The following discussion and analysis of our financial condition and results of
operations should be read in conjunction with the unaudited condensed
consolidated financial statements and the related notes thereto included
elsewhere in this Quarterly Report on Form 10-Q and the audited consolidated
financial statements and notes thereto and management's discussion and analysis
of financial condition and results of operations for the year ended December 31,
2019, included in our Annual Report on Form 10-K filed with the Securities and
Exchange Commission ("SEC") on February 26, 2020.
This Quarterly Report on Form 10-Q contains "forward-looking statements" within
the meaning of Section 21E of the Securities Exchange Act of 1934, as amended
(the "Exchange Act"). In some cases, you can identify these statements by
forward-looking words such as "may," "will," "expect," "believe," "anticipate,"
"intend," "could," "should," "estimate," or "continue," and similar expressions
or variations. Such forward-looking statements are subject to risks,
uncertainties and other factors that could cause actual results and the timing
of certain events to differ materially from future results and timing  expressed
or implied by such forward-looking statements. Factors that could cause or
contribute to such differences include, but are not limited to, those identified
below, and those discussed in the section titled "Risk Factors" in Part I, Item
1A of our Annual Report on Form 10-K for the year ended December 31, 2019. The
forward-looking statements in this Quarterly Report on Form 10-Q represent our
views as of the date of this Quarterly Report on Form 10-Q. Except as may be
required by law, we assume no obligation to update these forward-looking
statements or the reasons that results could differ from these forward-looking
statements. You should, therefore, not rely on these forward-looking statements
as representing our views as of any date subsequent to the date of this
Quarterly Report on Form 10-Q.
Overview
Penumbra is a global healthcare company focused on innovative therapies. We
design, develop, manufacture and market novel products and have a broad
portfolio that addresses challenging medical conditions in markets with
significant unmet need. Our team focuses on developing, manufacturing and
marketing novel products for use by specialist physicians and healthcare
providers to drive improved clinical outcomes. We believe that the
cost-effectiveness of our products is attractive to our customers.
Since our founding in 2004, we have invested heavily in our product development
capabilities in our major markets: neuro and vascular. We have successfully
developed, obtained regulatory clearance or approval for, and introduced
products into the neurovascular market since 2007, vascular market since 2013
and neurosurgical market since 2014, respectively. We continue to expand our
portfolio of product offerings, while developing and iterating on our currently
available products.
We expect to continue to develop and build our portfolio of products, including
our thrombectomy, embolization and access technologies. Generally, when we
introduce a next generation product or a new product designed to replace a
current product, sales of the earlier generation product or the product replaced
decline. Our research and development activities are centered around the
development of new products and clinical activities designed to support our
regulatory submissions and demonstrate the effectiveness of our products.
To address the challenging and significant clinical needs of our two key
markets, we developed products that fall into the following broad product
offering families:
Our neuro products fall into five broad product families:
•Neuro thrombectomy - Penumbra System, including Penumbra JET, ACE and the 3D
Revascularization Device, Penumbra ENGINE and other components and accessories
•Neuro embolization - Penumbra SMART COIL, Penumbra Coil 400, POD400 and PAC400
•Neuro access - delivery catheters, consisting of Neuron, Neuron MAX, Select,
BENCHMARK, DDC and PX SLIM
•Neurosurgical - Artemis Neuro Evacuation Device
•Rehabilitation Tools - REAL Immersive System
Our vascular products fall into two broad product families:
•Vascular thrombectomy - Indigo System designed for mechanical thrombectomy,
including aspiration catheters, separators, aspiration pump and accessories
•Vascular embolization - Ruby Coil System, LANTERN Delivery Microcatheter and
the POD System (POD and POD Packing Coil)
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We sell our products to hospitals primarily through our direct sales
organization in the United States, most of Europe, Canada and Australia, as well
as through distributors in select international markets. In the six months ended
June 30, 2020 and 2019, 28.3% and 35.7% of our revenue, respectively, was
generated from customers located outside of the United States. Our sales outside
of the United States are denominated principally in the euro and Japanese yen,
with some sales being denominated in other currencies. As a result, we have
foreign exchange exposure but do not currently engage in hedging.
We generated revenue of $242.4 million and $262.6 million for the six months
ended June 30, 2020 and 2019, respectively, a decrease of $20.2 million. We
generated an operating loss of $17.0 million and operating income of $24.0
million for the six months ended June 30, 2020 and 2019, respectively.
COVID-19 Pandemic
In March 2020, the World Health Organization declared the outbreak of COVID-19
as a pandemic, which continues to spread throughout the U.S. and the world. In
response, governments have issued orders restricting certain activities, and
while our business falls within the category of healthcare operations, which are
essential businesses that need to continue during the COVID-19 outbreak, we have
experienced, and expect to continue to experience, disruptions to our operations
as a result of the pandemic. For example, hospital resources have been diverted
to fight the pandemic, and many government agencies in conjunction with
healthcare systems have recommended the deferral of elective and semi-elective
medical procedures during the outbreak. Some of Penumbra's medical devices are
used in certain procedures that the United States Centers for Medicare &
Medicaid Services ("CMS") has indicated are "high-acuity" procedures that should
not be postponed during the outbreak in its March 18, 2020 recommendations,
while other Penumbra devices are used in elective procedures that physicians may
