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VOLC > SEC Filings for VOLC > Form 10-Q on 7-Nov-2012All Recent SEC Filings

Show all filings for VOLCANO CORP

Form 10-Q for VOLCANO CORP


7-Nov-2012

Quarterly Report


Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

Forward-looking statements: This quarterly report on Form 10-Q ("Quarterly Report") contains forward-looking statements regarding future events and our future results that are based on current expectations, estimates, forecasts, and projections about the industries in which we operate and the beliefs and assumptions of our management. In some cases, you can identify these "forward-looking statements" by words like "may," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of those words and other comparable words. These statements include, but are not limited to, those concerning the following: our intentions, beliefs and expectations regarding our future financial performance, anticipated growth, trends in our business, trends in the medical field related to our products and technology, and the performance and competitive advantages of our products; our beliefs with respect to the usefulness of anticipated clinical data; the timing and success of our clinical trials, data presentations, regulatory submissions and anticipated product launches; our belief that our cash and cash equivalents and available-for-sale investments will be sufficient to satisfy our anticipated cash requirements; our belief that our current and planned facilities are sufficient for our business; our operating results; timing, costs and outcomes of current or future litigation; our expectations regarding our revenues and costs of producing our products; our expectations regarding our customers and distributors; and our intentions, beliefs and expectations regarding market penetration and expansion efforts. These statements are not guarantees of future performance or events. Our actual results may differ materially from those discussed here. For a detailed discussion of the risks and uncertainties that could contribute to such differences see the "Risk Factors" section in Part II, Item 1A of this Quarterly Report and elsewhere throughout this Quarterly Report and in any other documents incorporated by reference into this Quarterly Report. Any forward-looking statement speaks only as of the date on which it is made, and except as required by law, we undertake no obligation to update forward-looking statements to reflect events or circumstances occurring after the date of this Quarterly Report.
Overview
We design, develop, manufacture and sell a broad suite of precision guided therapy tools including intravascular ultrasound, or IVUS, and fractional flow reserve, or FFR, products. We believe that these products enhance the diagnosis and treatment of vascular heart disease by improving the efficiency and efficacy of existing percutaneous interventional, or PCI, therapy procedures in the coronary or peripheral arteries. We market our products to physicians and technicians who perform PCI procedures in hospitals and to other personnel who make purchasing decisions on behalf of hospitals.
Our products consist of multi-modality consoles which are marketed as stand-alone units or as customized units that can be integrated into a variety of hospital-based interventional surgical suites called catheterization laboratories, or cath labs. We have developed customized cath lab versions of these consoles and are developing additional functionality options as part of our cath lab integration initiative. Our consoles have been designed to serve as a multi-modality platform for our phased array and rotational IVUS catheters, FFR pressure wires, image-guided therapy catheters and Medtronic's Pioneer reentry device. Our IVUS products include single-procedure disposable phased array and rotational IVUS imaging catheters, the VIBE RX image-guided therapy device, and additional functionality options such as virtual histology, or VH, IVUS tissue characterization and ChromaFlo stent apposition analysis. Our FFR offerings can be accessed through our multi-modality platforms, and we also provide FFR-only consoles. Our FFR disposables are single-procedure disposable pressure and flow guide wires used to measure the pressure and flow characteristics of blood around plaque enabling physicians to gauge the plaque's physiological impact on blood flow and pressure.
We are developing additional offerings for integration into the platform, including adenosine-free Instant wave-free ratio FFR, or iFR, forward-looking IVUS, or FL.IVUS, catheters, Forward-Looking Intra-Cardiac Echo, or FL.ICE, catheters, Focal Acoustic Computed Tomography, or FACT, catheters, and ultra-high resolution Optical Coherence Tomography, or OCT, systems and catheters. Our Valet Micro catheter received 510(k) clearance in January 2012 and CE Mark approval in August 2012. Our Visions® PV .035 catheter received 510(k) clearance in September 2012 and CE Mark approval in August 2012. Our Short Tip EEP products received 510(k) clearance in April 2012 and CE Mark approval in August 2012.
Through Axsun Technologies, Inc., or Axsun, one of our wholly owned subsidiaries, we also develop and manufacture optical monitors for the telecommunications industry, laser and non-laser light sources, and optical engines used in the medical OCT imaging systems and advanced photonic components and sub-systems used in spectroscopy and other industrial applications. We believe Axsun's proprietary OCT technology will provide us competitive advantages in the invasive imaging sector.
We have infrastructure in the U.S., Europe, Japan and Costa Rica. Our corporate office is located in California, U.S. Our manufacturing operations are located in California and Massachusetts, U.S. In addition, during the second quarter of 2012, we received FDA clearance and commenced manufacturing of disposables at our new plant in Costa Rica. We have research and development facilities in California, Massachusetts, Ohio and Georgia. We have sales offices in the U.S. and Japan; sales and distribution offices in Belgium and South Africa; and third-party distribution facilities in Japan.


