Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2014 | Oct. 17, 2014 | |
Document and Entity Information [Abstract] | ' | ' |
Entity Registrant Name | 'VASCULAR SOLUTIONS INC | ' |
Entity Central Index Key | '0001030206 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Well-known Seasoned Issuer | 'No | ' |
Entity Voluntary Filers | 'No | ' |
Entity Current Reporting Status | 'Yes | ' |
Entity Filer Category | 'Accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 17,176,422 |
Document Fiscal Year Focus | '2014 | ' |
Document Fiscal Period Focus | 'Q3 | ' |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 30-Sep-14 | ' |
Consolidated_Balance_Sheets_un
Consolidated Balance Sheets (unaudited) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Current assets: | ' | ' |
Cash and cash equivalents | $41,649,000 | $30,785,000 |
Accounts receivable, net of reserves of $285,000 and $200,000 in 2014 and 2013, respectively | 16,091,000 | 14,481,000 |
Inventories | 15,732,000 | 14,002,000 |
Prepaid expenses and other | 4,478,000 | 2,472,000 |
Current portion of deferred tax assets | 6,000,000 | 6,000,000 |
Total current assets | 83,950,000 | 67,740,000 |
Property, plant and equipment, net | 17,616,000 | 16,187,000 |
Goodwill | 10,346,000 | 10,532,000 |
Intangible assets, net | 10,614,000 | 11,943,000 |
Deferred tax assets, net of current portion | 594,000 | 1,739,000 |
Total assets | 123,120,000 | 108,141,000 |
Current liabilities: | ' | ' |
Accounts payable | 4,847,000 | 3,762,000 |
Accrued compensation | 5,074,000 | 4,365,000 |
Accrued expenses | 3,683,000 | 2,467,000 |
Accrued royalties | 229,000 | 235,000 |
Current portion of deferred revenue | 425,000 | 556,000 |
Total current liabilities | 14,258,000 | 11,385,000 |
Long-term deferred revenue, net of current portion | 253,000 | 406,000 |
Long-term deferred tax liabilities | 723,000 | 0 |
Total long-term liabilities | 976,000 | 406,000 |
Shareholders' equity: | ' | ' |
Common stock, $0.01 par value: Authorized shares - 40,000,000 Issued and outstanding shares - 17,176,172 - 2014; 16,964,953 - 2013 | 172,000 | 170,000 |
Additional paid-in capital | 95,853,000 | 92,346,000 |
Accumulated other comprehensive earnings | -548,000 | -1,000 |
Retained earnings | 12,409,000 | 3,835,000 |
Total shareholders' equity | 107,886,000 | 96,350,000 |
Total liabilities and shareholders' equity | $123,120,000 | $108,141,000 |
Consolidated_Balance_Sheets_un1
Consolidated Balance Sheets (unaudited) (Parenthetical) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Current assets: | ' | ' |
Reserves for accounts receivable | $285,000 | $200,000 |
Shareholders' equity: | ' | ' |
Common stock, par value (in dollars per share) | $0.01 | $0.01 |
Common stock, authorized shares (in shares) | 40,000,000 | 40,000,000 |
Common stock, shares issued (in shares) | 17,176,172 | 16,964,953 |
Common stock, shares outstanding (in shares) | 17,176,172 | 16,964,953 |
Consolidated_Statements_of_Ear
Consolidated Statements of Earnings (unaudited) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Net revenue: | ' | ' | ' | ' |
Product revenue | $31,766,000 | $27,926,000 | $92,216,000 | $81,197,000 |
License, royalty and collaboration revenue | 163,000 | 83,000 | 297,000 | 230,000 |
Total revenue | 31,929,000 | 28,009,000 | 92,513,000 | 81,427,000 |
Product costs and operating expenses: | ' | ' | ' | ' |
Cost of goods sold | 10,291,000 | 9,197,000 | 30,158,000 | 26,432,000 |
Collaboration expenses | 93,000 | 32,000 | 125,000 | 41,000 |
Research and development | 3,322,000 | 3,140,000 | 9,839,000 | 10,027,000 |
Clinical and regulatory | 1,196,000 | 997,000 | 3,771,000 | 3,259,000 |
Sales and marketing | 7,327,000 | 6,706,000 | 22,406,000 | 20,462,000 |
General and administrative | 3,692,000 | 2,362,000 | 9,282,000 | 6,871,000 |
Litigation | 0 | 812,000 | 0 | 812,000 |
Medical device excise taxes | 385,000 | 339,000 | 1,083,000 | 995,000 |
Amortization of purchased technology and intangibles | 410,000 | 404,000 | 1,234,000 | 1,162,000 |
Total product costs and operating expenses | 26,716,000 | 23,989,000 | 77,898,000 | 70,061,000 |
Operating earnings | 5,213,000 | 4,020,000 | 14,615,000 | 11,366,000 |
Other earnings (expenses): | ' | ' | ' | ' |
Interest expense | 0 | -3,000 | 0 | -9,000 |
Foreign exchange gain (loss) | -9,000 | 7,000 | -8,000 | -2,000 |
Earnings before income taxes | 5,204,000 | 4,024,000 | 14,607,000 | 11,355,000 |
Income tax expense | -2,634,000 | -1,352,000 | -6,033,000 | -3,750,000 |
Net earnings | $2,570,000 | $2,672,000 | $8,574,000 | $7,605,000 |
Net earnings per share - basic (in dollars per share) | $0.15 | $0.16 | $0.51 | $0.47 |
Net earnings per share - diluted (in dollars per share) | $0.15 | $0.16 | $0.49 | $0.45 |
Consolidated_Statements_of_Com
Consolidated Statements of Comprehensive Earnings (unaudited) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Consolidated Statements of Comprehensive Earnings (unaudited) [Abstract] | ' | ' | ' | ' |
Net earnings | $2,570,000 | $2,672,000 | $8,574,000 | $7,605,000 |
Other comprehensive earnings (losses), net of $0 tax: Foreign currency translation adjustments | -346,000 | 192,000 | -547,000 | 61,000 |
Comprehensive earnings | $2,224,000 | $2,864,000 | $8,027,000 | $7,666,000 |
Consolidated_Statements_of_Com1
Consolidated Statements of Comprehensive Earnings (unaudited) (Parenthetical) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Consolidated Statements of Comprehensive Earnings (unaudited) [Abstract] | ' | ' | ' | ' |
Foreign currency translation adjustments, tax | $0 | $0 | $0 | $0 |
Consolidated_Statements_of_Cas
Consolidated Statements of Cash Flows (unaudited) (USD $) | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 2013 | |
Operating activities | ' | ' |
Net earnings | $8,574,000 | $7,605,000 |
Adjustments to reconcile net earnings to net cash provided by operating activities: | ' | ' |
Depreciation | 2,381,000 | 2,109,000 |
