
|
|
189
|
|
|||||||
Stock based compensation expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,090
|
|
|
|
|
|
|
|
|
3,090
|
|
|||||||
Stock warrants exercised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
—
|
|
||||||||
Stock options exercised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
61,834
|
|
|
1
|
|
|
95
|
|
|
|
|
|
|
|
|
96
|
|
||||||
Issuance of stock for vested restricted stock units
|
|
|
|
|
|
|
|
|
|
|
|
|
|
60,918
|
|
|
1
|
|
|
|
|
|
|
|
|
|
|
1
|
|
|||||||
Recovery from stockholder, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(36
|
)
|
|
|
|
|
|
(36
|
)
|
||||||||||||||
Tax benefit related to stock options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
28
|
|
|
|
|
|
|
28
|
|
||||||||||||||
Cumulative translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,475
|
)
|
|
(1,475
|
)
|
||||||||||||||
Net loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(11,985
|
)
|
|
—
|
|
|
(11,985
|
)
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Balance, December 31, 2016
|
|
—
|
|
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
53,148,441
|
|
|
$
|
551
|
|
|
$
|
102,624
|
|
|
$
|
(44,903
|
)
|
|
$
|
(1,605
|
)
|
|
$
|
56,667
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Issuance of stock to consultant
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
—
|
|
|||||||||
Stock based compensation expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,422
|
|
|
|
|
|
|
|
|
3,422
|
|
||||||||
Stock options exercised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
171,566
|
|
|
2
|
|
|
267
|
|
|
|
|
|
|
|
|
269
|
|
||||||
Issuance of stock for vested restricted stock units
|
|
|
|
|
|
|
|
|
|
|
|
|
|
80,274
|
|
|
1
|
|
|
(1
|
)
|
|
|
|
|
|
|
|
—
|
|
||||||
Cumulative translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(414
|
)
|
|
(414
|
)
|
||||||
Net loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(15,191
|
)
|
|
—
|
|
|
(15,191
|
)
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Balance, December 31, 2017
|
|
—
|
|
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
53,400,281
|
|
|
$
|
554
|
|
|
$
|
106,312
|
|
|
$
|
(60,094
|
)
|
|
$
|
(2,019
|
)
|
|
$
|
44,753
|
|
|
|
Useful Lives
|
|
|
|
Buildings and improvements
|
|
10 - 40 years
|
Machinery and equipment
|
|
5 - 15 years
|
Computer hardware and software
|
|
3 - 5 years
|
Furniture and fixtures
|
|
5 years
|
|
|
2017
|
|
2016
|
|
2015
|
||||||
Basic earnings (loss) per share computation:
|
|
|
|
|
|
|
|
|
|
|||
Net income (loss) attributable to common stockholders —basic
|
|
$
|
(15,191
|
)
|
|
$
|
(11,985
|
)
|
|
$
|
6,668
|
|
Weighted average common shares —basic
|
|
53,323,954
|
|
|
53,078,158
|
|
|
52,872,814
|
|
|||
Basic earnings (loss) per share