consider postponing. Many of the procedures in which our vascular products are
used are elective in nature, whereas procedures in which our neuro products are
used, such as stroke, tend to be more emergent in nature.
The impact of COVID-19 on our business remains fluid, and we continue to
actively monitor the dynamic situation. We are undertaking the following
specific actions and strategic priorities to navigate the pandemic:
•We have made changes to how we manufacture, inspect and ship our products to
prioritize the health and safety of our employees and to operate under the
protocols mandated by our local and state governments. While we are committed to
continue meeting demand for our essential devices, we have implemented social
distancing and other measures to protect the health and safety of our employees,
which have reduced, and may continue to reduce, our manufacturing capacity.
•In order to strengthen our liquidity position, we issued and sold an aggregate
of 865,963 shares of our common stock at a public offering price of $166.00 per
share, less the underwriters' discounts and commissions, pursuant to an
underwritten public offering in June 2020. We received approximately $134.8
million in net cash proceeds from the offering after deducting underwriting
discounts and commissions of $8.6 million and other offering expenses of $0.4
million.
•We further strengthened our liquidity position by entering into a Credit
Agreement (the "Credit Agreement") on April 24, 2020, with JPMorgan Chase Bank,
N.A., as administrative agent and lender, and Bank of America, N.A. and
Citibank, N.A. as lenders. The Credit Agreement is secured and provides for up
to $100 million in available revolving borrowing capacity with an option,
subject to certain conditions, for us to increase the aggregate borrowing
capacity to up to $150 million, and matures on April 23, 2021. This revolving
line of credit provides access to capital beyond the $278.3 million in cash,
cash equivalents and marketable investments on our balance sheet as of June 30,
2020, and we believe this will allow us to both navigate the current environment
and emerge in a strong position after the pandemic. As of June 30, 2020, there
were no borrowings outstanding under the Credit Agreement.
•We will continue to prioritize investments in our production capacity and
flexibility, commercial channels, preparation for new product launches, and new
product developments to help patients.
While we saw recent positive trends in our business beginning in May and
continuing through June 2020, after experiencing negative impacts on business
trends in April due to the COVID-19 outbreak, the general impact of COVID-19 on
our business has been negative and we are unable to reliably predict the full
impact that COVID-19 will have on our business due to numerous uncertainties,
including the severity and duration of the outbreak, additional actions that may
be taken by governmental authorities in response to the outbreak, the impact of
the outbreak on the business of our customers, distributors and suppliers, other
businesses and worldwide economies in general, our ability to have access to our
customers to provide training and case support, and other factors identified in
Part II, Item 1A "Risk Factors" in this Quarterly Report on Form 10-Q. We will
continue to evaluate the nature and extent of the impact of COVID-19 on our
business, consolidated results of operations, and financial condition.
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Factors Affecting Our Performance
There are a number of factors that have impacted, and we believe will continue
to impact, our results of operations and growth. These factors include:
•The COVID-19 outbreak and measures taken in response thereto, which have
negatively affected, and we expect will continue to negatively affect, our
revenues and results of operations. Due to these impacts and measures, we may
experience significant and unpredictable fluctuations in demand for certain of
our products as hospital customers re-prioritize the treatment of patients and
distributors adjust their operations to support the current demand level.
•The rate at which we grow our salesforce and the speed at which newly hired
salespeople become fully effective can impact our revenue growth or our costs
incurred in anticipation of such growth.
•Our industry is intensely competitive and, in particular, we compete with a
number of large, well-capitalized companies. We must continue to successfully
compete in light of our competitors' existing and future products and their
resources to successfully market to the specialist physicians who use our
products.
•We must continue to successfully introduce new products that gain acceptance
with specialist physicians and successfully transition from existing products to
new products, ensuring adequate supply. In addition, as we introduce new
products and expand our production capacity, we anticipate additional personnel
will be hired and trained to build our inventory of components and finished
goods in advance of sales, which may cause quarterly fluctuations in our
operating results and financial condition.
•Publications of clinical results by us, our competitors and other third parties
can have a significant influence on whether, and the degree to which, our
products are used by specialist physicians and the procedures and treatments
those physicians choose to administer for a given condition.
•The specialist physicians who use our products may not perform procedures
during certain times of the year, such as those periods when they are at major
medical conferences or are away from their practices for other reasons, the
timing of which occurs irregularly during the year and from year to year.
•Most of our sales outside of the United States are denominated in the local
currency of the country in which we sell our products. As a result, our revenue
from international sales can be significantly impacted by fluctuations in
foreign currency exchange rates.
•The availability and levels of reimbursement within the relevant healthcare
payment system for healthcare providers for procedures in which our products are
used.
In addition, we have experienced and expect to continue to experience meaningful
variability in our quarterly revenue, gross profit and gross margin percentage
as a result of a number of factors, including, but not limited to: the impact of
COVID-19, the number of available selling days, which can be impacted by
holidays; the mix of products sold; the geographic mix of where products are