Amortization | 1,234,000 | 1,162,000 |
Stock-based compensation | 3,030,000 | 2,567,000 |
Deferred taxes, net | 1,868,000 | 2,275,000 |
Excess tax benefit from stock-based compensation | 0 | -1,331,000 |
Change in fair value of contingent consideration | 0 | -79,000 |
Gain on disposal of equipment | -24,000 | -22,000 |
Change in accounts receivable allowance | 85,000 | 15,000 |
Changes in operating assets and liabilities: | ' | ' |
Accounts receivable | -1,708,000 | -691,000 |
Inventories | -1,738,000 | -685,000 |
Prepaid expenses and other | -2,038,000 | -176,000 |
Accounts payable | 1,099,000 | 127,000 |
Accrued expenses and compensation | 1,776,000 | 659,000 |
Amortization of deferred license fees and other deferred revenue | -285,000 | 101,000 |
Net cash provided by operating activities | 14,254,000 | 13,636,000 |
Investing activities | ' | ' |
Purchase of property and equipment | -3,829,000 | -3,486,000 |
Cash paid for acquisition of license | 0 | -500,000 |
Proceeds from the sale of equipment | 28,000 | 22,000 |
Net cash used in investing activities | -3,801,000 | -3,964,000 |
Financing activities | ' | ' |
Repurchase of common shares | -2,312,000 | -1,211,000 |
Excess tax benefit from stock-based compensation | 1,182,000 | 1,331,000 |
Proceeds from the exercise of stock options and sale of stock, net of expenses | 1,609,000 | 2,759,000 |
Net cash provided by financing activities | 479,000 | 2,879,000 |
Increase in cash and cash equivalents | 10,932,000 | 12,551,000 |
Effect of exchange rate changes on cash and cash equivalents | -68,000 | -3,000 |
Cash and cash equivalents at beginning of period | 30,785,000 | 11,554,000 |
Cash and cash equivalents at end of period | 41,649,000 | 24,102,000 |
Supplemental disclosure of cash flow | ' | ' |
Cash paid for interest | 3,000 | 9,000 |
Cash paid for taxes | $3,844,000 | $1,499,000 |
Basis_of_Presentation
Basis of Presentation | 9 Months Ended | |
Sep. 30, 2014 | ||
Basis of Presentation [Abstract] | ' | |
Basis of Presentation | ' | |
-1 | Basis of Presentation | |
The accompanying unaudited consolidated financial statements of Vascular Solutions, Inc. (the Company) have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all normal, recurring adjustments considered necessary for a fair presentation have been included. The consolidated financial statements should be read in conjunction with the audited consolidated financial statements contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013 filed with the Securities and Exchange Commission. Interim results of operations are not necessarily indicative of the results to be expected for the full year or any other interim periods. |
Net_Earnings_per_Share
Net Earnings per Share | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Net Earnings per Share [Abstract] | ' | ||||||||||||||||
Net Earnings per Share | ' | ||||||||||||||||
-2 | Net Earnings per Share | ||||||||||||||||
In accordance with Accounting Standards Codification (ASC) 260, Earnings Per Share, basic net earnings per share for the three and nine months ended September 30, 2014 and 2013 is computed by dividing net earnings by the weighted average common shares outstanding during the periods presented. Diluted net earnings per weighted average common share is computed by dividing net earnings by the weighted average common shares outstanding during the period, increased to include dilutive potential common shares issuable upon the exercise of stock options and restricted stock awards that were outstanding during the period. | |||||||||||||||||
Weighted average common shares outstanding for the three and nine months ended September 30, 2014 and 2013 were as follows: | |||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
(unaudited) | (unaudited) | ||||||||||||||||
Weighted average shares outstanding – basic | 16,871,000 | 16,451,000 | 16,827,000 | 16,299,000 | |||||||||||||
Weighted average shares outstanding – diluted | 17,691,000 | 17,067,000 | 17,642,000 | 16,894,000 |
Revenue_Recognition
Revenue Recognition | 9 Months Ended | |
Sep. 30, 2014 | ||
Revenue Recognition [Abstract] | ' | |
Revenue Recognition | ' | |
-3 | Revenue Recognition | |
In the United States, the Company sells its products and services directly to hospitals and clinics. Revenue is recognized in accordance with generally accepted accounting principles as outlined in ASC 605-10-S99, Revenue Recognition, which requires that four basic criteria be met before revenue can be recognized: (i) persuasive evidence of an arrangement exists; (ii) the price is fixed or determinable; (iii) collectability is reasonably assured; and (iv) product delivery has occurred or services have been rendered. The Company recognizes revenue as products are shipped and title passes to customers based on FOB shipping point terms. The Company negotiates credit terms on a customer-by-customer basis and products are shipped at an agreed-upon price. All product returns must be pre-approved and, if approved, customers are subject to a 20% restocking charge. | ||
In all international markets, the Company sells its products to international distributors which subsequently resell the products to hospitals and clinics. The Company has agreements with each of its distributors which provide that title and risk of loss pass to the distributor upon shipment of the products to the distributor. The Company warrants that its products are free from manufacturing defects at the time of shipment to the distributor. Revenue is recognized upon shipment of products to distributors following the receipt and acceptance of a distributor’s purchase order. Allowances are provided for estimated returns and costs at the time of shipment. Sales and use taxes are reported on a net basis, excluding them from revenue. | ||