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We have focused on building our domestic and international sales and marketing infrastructure to market our products to physicians and technicians who perform PCI procedures in hospitals and to other personnel who make purchasing decisions on behalf of hospitals. We sell our products directly to customers in the U.S., Japan, certain European markets and South Africa. We utilize distributors in other geographic areas, who are also involved in product launch planning, education and training, physician support and clinical trial management. At September 30, 2012, we had a worldwide installed base of over 7,500 consoles. We intend to grow and leverage this installed base to drive recurring sales of our single-procedure disposable catheters and guide wires. In the nine months ended September 30, 2012, the sale of our single-procedure disposable catheters and guide wires accounted for $221.3 million, or 81.6% of our medical segment revenues, a $26.0 million, or 13.3% increase from the same period in 2011, in which the sale of our single-procedure disposable catheters and guide wires accounted for $195.3 million, or 80.9% of our medical segment revenues. In the nine months ended September 30, 2012 and 2011, 46.1% and 47.4%, respectively, of our revenues and 23.1% and 22.3%, respectively, of our operating expenses were denominated in various non-U.S. dollar currencies, primarily the Japanese yen, or yen, and the euro. We expect that a significant portion of our revenue and operating expenses will continue to be denominated in non-U.S. dollar currencies. As a result, we are subject to risks related to fluctuations in foreign currency exchange rates, which could affect our operating results in the future. If our yen or euro denominated sales exceed our yen or euro denominated costs, and the U.S. dollar strengthens relative to the yen or euro, there is an adverse effect on our results of operations. Conversely, if the U.S. dollar weakens relative to the yen or euro, there is a positive effect on our results of operations. For example, the average exchange rate of one U.S. dollar to yen decreased 1.7% from 80.40 in the nine months ended September 30, 2011 to 79.03 in the nine months ended September 30, 2012, which resulted in a net positive impact to our operating results in the amount of approximately $1.1 million. On the other hand, the average exchange rate of one euro to U.S. dollar decreased 9.9% from 1.42 in the nine months ended September 30, 2011 to 1.28 in the nine months ended September 30, 2012, which resulted in a net negative impact to our operating results in the amount of approximately $2.4 million.
We use third-party manufacturing partners to produce circuit boards and mechanical sub-assemblies used in the manufacture of our consoles. We also use third-party manufacturing partners for certain proprietary components used in the manufacture of our single-procedure disposable products. We perform incoming inspection on these circuit boards, mechanical sub-assemblies and components, assemble them into finished products, and test the final product to assure quality control. We do not carry significant inventory of transducers, substrates or scanner subassemblies. If we had to change suppliers, we expect that it would take 6 to 24 months to identify appropriate suppliers, complete design work and undertake the necessary inspections and testing before the new transducers, substrates and subassemblies would be available. External Factors

In September 2009, published findings from the Fractional Flow Reserve versus Angiography for Multivessel
Evaluation, or FAME, study demonstrated that patients in the study with multi-vessel coronary artery disease who were treated by FFR guidance had a 34% reduction in death and myocardial infarction compared to angiographic guidance alone. In August 2012, the results of the Fractional Flow Reserve-Guided PCI vs. Medical Therapy in Stable Coronary Disease, or FAME 2, study were published in the New England Journal of Medicine. FAME 2 showed that patients receiving PCI with proven ischemia by FFR had 66% fewer primary endpoint events including death, myocardial infarction and urgent vascularization's than those patients treated with optimal medical therapy alone. We believe these findings will continue to drive the growth and adoption of our disposable FFR wire products.