|
|
$
|
(0.28
|
)
|
|
$
|
(0.23
|
)
|
|
$
|
0.13
|
|
|
|
|
|
|
|
|
||||||
Dilutive earnings (loss) per share computation:
|
|
|
|
|
|
|
|
|
|
|||
Net income (loss) attributable to common stockholders —basic
|
|
$
|
(15,191
|
)
|
|
$
|
(11,985
|
)
|
|
$
|
6,668
|
|
Interest expense related to convertible 3.75% senior notes
|
|
—
|
|
|
—
|
|
|
5,391
|
|
|||
Amortization of discount related to convertible 3.75% senior notes
|
|
—
|
|
|
$
|
—
|
|
|
$
|
6,680
|
|
|
Change in the fair value of derivative
|
|
—
|
|
|
$
|
—
|
|
|
$
|
(23,144
|
)
|
|
Net loss attributable to common stockholders —diluted
|
|
$
|
(15,191
|
)
|
|
$
|
(11,985
|
)
|
|
$
|
(4,405
|
)
|
Share Computation:
|
|
|
|
|
|
|
|
|
|
|||
Weighted average common shares —basic
|
|
53,323,954
|
|
|
53,078,158
|
|
|
52,872,814
|
|
|||
Effect of convertible 3.75% senior notes
|
|
—
|
|
|
—
|
|
|
12,732,168
|
|
|||
Effect of dilutive stock options and warrants
|
|
—
|
|
|
—
|
|
|
1,507,013
|
|
|||
Weighted average common shares outstanding —diluted
|
|
53,323,954
|
|
|
53,078,158
|
|
|
67,111,995
|
|
|||
Diluted net loss per share
|
|
$
|
(0.28
|
)
|
|
$
|
(0.23
|
)
|
|
$
|
(0.07
|
)
|
|
|
2017
|
|
2016
|
||||
|
|
(in thousands)
|
||||||
Raw materials
|
|
$
|
8,231
|
|
|
$
|
6,834
|
|
Work in progress
|
|
616
|
|
|
—
|
|
||
Finished goods
|
|
8,532
|
|
|
6,284
|
|
||
Reserve for obsolescence
|
|
(1,304
|
)
|
|
(410
|
)
|
||
|
|
$
|
16,075
|
|
|
$
|
12,708
|
|
|
|
2017
|
|
2016
|
||||
|
|
(in thousands)
|
||||||
Land
|
|
$
|
257
|
|
|
$
|
257
|
|
Building and improvements
|
|
8,613
|
|
|
8,515
|
|
||
Machinery and equipment
|
|
9,142
|
|
|
7,515
|
|
||
Computer hardware and software
|
|
3,244
|
|
|
724
|
|
||
Furniture and fixtures
|
|
449
|
|
|
344
|
|
||
Construction in progress
|
|
55,017
|
|
|
15,496
|
|
||
|
|
76,722
|
|
|
32,851
|
|
||
Less accumulated depreciation and amortization
|
|
(8,367
|
)
|
|
(6,636
|
)
|
||
Property, plant and equipment, net
|
|
$
|
68,355
|
|
|
$
|
26,215
|
|
|
December 31, 2017
|
|
December 31, 2016
|
||||
|
(in thousands)
|
|
(in thousands)
|
||||
|
|
|
|
||||
Face amount of the Notes
|
$
|
143,750
|
|
|
$
|
143,750
|
|
Unamortized discount
|
20,517
|
|
|
29,160
|
|
||
Debt issuance costs
|
2,256
|
|
|
3,199
|
|
||
Carrying amount of the Notes
|
$
|
120,977
|
|
|
$
|
111,391
|
|
|
December 31,
2017 |
|
December 31,
2016 |
|
December 31,
2015 |
||||||
|
(in thousands)
|
|
(in thousands)
|
|
(in thousands)
|
||||||
|
|
|
|
|
|
||||||
Interest Expense at 3.75% coupon rate
|
$
|
5,391
|
|
|
$
|
5,391
|
|
|
$
|
5,391
|
|
Debt discount amortization
|
8,643
|
|
|
7,599
|
|
|
6,680
|
|
|||
Amortization of deferred financing costs
|
942
|
|
|
828
|
|
|
728
|
|
|||
Less: capitalized interest and other
|
(3,778
|
)
|
|
(514