The Company’s revenues from license agreements and research collaborations are recognized when earned. In accordance with ASC 605, for revenues which contain multiple deliverables, the Company separates the deliverables into separate accounting units if they meet the following criteria: (i) the delivered items have a stand-alone value to the customer; (ii) the fair value of any undelivered items can be reliably determined; and (iii) if the arrangement includes a general right of return, delivery of the undelivered items is probable and substantially controlled by the seller. Deliverables that do not meet these criteria are combined with one or more other deliverables into one accounting unit. Revenue from each accounting unit is recognized based on the applicable accounting literature, primarily ASC 605. | ||
The Company currently has a license agreement with King Pharmaceuticals, Inc. (King), now a subsidiary of Pfizer, Inc., under which the Company licensed the exclusive rights of Thrombi-Pad®, Thrombi-Gel® and Thrombi-PasteTM products to King in exchange for a license fee. The Company is amortizing the license fees on a straight-line basis over the projected 10 year economic life of the products. The Company determines the economic life of the products under its license agreements by evaluating similar products the Company has launched or other similar products in the medical industry. In addition, the Company had a five-year license agreement with Nicolai, GmbH in which the Company was amortizing the license fee on a straight-line basis over the five-year life of the agreement. This agreement was fully amortized during 2013. | ||
Starting in January 2012, the Company began to generate revenue from selling a reprocessing service for ClosureFAST® radiofrequency catheters. In accordance with ASC 605-45, the Company recognizes this revenue gross, with the amount paid to the supplier of the reprocessing service reflected as cost of goods sold. | ||
In addition, the Company has reviewed the provisions of ASC 808, Collaborative Arrangements, and the adoption of this ASC has had no impact on the amounts recorded under these agreements. In accordance with ASC 605-45-45, the Company includes shipping and handling revenues in net revenue, and shipping and handling costs in cost of goods sold. | ||
In May 2014, the Financial Accounting Standards Board (FASB) issued guidance creating Accounting Standards Codification (“ASC”) Section 606, “Revenue from Contracts with Customers.” The new section will replace Section 605, “Revenue Recognition” and creates modifications to various other revenue accounting standards for specialized transactions and industries. The new section is intended to conform United States revenue accounting principles with concurrently issued International Financial Reporting Standards. Prior to the guidance, revenue recognition differed between United States practice and those of much of the rest of the world. The guidance also is intended to enhance disclosures related to disaggregated revenue information. The updated guidance is effective for annual reporting periods beginning on or after December 15, 2016, and interim periods within those annual periods. The Company will adopt the new provisions of this accounting standard at the beginning of fiscal year 2017, given that early adoption is not an option. The Company will further study the implications of this statement in order to evaluate the expected impact on the consolidated financial statements. |
Inventories
Inventories | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Inventories [Abstract] | ' | ||||||||
Inventories | ' | ||||||||
-4 | Inventories | ||||||||
Inventories are stated at the lower of cost (weighted average first-in, first-out method) or market. Appropriate consideration is given to deterioration, obsolescence and other factors in evaluating net realizable value. Inventories are comprised of the following: | |||||||||
September 30, | December 31, | ||||||||
2014 | 2013 | ||||||||
(unaudited) | |||||||||
Raw materials | $ | 7,533,000 | $ | 6,386,000 | |||||
Work-in-process | 1,548,000 | 926,000 | |||||||
Finished goods | 6,651,000 | 6,690,000 | |||||||
$ | 15,732,000 | $ | 14,002,000 |
Goodwill_and_Other_Intangible_
Goodwill and Other Intangible Assets | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Goodwill and Other Intangible Assets [Abstract] | ' | ||||||||
Goodwill and Other Intangible Assets | ' | ||||||||
-5 | Goodwill and Other Intangible Assets | ||||||||
The changes in the carrying amount of goodwill and acquired intangible assets for the nine months ended September 30, 2014 are as follows: | |||||||||
Acquired | |||||||||
Goodwill | Intangibles | ||||||||
(unaudited) | |||||||||
Balance at December 31, 2013 | $ | 10,532,000 | $ | 11,943,000 | |||||
Amortization | – | (1,234,000 | ) | ||||||
Foreign currency translation adjustments | (186,000 | ) | (95,000 | ) | |||||
Balance at September 30, 2014 | $ | 10,346,000 | $ | 10,614,000 |
Credit_Risk_and_Allowance_for_
Credit Risk and Allowance for Doubtful Accounts | 9 Months Ended | |
Sep. 30, 2014 | ||
Credit Risk and Allowance for Doubtful Accounts [Abstract] | ' | |
Credit Risk and Allowance for Doubtful Accounts | ' | |
-6 | Credit Risk and Allowance for Doubtful Accounts | |
The Company maintains allowances for doubtful accounts for estimated losses resulting from the inability of our customers to make required payments. This allowance is regularly evaluated by the Company for adequacy by taking into consideration factors such as past experience, credit quality of the customer base, age of the receivable balances, both individually and in the aggregate, and current economic conditions that may affect a customer’s ability to pay. The Company does not accrue interest on past due accounts receivable. Receivables are written off only after all collection attempts have failed and are based on an individual credit evaluation and the specific circumstances of the customer. At September 30, 2014 and December 31, 2013, the allowance for doubtful accounts was $220,000 and $150,000, respectively. | ||