sold; the demand for our products and the products of our competitors; the
timing of or failure to obtain regulatory approvals or clearances for products;
increased competition; the timing of customer orders; inventory write-offs due
to obsolescence; costs, benefits and timing of new product introductions; costs,
benefits and timing of the acquisition and integration of businesses and product
lines we may acquire; the availability and cost of components and raw materials;
and fluctuations in foreign currency exchange rates. We may experience quarters
in which we have significant revenue growth sequentially followed by quarters of
moderate or no revenue growth. Additionally, we may experience quarters in which
operating expenses, in particular research and development expenses, fluctuate
depending on the stage and timing of product development.
Components of Results of Operations
Revenue. We sell our products directly to hospitals and other healthcare
providers and through distributors for use in procedures performed by specialist
physicians to treat patients in two key markets: neuro and vascular disease. We
sell our products through purchase orders, and we do not have long term purchase
commitments from our customers. Revenue from product sales is recognized either
on the date of shipment or the date of receipt by the customer, but is deferred
for certain transactions when control has not yet transferred. With respect to
products that we consign to hospitals, which primarily consist of coils, we
recognize revenue at the time hospitals utilize products in a procedure. Revenue
also includes shipping and handling costs that we charge to customers.
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Cost of Revenue. Cost of revenue consists primarily of the cost of raw materials
and components, personnel costs, including stock-based compensation, inbound
freight charges, receiving costs, inspection and testing costs, warehousing
costs, royalty expense, shipping and handling costs, and other labor and
overhead costs incurred in the manufacturing of products. In addition, we record
write-downs or write-offs of inventory in the event that a portion of our
inventory becomes excess or obsolete.
We manufacture substantially all of our products in our manufacturing facilities
in Alameda and Roseville, California.
Operating Expenses
Research and Development ("R&D"). R&D expenses primarily consist of product
development, clinical and regulatory expenses, materials, depreciation and other
costs associated with the development of our products. R&D expenses also include
salaries, benefits and other related costs, including stock-based compensation,
for personnel and consultants. We generally expense R&D costs as they are
incurred, with the exception of certain costs incurred for the development of
computer software for internal use related to our REAL Immersive System
offerings. We capitalize certain costs when it is determined that it is probable
that the project will be completed and the software will be used to perform the
function intended, and the preliminary project stage is completed. Capitalized
internal use software development costs are included in property and equipment,
net within the condensed consolidated balance sheets.
Sales, General and Administrative ("SG&A"). SG&A expenses primarily consist of
salaries, benefits and other related costs, including stock-based compensation,
for personnel and consultants engaged in sales, marketing, finance, legal,
compliance, administrative, facilities and information technology and human
resource activities. Our SG&A expenses also include marketing trials, medical
education, training, commissions, generally based on sales, to direct sales
representatives, amortization of acquired intangible assets and
acquisition-related costs.
(Benefit from) Provision For Income Taxes
We are taxed at the rates applicable within each jurisdiction in which we
operate. The composite income tax rate, tax provisions, deferred tax assets
("DTAs") and deferred tax liabilities will vary according to the jurisdiction in
which profits arise. Tax laws are complex and subject to different
interpretations by management and the respective governmental taxing
authorities, and require us to exercise judgment in determining our income tax
provision, our deferred tax assets and deferred tax liabilities and the
potential valuation allowance recorded against our net DTAs. Deferred tax assets
and liabilities are determined using the enacted tax rates in effect for the
years in which those tax assets are expected to be realized. A valuation
allowance is established when it is more likely than not that the future
realization of all or some of the DTAs will not be achieved.
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Results of Operations
The following table sets forth the components of our condensed consolidated
statements of operations in dollars and as a percentage of revenue for the
periods presented:
                                                           Three Months Ended June 30,                                                                                               Six Months Ended June 30,
                                                    2020                                                         2019                                                      2020                               2019
                                                      (in thousands, except for percentages)                                                                                   (in thousands, except for percentages)
Revenue                            $        105,109               100.0  %       $ 134,201             100.0  %       $ 242,438             100.0  %       $ 262,640                    100.0  %
Cost of revenue                              40,179                38.2             40,273              30.0             89,499              36.9             84,802                     32.3
Gross profit                                 64,930                61.8             93,928              70.0            152,939              63.1            177,838                     67.7
Operating expenses:
Research and development                     22,725                21.6             13,462              10.0             35,671              14.7             25,129                      9.6
Sales, general and administrative            59,854                56.9             67,665              50.4            134,307              55.4            128,756                     49.0