|
)
|
|
559
|
|
|||
Total interest expense
|
$
|
11,198
|
|
|
$
|
13,304
|
|
|
$
|
13,358
|
|
|
|
Years ended December 31,
|
||||||||||
|
|
2017
|
|
2016
|
|
2015
|
||||||
Gross product sales
|
|
$
|
215,883
|
|
|
$
|
217,633
|
|
|
$
|
99,721
|
|
|
|
|
|
|
|
|
||||||
Reduction to gross product sales:
|
|
|
|
|
|
|
|
|
||||
Chargebacks and billbacks
|
|
125,159
|
|
|
141,343
|
|
|
50,127
|
|
|||
Sales discounts and other allowances
|
|
32,720
|
|
|
27,419
|
|
|
17,974
|
|
|||
Total reduction to gross product sales
|
|
$
|
157,879
|
|
|
$
|
168,762
|
|
|
$
|
68,101
|
|
|
|
|
|
|
|
|
||||||
Product sales, net
|
|
$
|
58,004
|
|
|
$
|
48,871
|
|
|
$
|
31,620
|
|
|
|
|
|
|
|
|
||||||
Contract manufacturing product sales
|
|
$
|
8,995
|
|
|
$
|
17,033
|
|
|
$
|
11,877
|
|
|
|
|
|
|
|
|
||||||
Total product sales, net
|
|
$
|
66,999
|
|
|
$
|
65,904
|
|
|
$
|
43,497
|
|
|
|
Returns
|
|
Chargebacks & Rebates
|
|
Discounts
|
|
Doubtful Accounts
|
|
TOTAL
|
||||||||||
Balance at December 31, 2014
|
|
$
|
674
|
|
|
$
|
4,552
|
|
|
$
|
345
|
|
|
$
|
16
|
|
|
$
|
5,587
|
|
Provision
|
|
1,724
|
|
|
65,713
|
|
|
2,201
|
|
|
74
|
|
|
69,712
|
|
|||||
Charges processed
|
|
(1,464
|
)
|
|
(57,815
|
)
|
|
(1,754
|
)
|
|
—
|
|
|
(61,033
|
)
|
|||||
Balance at December 31, 2015
|
|
$
|
934
|
|
|
$
|
12,450
|
|
|
$
|
792
|
|
|
$
|
90
|
|
|
$
|
14,266
|
|
Provision
|
|
3,568
|
|
|
160,556
|
|
|
4,667
|
|
|
347
|
|
|
169,138
|
|
|||||
Charges processed
|
|
(2,192
|
)
|
|
(137,125
|
)
|
|
(2,156
|
)
|
|
(20
|
)
|
|
(141,493
|
)
|
|||||
Balance at December 31, 2016
|
|
$
|
2,310
|
|
|
$
|
35,881
|
|
|
$
|
3,303
|
|
|
$
|
417
|
|
|
$
|
41,911
|
|
Provision
|
|
6,034
|
|
|
148,000
|
|
|
4,398
|
|
|
1,768
|
|
|
160,200
|
|
|||||
Charges processed
|
|
(7,023
|
)
|
|
(159,809
|
)
|
|
(6,737
|
)
|
|
—
|
|
|
(173,569
|
)
|
|||||
Balance at December 31, 2017
|
|
$
|
1,321
|
|
|
$
|
24,072
|
|
|
$
|
964
|
|
|
$
|
2,185
|
|
|
$
|
28,542
|
|
|
Goodwill
|
||
December 31, 2015
|
$
|
426
|
|
Foreign currency translation
|
20
|
|
|
December 31, 2016
|
446
|
|
|
Foreign currency translation
|
25
|
|
|
December 31, 2017
|
$
|
471
|
|
|
|
December 31, 2017
|
|
|
||||||||||
|
|
Gross Carrying
Amount |
|
Accumulated
Amortization |
|
Net Carrying
Amount |
|
Weighted Average
Remaining Amortization Period |
||||||
Trademarks and Technology
|
|
$
|
40,380
|
|
|
$
|
(5,684
|
)
|
|
$
|
34,696
|
|
|
12.8
|
In-process research and development
(“IPR&D”) |
|
18,311
|
|
|
—
|
|
|
18,311
|
|
|
N/A - Indefinite lived
|
|||
Customer relationships
|
|
3,783
|
|
|
(773
|
)
|
|
3,010
|
|
|
7.9
|
|||
Total
|
|
$
|
62,474
|
|
|
$
|
(6,457
|
)
|
|
$
|
56,017
|
|
|
|
|
|
December 31, 2016
|
|
|
||||||||||
|
|
Gross Carrying
Amount |
|
Accumulated
Amortization |
|