All product returns must be pre-approved, and if approved, customers are subject to a 20% restocking charge. The Company analyzes the rate of historical returns when evaluating the adequacy of the allowance for sales returns, which is included with the allowance for doubtful accounts on our balance sheet. At September 30, 2014 and December 31, 2013, the sales and return allowance was $65,000 and $50,000, respectively. | ||
Accounts receivable are shown net of the combined total of the allowance for doubtful accounts and allowance for sales returns of $285,000 and $200,000 at September 30, 2014 and December 31, 2013, respectively. |
Concentrations_of_Credit_and_O
Concentrations of Credit and Other Risks | 9 Months Ended | |
Sep. 30, 2014 | ||
Concentrations of Credit and Other Risks [Abstract] | ' | |
Concentrations of Credit and Other Risks | ' | |
-7 | Concentrations of Credit and Other Risks | |
In the United States, the Company sells its products and services directly to hospitals and clinics. In all international markets, the Company sells its products to distributors who, in turn, sell to hospitals and clinics. | ||
With respect to accounts receivable, the Company performs credit evaluations of its customers and does not require collateral. No single customer represented greater than 10% of gross accounts receivable as of either September 30, 2014 or December 31, 2013. There have been no material losses on customer receivables. | ||
Revenue by geographic destination as a percentage of total net revenue for the nine month periods ended September 30, 2014 and 2013 was 83% and 85% in the United States and 17% and 15% in international markets, respectively. Revenues are attributable to countries based on location of the customer. No single customer represented greater than 10% of the total net revenue for the three and nine months ended September 30, 2014 and 2013. |
Dependence_on_Key_Suppliers
Dependence on Key Suppliers | 9 Months Ended | |
Sep. 30, 2014 | ||
Dependence on Key Suppliers [Abstract] | ' | |
Dependence on Key Suppliers | ' | |
-8 | Dependence on Key Suppliers | |
The Company purchases certain key components from single-source suppliers. Any significant component delay or interruption could require the Company to qualify new sources of supply, if available, and could have a material adverse effect on the Company’s financial condition and results of operations. | ||
King Pharmaceuticals | ||
The Company purchases its requirements for thrombin (a component in the Hemostat products) under a Thrombin-JMI Supply Agreement entered into with King on January 9, 2007. Under the terms of the Thrombin-JMI Supply Agreement, King agrees to manufacture and supply thrombin to the Company on a non-exclusive basis. The Thrombin-JMI Supply Agreement does not contain any minimum purchase requirements. King agrees to supply the Company with such quantity of thrombin as the Company may order at a fixed price throughout the term of the Thrombin-JMI Supply Agreement as adjusted for inflation, variations in potency and other factors. The Thrombin-JMI Supply Agreement has an initial term of 10 years, followed by successive automatic one-year extensions, subject to termination by the parties under certain circumstances, including: (i) termination by King without cause any time after the fifth anniversary of the date of the Thrombin-JMI Supply Agreement upon five years prior written notice to the Company, and (ii) termination by the Company without cause any time after the fifth anniversary of the date of the Thrombin-JMI Supply Agreement upon five years prior written notice to King provided that the Device Supply Agreement, which the Company also entered into with King on January 9, 2007, has expired on its terms or the parties have agreed to terminate it. |
Commitments_and_Contingencies
Commitments and Contingencies | 9 Months Ended | |
Sep. 30, 2014 | ||
Commitments and Contingencies [Abstract] | ' | |
Commitments and Contingencies | ' | |
-9 | Commitments and Contingencies | |
Boston Scientific Corporation Litigation | ||
On May 16, 2013, the Company filed a patent infringement complaint in the United States District Court for the District of Minnesota against Boston Scientific Corporation (Boston Scientific). The complaint alleged that Boston Scientific infringed three of the Company’s patents concerning rapid exchange guide extension technology by manufacturing and selling its Guidezilla™ guide extension catheter. On July 11, 2013, Boston Scientific filed its answer and counterclaim, alleging the Company’s patents are invalid, that the Guidezilla catheter does not infringe, and that the Company’s manufacture and sale of its GuideLiner catheter violates a U.S. patent owned by Boston Scientific that expired in June 2013. On July 30, 2014, the Company agreed with Boston Scientific to settle the patent lawsuit and counterclaim. As part of the settlement agreement, all litigation relating to guide extension was dismissed and the Company will receive an ongoing royalty from Boston Scientific in exchange for a license of the Company’s patents. The terms of the settlement agreement are confidential. | ||
Governmental Proceedings | ||