The Patient Protection and Affordable Care Act and Health Care and Education Affordability Reconciliation Act were enacted into law in the U.S. on March 23, 2010. The legislation imposes on medical device manufacturers a 2.3 percent excise tax on U.S. sales of Class I, II and III medical devices beginning January 1, 2013. We are continuing to evaluate this legislation and its potential impact on the Company and it may adversely affect our business and results of operations.
The economic conditions in many countries and regions where we generate our revenues remain uncertain. The challenging global economic conditions have also led to concerns over the solvency of certain European Union member states, including Greece, Ireland, Italy, Portugal and Spain. As of September 30, 2012, the total outstanding accounts receivable from customers in these countries was less than 4% of our total outstanding accounts receivable. If our customers do not obtain or do not have access to the necessary capital to operate their businesses, or are otherwise adversely affected by any deterioration in national and worldwide economic conditions, this could result in reductions in the sales of our products, longer sales cycles and slower adoption of new technologies by our customers, which would materially and adversely affect our business. In addition, our customers' and suppliers' liquidity, capital resources and credit may be adversely affected by their relative ability or inability to obtain capital and credit, which could adversely affect our ability to collect on our outstanding invoices and lengthen our


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collection cycles, or limit our timely access to important sources of raw materials necessary for the manufacture of our consoles and catheters. In addition, the political unrest in the Middle East may have adverse consequences to the global economy or to our customers in the Middle East, which could negatively impact our business. Uncertainty about future economic conditions may make it more difficult for us to forecast operating results and to make decisions about future investments. For further discussion, see "Risk Factors-General national and worldwide economic conditions may materially and adversely affect our financial performance and results of operations." Financial Operations Overview
The following is a description of the primary components of our revenues and expenses.
Revenues. We derive our revenues from two reporting segments: medical and industrial. Our medical segment represents our core business, in which we derive revenues primarily from the sale of our consoles and single-procedure disposables. Our industrial segment derives revenues related to the sales of micro-optical spectrometers and optical channel monitors to telecommunications and other industrial companies. In the nine months ended September 30, 2012, we generated $279.4 million of revenues which is composed of $271.2 million from our medical segment and $8.2 million from our industrial segment. In the nine months ended September 30, 2012, 10.5% of our medical segment revenues were derived from the sale of our consoles, as compared with 12.2% in the nine months ended September 30, 2011. In the nine months ended September 30, 2012, IVUS single-procedure disposables accounted for 56.7% of our medical segment revenues, compared to 61.1% during the same period in 2011, while in the nine months ended September 30, 2012, 25.0% of our medical segment revenues were derived from the sale of our FFR single-procedure disposables, as compared with 19.9% in the nine months ended September 30, 2011. Other revenues consist primarily of revenue from rental revenues, service and maintenance revenues, other medical revenues, shipping and handling revenues, sales of distributed products, spare parts sales, and license fees.
We expect to continue to experience variability in our quarterly revenues from console sales due in part to the timing of hospital capital equipment purchasing decisions. Further, we expect variability of our revenues based on the timing of our new product introductions, which may cause our customers to delay their purchasing decisions until the new products are commercially available.

Our medical segment sales are generated by our direct sales representatives or through independent distributors and are shipped throughout the world from facilities in California, Massachusetts, Belgium, Japan and South Africa. Our industrial segment sales are generated by our direct sales representatives or through independent distributors and these products are shipped primarily to telecommunications and industrial companies domestically and abroad from our facility in Massachusetts.
Cost of Revenues. Cost of revenues consists primarily of material costs for the products that we sell and other costs associated with our manufacturing process, such as personnel costs, rent, depreciation related to our manufacturing equipment and utilities. In addition, cost of revenues includes depreciation of company-owned consoles, royalty expenses for licensed technologies included in our products, service costs, provisions for warranty, distribution, freight and packaging costs and stock-based compensation expense related to manufacturing employees. We expect a trend of improvement in our gross margin for IVUS and FFR products if we are successful in our ongoing efforts to streamline and improve our manufacturing processes, increase production volumes and transition a greater percentage of manufacturing operations to Costa Rica. Selling, General and Administrative. Selling, general and administrative expenses consist primarily of salaries and other related costs for personnel serving the sales, administrative and marketing functions. Other costs include stock-based compensation expense, professional fees for legal and accounting services, travel and entertainment expenses, facility costs, trade shows, training and other promotional expenses. Due to ongoing litigation, legal expenses tend to be somewhat unpredictable in their timing and amount. We expect that our selling, general and administrative expenses will increase as we continue to expand our sales force and marketing efforts and invest in the necessary infrastructure to support our continued growth.
Research and Development. Research and development expenses consist primarily of salaries and related expenses for personnel, consultants, prototype materials, clinical studies, depreciation, regulatory filing fees, certain legal costs related to our intellectual property and stock-based compensation expense. We expense research and development costs as incurred. Due to product development timelines, research and development costs tend to be distributed unevenly between the periods. We expect our research and development expenses to increase as we continue to develop our products and technologies.
Amortization of Intangibles. We amortize intangible assets, consisting of our acquired developed technology, licenses, customer relationships, assembled workforce, patents and trademarks, using the straight-line method over their estimated useful lives of up to 20 years. These assets are regularly tested for impairment and abandonment.