Net Carrying
Amount |
|
Weighted Average
Remaining Amortization Period |
||||||
Trademarks and Technology
|
|
$
|
35,403
|
|
|
$
|
(3,123
|
)
|
|
$
|
32,280
|
|
|
13.8
|
In-process research and development
(“IPR&D”) |
|
17,024
|
|
|
—
|
|
|
17,024
|
|
|
N/A - Indefinite lived
|
|||
Customer relationships
|
|
3,565
|
|
|
(404
|
)
|
|
3,161
|
|
|
8.9
|
|||
Total
|
|
$
|
55,992
|
|
|
$
|
(3,527
|
)
|
|
$
|
52,465
|
|
|
|
|
|
Trademarks and
Technology |
|
IPR&D
|
|
Customer
Relationships |
||||||
December 31, 2015
|
|
$
|
36,552
|
|
|
$
|
14,351
|
|
|
$
|
3,417
|
|
Acquisition
|
|
661
|
|
|
2,811
|
|
|
—
|
|
|||
Amortization
|
|
(2,472
|
)
|
|
—
|
|
|
(361
|
)
|
|||
Foreign currency translation
|
|
(2,461
|
)
|
|
(138
|
)
|
|
105
|
|
|||
December 31, 2016
|
|
32,280
|
|
|
17,024
|
|
|
3,161
|
|
|||
Acquisition
|
|
|
|
|
|
|
|
|
|
|||
Amortization
|
|
(2,561
|
)
|
|
—
|
|
|
(369
|
)
|
|||
IPR&D placed in service
|
|
834
|
|
|
(834
|
)
|
|
—
|
|
|||
Impairment
|
|
—
|
|
|
(113
|
)
|
|
—
|
|
|||
Foreign currency translation
|
|
4,143
|
|
|
2,234
|
|
|
218
|
|
|||
December 31, 2017
|
|
$
|
34,696
|
|
|
$
|
18,311
|
|
|
$
|
3,010
|
|
Year ending December 31,
|
|
Amortization Expense *
|
|
2018
|
|
2,930
|
|
2019
|
|
2,930
|
|
2020
|
|
2,930
|
|
2021
|
|
2,930
|
|
2022
|
|
2,930
|
|
Thereafter
|
|
23,058
|
|
Intangibles Category
|
|
Amortizable Life
|
Trademarks and Technology
|
|
15 years
|
Customer Relationships
|
|
10 years
|
Assumptions
|
|
2017
|
|
|
2016
|
|
|
2015
|
|
Expected dividends
|
|
0
|
%
|
|
0
|
%
|
|
0
|
%
|
Risk free rate
|
|
1.56
|
%
|
|
1.14
|
%
|
|
1.11
|
%
|
Expected volatility
|
|
58.0% - 69.7%
|
|
|
68.0% - 71.3%
|
|
|
52.7% - 68.3%
|
|
Expected term (in years)
|
|
3.2 – 3.3 years
|
|
|
3.1 – 3.3 years
|
|
|
3.2 – 3.3 years
|
|
|
|
Shares
|
|
Exercise
Price Per Share |
|
Weighted
Average Exercise Price |
||||
January 1, 2015 shares issuable under options
|
|
2,436,834
|
|
|
0.76 - 10.55
|
|
|
$
|
1.79
|
|
Granted
|
|
1,357,000
|
|
|
5.55 - 10.67
|
|
|
9.20
|
|
|
Exercised
|
|
(75,766
|
)
|
|
0.76 - 3.62
|
|
|
1.10
|
|
|
Expired
|
|
—
|
|
|
—
|
|
|
—
|
|
|
Forfeited
|
|
(125,334
|
)
|
|
1.40 – 10.67
|
|
|
8.99
|
|
|
December 31, 2015 shares issuable under options
|
|
3,592,734
|
|
|
0.79 - 10.67
|
|
|
4.36
|
|
|
Granted
|
|
739,135
|
|
|
4.72 - 8.81
|
|
|
7.26
|
|
|
Exercised
|
|
(61,834
|
)
|
|
1.10 - 6.51
|
|
|
1.54
|
|
|
Expired
|
|
—
|
|
|
—
|
|
|
—
|
|
|
Forfeited
|
|
(164,666
|
)
|
|
4.55 - 10.67
|
|
|
8.37
|
|
|
December 31, 2016 shares issuable under options
|
|
4,105,369
|
|
|
0.79 - 10.67
|
|
|
4.76
|
|
|
Granted
|
|
577,845
|
|
|
3.38 - 9.28
|
|
|
7.15
|
|
|
Exercised
|
|
(171,566
|
)
|
|
0.79 - 5.85
|
|
|
1.92
|
|
|
Expired
|
|
—
|
|
|
—
|
|
|
—
|
|
|
Forfeited
|
|
(211,838
|