On June 28, 2011, the Company received a subpoena from the U.S. Attorney’s Office for the Western District of Texas under the Health Insurance Portability & Accountability Act of 1996 (HIPAA) requesting the production of documents related to Vari-Lase products, and in particular the use of the Vari-Lase Short Kit for the treatment of perforator veins. Subsequently, the Company learned that the U.S. Attorney’s Office commenced a criminal investigation of the same matter. The Vari-Lase Short Kit was sold under a 510(k) clearance for the treatment of incompetence and reflux of superficial veins in the lower extremity from 2007 until it was voluntarily withdrawn from the market in July 2014 with total U.S. sales of approximately $534,000 (0.1% of the Company’s total U.S. sales for such period) and has not been the subject of any reported serious adverse clinical event. On August 14, 2012, the United States District Court for the Western District of Texas unsealed a qui tam complaint that had been filed on November 19, 2010 by Desalle Bui, a former sales employee of the Company, which was the basis for the U.S. Attorney’s civil investigation, to which the federal government, after three extensions of time, elected to intervene. The complaint contained allegations of off-label promotion of Vari-Lase products for the treatment of perforator veins, re-use of single-use Vari-Lase products and kickbacks to physicians, resulting in alleged damages to the government of approximately $20 million. An amended complaint limited to allegations of off-label promotion of the Vari-Lase Short Kit resulting in an unspecified amount of damages and penalties was filed by the U.S. Attorney’s Office in December 2012. On January 22, 2014, the Company agreed with the U.S. Attorney’s Office to settle the civil lawsuit, and the settlement agreement was executed on July 28, 2014. Under the terms of the settlement agreement, the Company made a payment of $520,000, the Company made no admission of fault or liability, and the U.S. Attorney’s Office dismissed the civil lawsuit with prejudice and released all civil claims brought against the Company in the civil lawsuit. Settlement of the civil lawsuit had no effect upon the criminal investigation, which is on-going. | ||
From time to time, the Company is involved in additional legal proceedings arising in the normal course of business. As of the date of this report, the Company is not a party to any legal proceeding not described in this section in which an adverse outcome would reasonably be expected to have a material adverse effect on the Company’s results of operations or financial condition. | ||
King Agreements | ||
On January 9, 2007, the Company entered into a License Agreement and a Device Supply Agreement with King. Under the License Agreement, the Company licensed the exclusive rights to the Company’s products Thrombi-Pad, Thrombi-Gel and Thrombi-Paste to King in exchange for a one-time license fee. Under the Device Supply Agreement, the Company agreed to manufacture the licensed products for sale to King in exchange for an initial payment. The unamortized license fee was $457,000 and $610,000 at September 30, 2014 and December 31, 2013, respectively. Amortization of the deferred revenue will be $51,000 per quarter for the remainder of the 10-year license period. The amortization of license fee was $153,000 for both of the nine month periods ended September 30, 2014 and 2013. |
Income_Taxes
Income Taxes | 9 Months Ended | |
Sep. 30, 2014 | ||
Income Taxes [Abstract] | ' | |
Income Taxes | ' | |
-10 | Income Taxes | |
The Company is subject to income tax in numerous jurisdictions and at various rates and the use of estimates is required in determining the provision for income taxes. For the nine month periods ended September 30, 2014 and 2013, the Company recorded a provision for taxes of $6,033,000 and $3,750,000 on earnings before tax of $14,607,000 and $11,355,000 resulting in an effective income tax rate of 41% and 33%, respectively. The difference between the effective tax rate of 41% for the nine months ended September 30, 2014 and the U.S. federal statutory income tax rate of 34% was due mainly to a change in the valuation allowance against the Company’s deferred Minnesota tax assets discussed below. The difference between the effective tax rate of 33% for the nine months ended September 30, 2013 and the U.S. federal statutory income tax rate of 34% was due mainly to the impact of recognizing $300,000 of research and development credits in the first quarter of 2013 that had been deferred from 2012 pending Congressional action which was completed in January 2013 and the recognition of $53,000 of refundable Ireland research and development credits in the second quarter of 2013. | ||
The Company regularly assesses the likelihood that the deferred tax assets will be recovered from future taxable earnings. The Company considers projected future taxable earnings and ongoing tax planning strategies, and then records a valuation allowance to reduce the carrying value of the net deferred taxes to an amount that is more likely than not to be realized. For the quarter ended September 30, 2014, based upon the Company’s assessment of all available evidence, including estimates of future profitability, the Company’s overall prospects of future business and the apportionment of the Company’s income to the State of Minnesota based on current apportionment methods, the Company determined that it is more likely than not that the Company will not be able to realize all remaining deferred tax assets relating to the Minnesota research and development credits and the Minnesota net operating loss carryforwards prior to their expirations. As a result, the Company recorded additional income tax expense of $867,000 during the quarter ended September 30, 2014 as a discrete adjustment to the valuation allowance for its deferred tax assets, representing 16.7% and 5.9% of pretax income for the three and nine months ended September 30, 2014, respectively. The Company continues to assess the potential realization of deferred tax assets on a quarterly basis. If the Company’s actual results and updated projections vary significantly from the projections used as a basis for this determination, the Company may need to increase or decrease the valuation allowance against the gross deferred tax assets. The Company will adjust earnings for the deferred tax in the period in which the determination is made. | ||