Total operating expenses                     82,579                78.6             81,127              60.5            169,978              70.1            153,885                     58.6
(Loss) income from operations               (17,649)              (16.8)            12,801               9.5            (17,039)             (7.0)            23,953                      9.1
Interest income, net                            108                 0.1                784               0.6                407               0.2              1,517                      0.6
Other income (expense), net                     511                 0.5                (71)             (0.1)            (1,144)             (0.5)               (47)                       -
(Loss) income before income taxes           (17,030)              (16.2)            13,514              10.1            (17,776)             (7.3)            25,423                      9.7
Benefit from income taxes                    (4,129)               (3.9)            (2,735)             (2.0)            (5,763)             (2.4)            (1,280)                    (0.5)

Consolidated net (loss) income     $        (12,901)              (12.3) %       $  16,249              12.1  %       $ (12,013)             (5.0) %       $  26,703                     10.2  %
Net loss attributable to
non-controlling interest                       (941)               (0.9)              (339)             (0.3)            (1,478)             (0.6)              (583)                    (0.2)
Net (loss) income attributable to
Penumbra, Inc.                     $        (11,960)              (11.4) %       $  16,588              12.4  %       $ (10,535)             (4.3) %       $  27,286                     10.4  %



Three Months Ended June 30, 2020 Compared to the Three Months Ended June 30,
2019
Revenue
                 Three Months Ended June 30,                               Change
                 2020                      2019             $              %
                          (in thousands, except for percentages)
Neuro      $      58,837               $  81,547       $ (22,710)       (27.8) %
Vascular          46,272                  52,654          (6,382)       (12.1) %
Total      $     105,109               $ 134,201       $ (29,092)       (21.7) %


Revenue decreased $29.1 million, or 21.7%, to $105.1 million in the three months
ended June 30, 2020, from $134.2 million in the three months ended June 30,
2019. The overall decrease in our revenue is primarily due to a decline in our
products sales within our neuro and vascular business as a result of the
negative impact of the COVID-19 pandemic.
Revenue from our neuro products decreased $22.7 million, or 27.8%, to $58.8
million in the three months ended June 30, 2020, from $81.5 million in the three
months ended June 30, 2019. This was primarily attributable to decreased sales
of our neuro thrombectomy products and neuro embolization products, which
globally declined by 32.7% and 21.3% in the three months ended June 30, 2020,
respectively. These decreases were primarily due to lower sales volume as a
result of hospitals performing fewer procedures as well as a decline in
international distribution sales, both primarily resulting from the response to
the COVID-19 pandemic. Prices for our neuro products remained substantially
unchanged during the period.
Revenue from our vascular products decreased $6.4 million, or 12.1%, to $46.3
million in the three months ended June 30, 2020, from $52.7 million in the three
months ended June 30, 2019. This decrease was driven by a decline in sales of
our vascular embolization products and vascular thrombectomy products, which
globally declined by 18.9% and 5.0% in the three months ended June 30, 2020,
respectively. Similar to our neuro business, these decreases were primarily due
to lower sales volume as a result of hospitals performing fewer procedures as
well as a decline in international distribution sales, both
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primarily resulting from the response to the COVID-19 pandemic. Prices for our
vascular products remained substantially unchanged during the period.
Although we saw recent positive trends in our business in the US and other parts
of the world beginning in May and continuing through June 2020 after
experiencing negative impacts on business trends in April due to the COVID-19
outbreak, the general impact of COVID-19 on our business has been negative and
we may continue to observe a negative impact on revenue in the third quarter due
to COVID-19, particularly for our international sales, as our distributors try
to navigate the pandemic and its impact on their own businesses. As a
consequence, we cannot reliably estimate the extent to which the COVID-19
pandemic may negatively impact our revenue in the third quarter and beyond.
Revenue by Geographic Area
The following table presents revenue by geographic area, based on our customers'
shipping destinations, for the three months ended June 30, 2020 and 2019:
                                                          Three Months Ended June 30,                                                                              Change
                                                  2020                                                         2019                                      $       %
                                                                       (in thousands, except for percentages)
United States                    $     78,043                    74.2  %       $  86,374               64.4  %       $  (8,331)              (9.6) %