)
|
|
4.80 - 10.67
|
|
|
7.70
|
|
|
December 31, 2017 shares issuable under options
|
|
4,299,810
|
|
|
$0.79 - $10.67
|
|
|
$
|
4.76
|
|
|
|
Options Outstanding
|
|
Options Exercisable
|
||||||||||||
Range of
Exercise Price |
|
Number of
Options |
|
Weighted
Average Remaining Life (Years ) |
|
Weighted
Average Exercise Price |
|
Number of
Options |
|
Weighted
Average Exercise Price |
||||||
$0.79 - $1.00
|
|
25,000
|
|
|
2.01
|
|
$
|
0.79
|
|
|
25,000
|
|
|
$
|
0.79
|
|
1.01 - 1.50
|
|
1,721,000
|
|
|
4.14
|
|
1.06
|
|
|
1,721,000
|
|
|
1.06
|
|
||
1.51 - 10.67
|
|
2,553,810
|
|
|
7.76
|
|
7.85
|
|
|
1,369,466
|
|
|
7.92
|
|
||
|
|
|
|
|
|
|
|
|
|
|
||||||
$0.79 - $10.67
|
|
4,299,810
|
|
|
6.28
|
|
$
|
5.09
|
|
|
3,115,466
|
|
|
$
|
4.07
|
|
|
|
Options Outstanding
|
|
Options Exercisable
|
||||||||||||
Range of
Exercise Price |
|
Number of
Options |
|
Weighted
Average Remaining Life (Years ) |
|
Weighted
Average Exercise Price |
|
Number of
Options |
|
Weighted
Average Exercise Price |
||||||
$0.79 - $1.00
|
|
50,000
|
|
|
3.01
|
|
$
|
0.79
|
|
|
50,000
|
|
|
$
|
0.79
|
|
1.01 - 1.50
|
|
1,808,400
|
|
|
5.11
|
|
1.07
|
|
|
1,808,400
|
|
|
1.07
|
|
||
1.51 - 10.67
|
|
2,246,969
|
|
|
8.35
|
|
7.82
|
|
|
805,803
|
|
|
7.15
|
|
||
|
|
|
|
|
|
|
|
|
|
|
||||||
$0.79 - $10.67
|
|
4,105,369
|
|
|
6.86
|
|
$
|
4.76
|
|
|
2,664,203
|
|
|
$
|
2.90
|
|
|
|
Options Outstanding
|
|
Options Exercisable
|
||||||||||||
Range of
Exercise Price |
|
Number of
Options |
|
Weighted
Average Remaining Life (Years ) |
|
Weighted
Average Exercise Price |
|
Number of
Options |
|
Weighted
Average Exercise Price |
||||||
$0.76 - $1.00
|
|
50,000
|
|
|
4.01
|
|
$
|
0.79
|
|
|
50,000
|
|
|
$
|
0.79
|
|
1.01 - 1.50
|
|
1,862,400
|
|
|
6.14
|
|
1.07
|
|
|
1,851,400
|
|
|
1.07
|
|
||
1.51 - 10.55
|
|
1,680,334
|
|
|
8.96
|
|
8.10
|
|
|
289,997
|
|
|
4.02
|
|
||
|
|
|
|
|
|
|
|
|
|
|
||||||
$0.79 - $10.67
|
|
3,592,734
|
|
|
7.43
|
|
$
|
4.36
|
|
|
2,191,397
|
|
|
$
|
1.45
|
|
|
|
Options
|
|
Weighted
Average Grant Date Fair Value |
|||
Non-vested options at January 1, 2017
|
|
1,441,166
|
|
|
$
|
3.58
|
|
Granted
|
|
577,845
|
|
|
3.37
|
|
|
Vested
|
|
(654,156
|
)
|
|
3.62
|
|
|
Forfeited
|
|
(180,511
|
)
|
|
3.46
|
|
|
Non-vested options at December 31, 2017
|
|
1,184,344
|
|
|
$
|
3.48
|
|
|
|
Number of
Restricted Stock |
|
Weighted Average
Issuance Price |
|||
Non-vested balance at January 1, 2015
|
|
108,334
|
|
|
$
|
2.86
|
|
|
|
|
|
|
|||
Changes during the period:
|
|
|
|
|
|
|
|
Shares granted
|
|
32,500
|
|
|
10.67
|
|
|
Shares vested
|
|
(140,834
|
)
|
|
4.66
|
|
|
Shares forfeited
|
|
—
|
|
|
|
|
|
Non-vested balance at January 1, 2016
|
|
—
|
|
|
$
|
—
|
|
|
|
Number of
RSUs |
|
Weighted Average
Issuance Price |
|||