The Company applies ASC 740, Income Taxes, which clarifies the accounting for uncertainty in tax positions recognized in the financial statements. These provisions create a single model to address uncertainty in tax positions and clarify the accounting for income taxes by prescribing the minimum recognition threshold a tax position is required to meet before being recognized in the financial statements. ASC 740 also provides guidance on derecognition, measurement, classification, interest and penalties, accounting in interim periods, disclosure and transition. The Company has recorded an unrecognized tax asset of $1,306,000 and $1,268,000 as of September 30, 2014 and December 31, 2013, respectively. The impact of tax related interest and penalties is recorded as a component of income tax expense. As of September 30, 2014, the Company has recorded $-0- for the payment of tax related interest and there were no tax penalties or interest recognized in the statements of earnings. | ||
The Company is subject to income tax examinations in the U.S. Federal jurisdiction, as well as in the Republic of Ireland and various state jurisdictions. At September 30, 2014, tax years 2011 through 2013 remain open to examination. |
Business_Combinations_and_Asse
Business Combinations and Asset Acquisitions | 9 Months Ended | |
Sep. 30, 2014 | ||
Business Combinations and Asset Acquisitions [Abstract] | ' | |
Business Combinations and Asset Acquisitions | ' | |
-11 | Business Combinations and Asset Acquisitions | |
Northeast Scientific | ||
On September 17, 2013, the Company entered into an eight-year reprocessing services agreement with Northeast Scientific, Inc. (NES), a FDA-registered reprocessor of medical devices, whereby the Company paid NES a non-refundable amount of $500,000 for the exclusive right to offer NES’ reprocessing services in the United States for a commercial medical device. NES is pursuing FDA approval for its reprocessing services for the device. If FDA approval is obtained, the Company is required to pay NES a non-refundable amount of $400,000. The agreement has an annual minimum unit termination clause, allowing NES to terminate the agreement if the Company does not meet certain annual minimums following FDA approval. | ||
The Company accounted for the transaction as a non-business asset acquisition in the third quarter of 2013. In accordance with ASC 805, the purchase price of $900,000 was assigned to an intangible asset and no goodwill was recognized. The Company recorded a $400,000 accrual in the third quarter of 2013 for the payment to be made upon FDA approval, in addition to the $500,000 initial payment. The Company will begin amortizing the intangible asset on a per unit basis over the remaining term of the agreement once the Company begins to send units to NES to be reprocessed following FDA approval. |
Products_and_Services
Products and Services | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Products and Services [Abstract] | ' | ||||||||||||||||
Products and Services | ' | ||||||||||||||||
-12 | Products and Services | ||||||||||||||||
The Company has three product categories as follows: | |||||||||||||||||
· | Catheter products consist principally of catheters used in minimally invasive medical procedures for the diagnosis or treatment of vascular conditions, such as the GuideLiner®catheter used to access discrete regions of the coronary anatomy and the Pronto® extraction catheters used in treating acute myocardial infarction. This category also includes products used in connection with gaining percutaneous access to the vasculature to perform minimally invasive procedures, such as micro-introducer kits. | ||||||||||||||||
· | Hemostat products consist principally of blood clotting products, such as the D-Stat® Dry hemostat, a topical thrombin-based pad with a bandage used to control surface bleeding, and the D-Stat Flowable, a thick yet flowable thrombin-based mixture for preventing bleeding in subcutaneous pockets. This category also includes our line of devices used in radial artery procedures, such as our Accumed™wrist positioning splints and Vasc™ Band inflatable compression bands. | ||||||||||||||||
· | Vein products and services consist principally of the Vari-Lase® endovenous laser, a laser console and procedure kit used for the treatment of varicose veins, and a reprocessing service for the ClosureFAST radiofrequency vein ablation catheter. | ||||||||||||||||
The following tables set forth, for the periods indicated, net revenue by product category along with the percent change from the previous period: | |||||||||||||||||
Three Months Ended September 30, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Net | Percent | Net | Percent | ||||||||||||||
Revenue | Change | Revenue | Change | ||||||||||||||
Catheter products | $ | 21,116,000 | 18 | % | $ | 17,965,000 | 17 | % | |||||||||
Hemostat products | 6,108,000 | 2 | % | 5,962,000 | 7 | % | |||||||||||
Vein products and services | 4,542,000 | 14 | % | 3,999,000 | 11 | % | |||||||||||
Total product revenue | 31,766,000 | 14 | % | 27,926,000 | 14 | % | |||||||||||
License | 163,000 | 96 | % | 83,000 | (5 | %) | |||||||||||
Total revenue | $ | 31,929,000 | 14 | % | $ | 28,009,000 | 14 | % | |||||||||
Nine Months Ended September 30, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Net | Percent | Net | Percent | ||||||||||||||
Revenue | Change | Revenue | Change | ||||||||||||||
Catheter products | $ | 60,675,000 | 17 | % | $ | 52,031,000 | 14 | % | |||||||||
Hemostat products | 18,305,000 | 3 | % | 17,768,000 | 3 | % | |||||||||||
Vein products and services | 13,236,000 | 16 | % | 11,398,000 | 14 | % | |||||||||||
Total product revenue | 92,216,000 | 14 | % | 81,197,000 | 12 | % | |||||||||||
License, royalty and collaboration | 297,000 | 29 | % | 230,000 | (12 | %) | |||||||||||
Total revenue | $ | 92,513,000 | 14 | % | $ | 81,427,000 | 11 | % |
Net_Earnings_per_Share_Tables
Net Earnings per Share (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Net Earnings per Share [Abstract] | ' | ||||||||||||||||