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Interest Income. Interest income is comprised of interest income earned from our cash and cash equivalents and our short-term and long-term available-for-sale investments.
Interest Expense. Interest expense is primarily comprised of interest expense related to our convertible debt, including coupon interest, accretion of debt discount, and amortization of issuance costs, offset by interest capitalization related to the Costa Rica plant construction, before the plant was placed into service in the second quarter of 2012, and our global Enterprise Resource Planning, or ERP, system implementation.
Exchange Rate Gain (Loss). Exchange rate loss is comprised of foreign currency transaction and remeasurement gains and losses, net, and the effect of changes in value and net settlements of our foreign currency forward contracts. Income Tax Expense. Our effective tax rate is a blended rate resulting from the composition of taxable income in the global jurisdictions in which we conduct business. We apply the "with and without method - direct effects only", in accordance with authoritative guidance, with respect to recognition of stock option excess tax benefits within stockholders equity (additional paid in capital). Therefore, provision for domestic income taxes is determined utilizing projected federal and state taxable income before the application of deductible excess tax benefits attributable to stock option exercises.

The Company carries a valuation allowance on net operating loss and other deferred tax assets in certain international jurisdictions. Realization is dependent on generating sufficient taxable income and other available positive and negative evidence. Management's assessment of the recoverability of these deferred tax assets may increase in the near term based on estimates of future taxable income in these specific jurisdictions, which may result in a reduction in the related valuation allowance. If the objective and quantitative criteria are met, a reduction of the valuation allowance by $3 million to $5 million could occur as soon as the fourth quarter of 2012.

Results of Operations

The following table sets forth items derived from our unaudited condensed
consolidated statements of operations for the three months ended September 30,
2012 and 2011, presented in both absolute dollars (in thousands) and as a
percentage of revenues:

                                          Three Months Ended September 30,                 Change
                                            2012                    2011                $          %
Revenues                            $ 93,656     100.0  %   $ 85,767     100.0  %   $ 7,889       9.2  %
Cost of revenues, excluding
amortization of intangibles           33,248      35.5        29,538      34.4        3,710      12.6
Gross profit                          60,408      64.5        56,229      65.6        4,179       7.4
Operating expenses:
Selling, general and administrative   40,699      43.5        36,034      42.0        4,665      12.9
Research and development              13,032      13.9        13,928      16.2         (896 )    (6.4 )
Amortization of intangibles              710       0.8           860       1.0         (150 )   (17.4 )
Total operating expenses              54,441      58.2        50,822      59.2        3,619       7.1
Operating income                       5,967       6.3         5,407       6.4          560      10.4
Interest income                          223       0.2           226       0.3           (3 )    (1.3 )
Interest expense                      (1,844 )    (2.0 )      (1,834 )    (2.1 )        (10 )     0.5
Exchange rate gain (loss)               (218 )    (0.2 )        (502 )    (0.6 )        284     (56.6 )
Other income (expense), net              (23 )       -             -         -          (23 )       -
Income before income taxes             4,105       4.3         3,297       4.0          808      24.5
Income tax expense                     2,130       2.3           669       0.8        1,461     218.4
Net income                          $  1,975       2.0  %   $  2,628       3.2  %   $  (653 )   (24.8 )%

The following table sets forth items derived from our unaudited condensed consolidated statements of operations for the nine months ended September 30, 2012 and 2011, presented in both absolute dollars (in thousands) and as a percentage of revenues:


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                                          Nine Months Ended September 30,                   Change
                                           2012                     2011                $            %
Revenues                          $ 279,389     100.0  %   $ 250,798     100.0  %   $ 28,591        11.4  %
Cost of revenues, excluding
amortization of intangibles          94,797      33.9         84,175      33.6        10,622        12.6
Gross profit                        184,592      66.1        166,623      66.4        17,969        10.8
Operating expenses:
Selling, general and
administrative                      127,035      45.5        106,982      42.7        20,053        18.7
Research and development             40,560      14.5         40,337      16.1           223         0.6
Amortization of intangibles           2,470       0.9          2,572       1.0          (102 )      (4.0 )
Total operating expenses            170,065      60.9        149,891      59.8        20,174        13.5
Operating income                     14,527       5.2         16,732       6.6        (2,205 )     (13.2 )
Interest income                         656       0.2            701       0.3           (45 )      (6.4 )
Interest expense                     (4,993 )    (1.8 )       (5,895 )    (2.4 )         902       (15.3 )
Exchange rate gain (loss)              (319 )    (0.1 )       (1,181 )    (0.5 )         862       (73.0 )
Other income (expense), net             (31 )       -             (2 )       -           (29 )   1,450.0
Income before income taxes            9,840       3.5         10,355       4.0          (515 )      (5.0 )
Income tax expense                    4,295       1.5          1,684       0.7         2,611       155.0
Net income                        $   5,545       2.0  %   $   8,671       3.3  %   $ (3,126 )     (36.1 )%

The following table sets forth our revenues by segment and product expressed as dollar amounts (in thousands) and the changes in revenues between the specified periods expressed as percentages:

                         Three Months Ended             Change              Nine Months Ended              Change
                           September 30,                                      September 30,
                         2012           2011          $          %         2012          2011           $           %
Medical segment:
Consoles             $     9,679     $  9,709     $   (30 )   (0.3 )%   $  28,529     $  29,420     $   (891 )    (3.0 )%
Single-procedure
disposables:
IVUS                      48,574       49,760      (1,186 )   (2.4 )      153,683       147,384        6,299       4.3
FFR                       24,585       16,653       7,932     47.6         67,652        47,954       19,698      41.1
Other                      7,825        6,796       1,029     15.1         21,286        16,565        4,721      28.5
Sub-total medical
segment                   90,663       82,918       7,745      9.3        271,150       241,323       29,827      12.4
Industrial segment:        2,993        2,849         144      5.1          8,239         9,475       (1,236 )   (13.0 )
                     $    93,656     $ 85,767     $ 7,889      9.2  %   $ 279,389     $ 250,798     $ 28,591      11.4  %

The following table sets forth our revenues by geography expressed as dollar amounts (in thousands) and the changes in revenues in the specified periods expressed as percentages:

                         Three Months Ended             Change              Nine Months Ended              Change
                           September 30,                                      September 30,
                         2012           2011          $          %         2012          2011           $           %
Revenues (1):
United States        $    44,083     $ 38,964     $ 5,119     13.1  %   $ 130,152     $ 113,201     $ 16,951     15.0  %
Japan                     29,699       26,599       3,100     11.7         90,025        76,406       13,619     17.8
Europe, the Middle
East and Africa           13,491       14,637      (1,146 )   (7.8 )       42,507        45,534       (3,027 )   (6.6 )
Rest of world              6,383        5,567         816     14.7         16,705        15,657        1,048      6.7
                     $    93,656     $ 85,767     $ 7,889      9.2  %   $ 279,389     $ 250,798     $ 28,591     11.4  %


 _______________________


(1) Revenues are attributed to geographies based on the location of the customer, except for shipments to original equipment manufacturers, which are attributed to the country of origin of the equipment distributed.


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Comparison of Three Months Ended September 30, 2012 and 2011 Revenues. Overall, the increase in the medical segment revenue in the three months ended September 30, 2012 as compared with the same period in 2011 was driven by increased demand for our disposables, as well as higher revenues resulting from our direct sales efforts in Japan, partially offset by decreases in our revenues in Southern Europe, in particular Spain where we were in the process of transitioning from a distributor to a direct sales model. Additionally, the increases in FFR disposable revenues were primarily due to increased adoption of the technology based on clinical study data. The decreases in IVUS disposable revenues were primarily due to the reimbursement decline in Japan and decrease in revenue in Spain due to the transition to a direct sales model. The increase in other revenues is primarily due to higher sales of third-party products and higher service contract and rental revenues. We . . .

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