Non-vested balance at January 1, 2016
|
|
182,750
|
|
|
$
|
10.23
|
|
|
|
|
|
|
|||
Changes during the period:
|
|
|
|
|
|
|
|
Shares granted
|
|
58,068
|
|
|
7.50
|
|
|
Shares vested
|
|
(60,918
|
)
|
|
10.13
|
|
|
Shares forfeited
|
|
—
|
|
|
—
|
|
|
Non-vested balance at December 31, 2016
|
|
179,900
|
|
|
$
|
9.35
|
|
|
|
|
|
|
|||
Changes during the period:
|
|
|
|
|
|||
Shares granted
|
|
93,468
|
|
|
7.26
|
|
|
Shares vested
|
|
(80,274
|
)
|
|
9.57
|
|
|
Shares forfeited
|
|
(4,465
|
)
|
|
7.09
|
|
|
Non-vested balance at December 31, 2017
|
|
188,629
|
|
|
$
|
9.35
|
|
|
|
2017
|
|
2016
|
||||
|
|
(in thousands)
|
||||||
Wholesaler fees
|
|
$
|
7,044
|
|
|
$
|
3,505
|
|
Capital expenditures
|
|
1,947
|
|
|
2,475
|
|
||
Payroll
|
|
1,580
|
|
|
1,706
|
|
||
Royalties
|
|
856
|
|
|
843
|
|
||
Studies
|
|
596
|
|
|
153
|
|
||
Professional fees
|
|
546
|
|
|
715
|
|
||
Interest expense
|
|
240
|
|
|
240
|
|
||
Income Tax
|
|
58
|
|
|
192
|
|
||
Other
|
|
635
|
|
|
520
|
|
||
|
|
$
|
13,502
|
|
|
$
|
10,349
|
|
|
|
2017
|
|
2016
|
|
2015
|
||||||
|
|
(in thousands)
|
||||||||||
U.S. operations
|
|
$
|
(21,938
|
)
|
|
$
|
(9,514
|
)
|
|
$
|
6,911
|
|
Foreign operations
|
|
6,662
|
|
|
(2,184
|
)
|
|
(208
|
)
|
|||
|
|
|
|
|
|
|
||||||
Global Total
|
|
$
|
(15,276
|
)
|
|
$
|
(11,698
|
)
|
|
$
|
6,703
|
|
|
|
2017
|
|
2016
|
|
2015
|
||||||
|
|
|
|
|
|
|
||||||
Current tax expense (benefit):
|
|
|
|
|
|
|
|
|
|
|||
Federal
|
|
$
|
(86
|
)
|
|
$
|
26
|
|
|
$
|
—
|
|
State and local
|
|
20
|
|
|
35
|
|
|
19
|
|
|||
Foreign
|
|
42
|
|
|
272
|
|
|
28
|
|
|||
Total current tax expense
|
|
(24
|
)
|
|
333
|
|
|
47
|
|
|||
Deferred tax expense:
|
|
|
|
|
|
|
|
|
|
|||
Federal
|
|
—
|
|
|
—
|
|
|
—
|
|
|||
State and local
|
|
—
|
|
|
—
|
|
|
—
|
|
|||
Foreign
|
|
(61
|
)
|
|
(46
|
)
|
|
(12
|
)
|
|||
Total deferred tax expense
|
|
(61
|
)
|
|
(46
|
)
|
|
(12
|
)
|
|||
|
|
|
|
|
|
|
||||||
Total income tax (benefit)/expense
|
|
$
|
(85
|
)
|
|
$
|
287
|
|
|
$
|
35
|
|
|
|
2017
|
|
2016
|
|
2015
|
||||||
|
|
|
|
|
|
|
||||||
Expected Statutory expense (benefit)
|
|
$
|
(5,195
|
)
|
|
$
|
(3,977
|
)
|
|
$
|
2,244
|
|
U.S. TCJA recovery of alternative minimum tax credits
|
|
(73
|
)
|
|
—
|
|
|
—
|
|
|||
Change in the fair values of derivative and amortization of debt discount
|
|
2,939
|
|
|
2,584
|
|
|
(5,597
|
)
|
|||
Other non-deductible expenses
|
|
24
|
|
|
63
|
|
|
7
|
|
|||
Change in valuation allowance including U.S. TCJA rate reduction
|
|
(2,012
|
)
|
|
590
|
|
|
3,254
|
|
|||
Reduction in deferred tax assets related to U.S. TCJA rate reduction
|
|
7,504
|
|
|
—
|
|
|
—
|
|
|||
Shortfalls related to stock compensation expense
|
|
129
|
|
|
154
|
|
|
—
|
|
|||
Tax rate differential - foreign vs. U.S.