Weighted average common shares outstanding | ' | ||||||||||||||||
Weighted average common shares outstanding for the three and nine months ended September 30, 2014 and 2013 were as follows: | |||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
(unaudited) | (unaudited) | ||||||||||||||||
Weighted average shares outstanding – basic | 16,871,000 | 16,451,000 | 16,827,000 | 16,299,000 | |||||||||||||
Weighted average shares outstanding – diluted | 17,691,000 | 17,067,000 | 17,642,000 | 16,894,000 |
Inventories_Tables
Inventories (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Inventories [Abstract] | ' | ||||||||
Inventories | ' | ||||||||
Inventories are comprised of the following: | |||||||||
September 30, | December 31, | ||||||||
2014 | 2013 | ||||||||
(unaudited) | |||||||||
Raw materials | $ | 7,533,000 | $ | 6,386,000 | |||||
Work-in-process | 1,548,000 | 926,000 | |||||||
Finished goods | 6,651,000 | 6,690,000 | |||||||
$ | 15,732,000 | $ | 14,002,000 |
Goodwill_and_Other_Intangible_1
Goodwill and Other Intangible Assets (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Goodwill and Other Intangible Assets [Abstract] | ' | ||||||||
Goodwill and acquired intangible assets | ' | ||||||||
The changes in the carrying amount of goodwill and acquired intangible assets for the nine months ended September 30, 2014 are as follows: | |||||||||
Acquired | |||||||||
Goodwill | Intangibles | ||||||||
(unaudited) | |||||||||
Balance at December 31, 2013 | $ | 10,532,000 | $ | 11,943,000 | |||||
Amortization | – | (1,234,000 | ) | ||||||
Foreign currency translation adjustments | (186,000 | ) | (95,000 | ) | |||||
Balance at September 30, 2014 | $ | 10,346,000 | $ | 10,614,000 |
Products_and_Services_Tables
Products and Services (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Products and Services [Abstract] | ' | ||||||||||||||||
Revenue by product category | ' | ||||||||||||||||
The following tables set forth, for the periods indicated, net revenue by product category along with the percent change from the previous period: | |||||||||||||||||
Three Months Ended September 30, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Net | Percent | Net | Percent | ||||||||||||||
Revenue | Change | Revenue | Change | ||||||||||||||
Catheter products | $ | 21,116,000 | 18 | % | $ | 17,965,000 | 17 | % | |||||||||
Hemostat products | 6,108,000 | 2 | % | 5,962,000 | 7 | % | |||||||||||
Vein products and services | 4,542,000 | 14 | % | 3,999,000 | 11 | % | |||||||||||
Total product revenue | 31,766,000 | 14 | % | 27,926,000 | 14 | % | |||||||||||
License | 163,000 | 96 | % | 83,000 | (5 | %) | |||||||||||
Total revenue | $ | 31,929,000 | 14 | % | $ | 28,009,000 | 14 | % | |||||||||
Nine Months Ended September 30, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Net | Percent | Net | Percent | ||||||||||||||
Revenue | Change | Revenue | Change | ||||||||||||||
Catheter products | $ | 60,675,000 | 17 | % | $ | 52,031,000 | 14 | % | |||||||||
Hemostat products | 18,305,000 | 3 | % | 17,768,000 | 3 | % | |||||||||||
Vein products and services | 13,236,000 | 16 | % | 11,398,000 | 14 | % | |||||||||||
Total product revenue | 92,216,000 | 14 | % | 81,197,000 | 12 | % | |||||||||||
License, royalty and collaboration | 297,000 | 29 | % | 230,000 | (12 | %) | |||||||||||
Total revenue | $ | 92,513,000 | 14 | % | $ | 81,427,000 | 11 | % |
Net_Earnings_per_Share_Details
Net Earnings per Share (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Net Earnings per Share [Abstract] | ' | ' | ' | ' |
Weighted average shares outstanding - basic (in shares) | 16,871,000 | 16,451,000 | 16,827,000 | 16,299,000 |
Weighted average shares outstanding - diluted (in shares) | 17,691,000 | 17,067,000 | 17,642,000 | 16,894,000 |
Revenue_Recognition_Details
Revenue Recognition (Details) | 9 Months Ended |
Sep. 30, 2014 | |
Revenue Recognition [Abstract] | ' |
Restocking charge (in hundredths) | 20.00% |
Thrombi Pad [Member] | ' |
Revenue Recognition, Amortization of License Fee [Line Items] | ' |
Years to amortize license fees | '10 years |
Thrombi Gel [Member] | ' |
Revenue Recognition, Amortization of License Fee [Line Items] | ' |
Years to amortize license fees | '10 years |
Thrombi Paste [Member] | ' |
Revenue Recognition, Amortization of License Fee [Line Items] | ' |
Years to amortize license fees | '10 years |
Nicolai, GmbH [Member] | ' |
Revenue Recognition, Amortization of License Fee [Line Items] | ' |
Years to amortize license fees | '5 years |
Inventories_Details
Inventories (Details) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Inventories [Abstract] | ' | ' |
Raw materials | $7,533,000 | $6,386,000 |
Work-in-process | 1,548,000 | 926,000 |
Finished goods | 6,651,000 | 6,690,000 |
Inventory, Total | $15,732,000 | $14,002,000 |
Goodwill_and_Other_Intangible_2
Goodwill and Other Intangible Assets (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Goodwill [Abstract] | ' | ' | ' | ' |
Beginning balance | ' | ' | $10,532,000 | ' |
Foreign currency translation adjustments | ' | ' | -186,000 | ' |
Ending balance | 10,346,000 | ' | 10,346,000 | ' |
Acquired Intangibles [Abstract] | ' | ' | ' | ' |
Beginning balance | ' | ' | 11,943,000 | ' |
Amortization | -410,000 | -404,000 | -1,234,000 | -1,162,000 |
Foreign currency translation adjustments | ' | ' | -95,000 | ' |
Ending balance | $10,614,000 | ' | $10,614,000 | ' |
Credit_Risk_and_Allowance_for_1
Credit Risk and Allowance for Doubtful Accounts (Details) (USD $) | 9 Months Ended | |
Sep. 30, 2014 | Dec. 31, 2013 | |
Valuation and Qualifying Accounts Disclosure [Line Items] | ' | ' |
Reserves for accounts receivable, net | $285,000 | $200,000 |
Restocking charge (in hundredths) | 20.00% | ' |
Allowance for Doubtful Accounts [Member] | ' | ' |
Valuation and Qualifying Accounts Disclosure [Line Items] | ' | ' |
Reserves for accounts receivable, net | 220,000 | 150,000 |
Allowance for Sales Returns [Member] | ' | ' |
Valuation and Qualifying Accounts Disclosure [Line Items] | ' | ' |
Reserves for accounts receivable, net | $65,000 | $50,000 |
Concentrations_of_Credit_and_O1
Concentrations of Credit and Other Risks (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Dec. 31, 2013 | |
Concentration Risk [Line Items] | ' | ' | ' | ' | ' |
Threshold for reporting customers revenues by customer (in hundredths) | 10.00% | 10.00% | 10.00% | 10.00% | ' |
Threshold for reporting customers gross receivables by customer (in hundredths) | ' | ' | 10.00% | ' | 10.00% |
United States [Member] | ' | ' | ' | ' | ' |
Concentration Risk [Line Items] | ' | ' | ' | ' | ' |
Concentration risk, percentage (in hundredths) | ' | ' | 83.00% | 85.00% | ' |
International Markets [Member] | ' | ' | ' | ' | ' |
Concentration Risk [Line Items] | ' | ' | ' | ' | ' |
Concentration risk, percentage (in hundredths) | ' | ' | 17.00% | 15.00% | ' |
Dependence_on_Key_Suppliers_De
Dependence on Key Suppliers (Details) | 9 Months Ended |
Sep. 30, 2014 | |
Kings Pharmaceuticals [Abstract] | ' |
Initial agreement period | '10 years |
Contract extension period | '1 year |
Period of written notice to supplier | '5 years |
Commitments_and_Contingencies_
Commitments and Contingencies (Details) (USD $) | 3 Months Ended | 9 Months Ended | 0 Months Ended | 91 Months Ended | 9 Months Ended | ||||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Jul. 28, 2014 | Jul. 31, 2014 | Sep. 30, 2014 | Sep. 30, 2013 | Dec. 31, 2013 | |
Governmental Proceedings [Member] | Governmental Proceedings [Member] | King Agreements [Member] | King Agreements [Member] | King Agreements [Member] | |||||
Vari-Lase [Member] | |||||||||
Governmental Proceedings [Abstract] | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Product revenue | $31,766,000 | $27,926,000 | $92,216,000 | $81,197,000 | ' | $534,000 | ' | ' | ' |
Total U.S. sales, percentage (in hundredths) | ' | ' | ' | ' | ' | 0.10% | ' | ' | ' |
Alleged damages from product defects to government | ' | ' | ' | ' | ' | 20,000,000 | ' | ' | ' |
Terms of settlement of litigation | ' | ' | ' | ' | 520,000 | ' | ' | ' | ' |
King Agreements [Abstract] | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Unamortized license fee | ' | ' | ' | ' | ' | ' | 457,000 | ' | 610,000 |
Future amortization of deferred revenue per quarter | ' | ' | ' | ' | ' | ' | 51,000 | ' | ' |
Amortization period for license fee | ' | ' | ' | ' | ' | ' | '10 years | ' | ' |
Amortization of license fee | ' | ' | ' | ' | ' | ' | $153,000 | $153,000 | ' |
Income_Taxes_Details
Income Taxes (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Dec. 31, 2013 | Jun. 30, 2013 | |
Ireland Tax Authority [Member] | ||||||
Income Taxes [Abstract] | ' | ' | ' | ' | ' | ' |
Income tax expense (benefit) | $2,634,000 | $1,352,000 | $6,033,000 | $3,750,000 | ' | ' |
Earnings before income tax | 5,204,000 | 4,024,000 | 14,607,000 | 11,355,000 | ' | ' |
Effective income tax rate (in hundredths) | ' | ' | 41.00% | 33.00% | ' | ' |
Federal statutory income tax rate (in hundredths) | ' | ' | 34.00% | 34.00% | ' | ' |
Additional income tax expense | 867,000 | ' | ' | ' | ' | ' |
Percentage of pretax income (in hundredths) | 16.70% | ' | 5.90% | ' | ' | ' |
Unrecognized income tax asset | 1,306,000 | ' | 1,306,000 | ' | 1,268,000 | ' |
Tax related interest expense | ' | ' | 0 | ' | ' | ' |
Tax related penalties expense | ' | ' | 0 | ' | ' | ' |
Tax Credit Carryforward [Line Items] | ' | ' | ' | ' | ' | ' |
Research and development, tax credit | ' | $300,000 | ' | $300,000 | ' | $53,000 |
Business_Combinations_and_Asse1
Business Combinations and Asset Acquisitions (Details) (Northeast Scientific [Member], USD $) | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 2013 | |
Purchase price allocation [Abstract] | ' | ' |
Term of agreement | '8 years | ' |
Amount paid for exclusive rights | ' | $500,000 |
Acquired finite-lived intangible asset, amount | 900,000 | ' |
Prior Approval [Member] | ' | ' |
Purchase price allocation [Abstract] | ' | ' |
Amount paid for exclusive rights | 500,000 | ' |
After Approval [Member] | ' | ' |
Purchase price allocation [Abstract] | ' | ' |
Amount paid for exclusive rights | $400,000 | ' |
Products_and_Services_Details
Products and Services (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Category | Category | |||
Product Information [Line Items] | ' | ' | ' | ' |
Number of product categories | 3 | ' | 3 | ' |
Total revenue | $31,929,000 | $28,009,000 | $92,513,000 | $81,427,000 |
Total revenue percentage change (in hundredths) | 14.00% | 14.00% | 14.00% | 11.00% |
Catheter Products [Member] | ' | ' | ' | ' |
Product Information [Line Items] | ' | ' | ' | ' |
Total revenue | 21,116,000 | 17,965,000 | 60,675,000 | 52,031,000 |
Total revenue percentage change (in hundredths) | 18.00% | 17.00% | 17.00% | 14.00% |
Hemostat Products [Member] | ' | ' | ' | ' |
Product Information [Line Items] | ' | ' | ' | ' |
Total revenue | 6,108,000 | 5,962,000 | 18,305,000 | 17,768,000 |
Total revenue percentage change (in hundredths) | 2.00% | 7.00% | 3.00% | 3.00% |
Vein Products and Services [Member] | ' | ' | ' | ' |
Product Information [Line Items] | ' | ' | ' | ' |
Total revenue | 4,542,000 | 3,999,000 | 13,236,000 | 11,398,000 |
Total revenue percentage change (in hundredths) | 14.00% | 11.00% | 16.00% | 14.00% |
Total Product Revenue [Member] | ' | ' | ' | ' |
Product Information [Line Items] | ' | ' | ' | ' |
Total revenue | 31,766,000 | 27,926,000 | 92,216,000 | 81,197,000 |
Total revenue percentage change (in hundredths) | 14.00% | 14.00% | 14.00% | 12.00% |
License, Royalty and Collaboration [Member] | ' | ' | ' | ' |
Product Information [Line Items] | ' | ' | ' | ' |
Total revenue | $163,000 | $83,000 | $297,000 | $230,000 |
Total revenue percentage change (in hundredths) | 96.00% | -5.00% | 29.00% | -12.00% |