|
|
(2,276
|
)
|
|
822
|
|
|
114
|
|
|||
State income taxes, net of federal benefit
|
|
13
|
|
|
23
|
|
|
13
|
|
|||
Shortfalls related to stock compensation expense
|
|
129
|
|
|
154
|
|
|
—
|
|
|||
Prior year true-up
|
|
(13
|
)
|
|
—
|
|
|
—
|
|
|||
Exchange gain
|
|
(13
|
)
|
|
28
|
|
|
—
|
|
|||
|
|
$
|
(85
|
)
|
|
$
|
287
|
|
|
$
|
35
|
|
|
|
2017
|
|
2016
|
||||
|
|
(in thousands)
|
||||||
Deferred Tax Assets:
|
|
|
|
|
|
|
||
Allowance for doubtful accounts
|
|
$
|
506
|
|
|
$
|
118
|
|
Inventory reserve
|
|
619
|
|
|
467
|
|
||
Accrued expenses
|
|
664
|
|
|
831
|
|
||
Property, plant and equipment
|
|
214
|
|
|
317
|
|
||
Tax operating loss carryforwards
|
|
9,327
|
|
|
10,962
|
|
||
Tax credit carryforwards
|
|
168
|
|
|
254
|
|
||
Stock compensation
|
|
1,817
|
|
|
2,301
|
|
||
Total deferred tax assets
|
|
13,315
|
|
|
15,250
|
|
||
Less valuation allowance
|
|
(13,309
|
)
|
|
(15,250
|
)
|
||
Net deferred tax assets
|
|
6
|
|
|
—
|
|
||
Deferred Tax Liabilities:
|
|
|
|
|
||||
Intangible assets
|
|
(165
|
)
|
|
(205
|
)
|
||
Total deferred tax liabilities
|
|
(165
|
)
|
|
(205
|
)
|
||
Net deferred tax liability
|
|
$
|
(159
|
)
|
|
$
|
(205
|
)
|
Valuation allowance at beginning of year
|
|
$
|
15,250
|
|
Change in accounting for stock compensation windfalls
|
|
1,112
|
|
|
Current year operating loss
|
|
3,048
|
|
|
Change in tax rate to 21%
|
|
(7,504
|
)
|
|
Other
|
|
1,403
|
|
|
Valuation allowance at end of year
|
|
$
|
13,309
|
|
|
|
2017
|
|
2016
|
||||
|
|
(in thousands)
|
||||||
Federal:
|
|
|
|
|
|
|||
Net operating losses (expiring through 2037)
|
|
$
|
41,688
|
|
|
$
|
31,336
|
|
Research tax credits (expiring through 2025)
|
|
168
|
|
|
168
|
|
||
Alternative minimum tax credits (available without expiration)
|
|
—
|
|
|
86
|
|
||
State:
|
|
|
|
|
|
|||
Net Operating Losses:
|
|
|
|
|
||||
Tennessee (expiring in 2032)
|
|
659
|
|
|
529
|
|
||
New Jersey (expiring in 2037)
|
|
4,320
|
|
|
1,764
|
|
||
Illinois (expiring in 2037)
|
|
389
|
|
|
222
|
|
||
Alabama (expiring in 2032)
|
|
24
|
|
|
—
|
|
||
Foreign
|
|
|
|
|
|
|||
Net operating losses (no expiration)
|
|
$
|
255
|
|
|
$
|
232
|
|
Year
|
|
Net Operating Loss (in thousands)
|
||
2020 - 2023
|
|
$
|
8,228
|
|
2024 - 2029
|
|
9,063
|
|
|
2030 - 2031
|
|
6,205
|
|
|
2032 - 2036
|
|
10,016
|
|
|
2037
|
|
8,176
|
|
|
Total
|
|
$
|
41,688
|
|
|
Commitments
|
||
|
|
||
2018
|
$
|
491
|
|
2019
|
436
|
|
|
2020
|
441
|
|
|
2021
|
403
|
|
|
2022
|
327
|
|
|
2023
|
332
|
|
|
Thereafter
|
83
|
|
|
|
$
|
2,513
|
|
|
|
First
Quarter |
|
Second
Quarter |
|
Third
Quarter |
|
Fourth
Quarter |
|
Total
|
||||||||||
|
|
(in thousands, except per share data)
|
||||||||||||||||||
Year Ended December 31, 2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Total revenues, net
|
|
$
|
19,891
|
|
|
$
|
18,408
|
|
|
$
|
12,851
|
|
|
$
|
16,101
|
|
|
$
|
67,251
|
|
Gross profit
|
|
10,934
|
|
|
8,037
|
|
|
2,538
|
|
|
5,863
|
|
|
27,372
|
|
|||||
Operating income (loss)
|
|
2,967
|
|
|
(1,782
|
)
|
|
(8,039
|
)
|
|
(4,943
|
)
|
|
(11,797
|
)
|
|||||
Net income (loss)
|
|
831
|
|
|
(919
|
)
|
|
(8,982
|
)
|
|
(6,121
|
)
|
|
(15,191
|
)
|
|||||
Net income (loss) attributable to common stockholders
|
|
831
|
|
|
(919
|
)
|
|
(8,982
|
)
|
|
(6,121
|
)
|
|
(15,191
|
)
|
|||||
Basic income (loss) per share
|
|
$
|
0.02
|
|
|
$
|
(0.02
|
)
|
|
$
|
(0.17
|
)
|
|
$
|
(0.11
|
)
|
|
$
|
(0.28
|
)
|
Diluted income (loss) per share
|
|
$
|
0.02
|
|
|
$
|
(0.02
|
)
|
|
$
|
(0.17
|
)
|
|
$
|
(0.11
|
)
|
|
$
|
(0.28
|
)
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Year Ended December 31, 2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Total revenues, net
|
|
$
|
15,657
|
|
|
$
|
17,138
|
|
|
$
|
16,151
|
|
|
$
|
17,935
|
|
|
$
|
66,881
|
|
Gross profit
|
|
7,955
|
|
|
9,556
|
|
|
8,014
|
|
|
9,162
|
|
|
34,687
|
|
|||||
Operating income
|
|
837
|
|
|
1,076
|
|
|
303
|
|
|
326
|
|
|
2,542
|
|
|||||
Net loss
|
|
(950
|
)
|
|
(2,901
|
)
|
|
(2,703
|
)
|
|
(5,431
|
)
|
|
(11,985
|
)
|
|||||
Net loss attributable to common stockholders
|
|
(950
|
)
|
|
(2,901
|
)
|
|
(2,703
|
)
|
|
(5,431
|
)
|
|
(11,985
|
)
|
|||||
Basic loss per share
|
|
$
|
(0.02
|
)
|
|
$
|
(0.05
|
)
|
|
$
|
(0.05
|
)
|
|
$
|
(0.11
|
)
|
|
$
|
(0.23
|
)
|
Diluted loss per share
|
|
$
|
(0.02
|
)
|
|
$
|
(0.05
|
)
|
|
$
|
(0.05
|
)
|
|
$
|
(0.11
|
)
|
|
$
|
(0.23
|
)
|
|
|
|
|
Additions
|
|
|
|
|
|||||||||
|
|
Balance at
Beginning of Year |
|
Charged to
Costs and Expenses |
|
Charged
other Accounts |
|
Deductions
|
|
Balance at
End of Year |
|||||||
Year Ended December 31, 2015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Change in Tax Valuation Allowance
|
|
$
|
10,970
|
|
|
—
|
|
|
3,339
|
|
|
—
|
|
|
$
|
14,309
|
|
Allowance for Doubtful Accounts
|
|
$
|
16
|
|
|
74
|
|
|
—
|
|
|
—
|
|
|
$
|
90
|
|
Reserve for Inventory Obsolescence
|
|
$
|
212
|
|
|
51
|
|
|
(8
|
)
|
|
134
|
|
|
$
|
121
|
|
Year Ended December 31, 2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Change in Tax Valuation Allowance
|
|
$
|
14,309
|
|
|
—
|
|
|
941
|
|
|
—
|
|
|
$
|
15,250
|
|
Allowance for Doubtful Accounts
|
|
$
|
90
|
|
|
347
|
|
|
—
|
|
|
20
|
|
|
$
|
417
|
|
Reserve for Inventory Obsolescence
|
|
$
|
121
|
|
|
872
|
|
|
—
|
|
|
583
|
|
|
$
|
410
|
|
Year Ended December 31, 2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Change in Tax Valuation Allowance
|
|
$
|
15,250
|
|
|
(61
|
)
|
|
(1,880
|
)
|
|
—
|
|
|
$
|
13,309
|
|
Allowance for Doubtful Accounts
|
|
$
|
417
|
|
|
1,768
|
|
|
|
|
—
|
|
|
$
|
2,185
|
|
|
Reserve for Inventory Obsolescence
|
|
$
|
410
|
|
|
2,000
|
|
|
9
|
|
|
1,115
|
|
|
$
|
1,304
|
|
Date: March 19, 2018
|
|
|
|
/s/ Jason Grenfell-Gardner
|
|
Principal Executive Officer
|
|
Date: March 19, 2018
|
|
|
|
/s/ Damian Finio
|
|
Principal Financial Officer
|
|
Dated:
March 19, 2018
|
/s/ Jason Grenfell-Gardner
|
|
Principal Executive Officer
|
|
|
Dated:
March 19, 2018
|
/s/ Damian Finio
|
|
Principal Financial Officer
|