International                          27,066                    25.8  %          47,827               35.6  %         (20,761)             (43.4) %
Total                            $    105,109                   100.0  %       $ 134,201              100.0  %       $ (29,092)             (21.7) %


Revenue from product sales in international markets decreased $20.8 million, or
43.4%, to $27.1 million in the three months ended June 30, 2020, from $47.8
million in the three months ended June 30, 2019. Revenue from international
sales represented 25.8% and 35.6% of our total revenue for the three months
ended June 30, 2020 and 2019, respectively.
Gross Margin
                         Three Months Ended June 30,                               Change
                        2020                       2019             $              %
                                  (in thousands, except for percentages)
Cost of revenue   $      40,179                 $ 40,273       $     (94)        (0.2) %
Gross profit      $      64,930                 $ 93,928       $ (28,998)       (30.9) %
Gross margin %             61.8   %                 70.0  %


Gross margin decreased 8.2 percentage points to 61.8% in the three months ended
June 30, 2020, from 70.0% in the three months ended June 30, 2019. The decrease
in gross margin was primarily driven by a decline in revenue in the second
quarter of 2020, primarily due to the impacts of COVID-19 discussed above, and
by additional period expense incurred as we made the decision to continue to pay
all of our direct manufacturing workforce full-time wages while reducing the
labor capacity per shift to implement social distancing and other protective
measures for the health and safety of our employees. Accordingly, certain labor
costs were expensed as incurred in the three months ended June 30, 2020.
We may observe a decrease in overall demand for our products in the third
quarter of 2020 due to the impact of the COVID-19 pandemic. As a result, our
gross margin will be lower as a function of volume absorption and continued
investments in ramping up our infrastructure. However, we cannot reliably
estimate the extent to which the COVID-19 pandemic will impact our gross margin
in the third quarter and beyond due to numerous uncertainties with respect to
the COVID-19 pandemic and response thereto.
Research and Development ("R&D")
                                        Three Months Ended June 30,                             Change
                                       2020                       2019            $            %
                                               (in thousands, except for percentages)
R&D                              $      22,725                 $ 13,462       $ 9,263        68.8  %
R&D as a percentage of revenue            21.6   %                 10.0  %


R&D expenses increased by $9.3 million, or 68.8%, to $22.7 million in the three
months ended June 30, 2020, from $13.5 million in the three months ended June
30, 2019. The increase was primarily due to a $5.6 million increase in product
development and testing costs.
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We have made investments, and plan to continue to make investments, in the
development of our products, which may include hiring additional research and
development employees. In addition, we have experienced in the past, and may
continue to experience in the future, variability in expenses incurred due to
the timing and costs of clinical trials and product development.
Sales, General and Administrative ("SG&A")
                                                   Three Months Ended June 30,                                     Change
                                                     2020                 2019                $                   %
                                                                  (in thousands, except for percentages)
SG&A                                           $      59,854           $ 67,665          $ (7,811)                 (11.5) %
SG&A as a percentage of revenue                         56.9   %           

50.4 %




SG&A expenses decreased by $7.8 million, or 11.5%, to $59.9 million in the three
months ended June 30, 2020, from $67.7 million in the three months ended June
30, 2019. The decrease was primarily due to a $5.1 million decrease in cost
related to marketing events, a $4.6 million decrease in travel-related expenses,
partially offset by a $1.1 million increase in infrastructure cost, and a $0.9
million increase in personnel-related expense.
Our operating expenses in the second quarter of 2020 reflected reductions in
expenditures from activities restricted by COVID-19, such as travel and
entertainment expenses. We expect additional reductions in expenses related to
the current environment and we have implemented other cost control measures.
While certain spending may continue to decrease in the third quarter of 2020 as
a result of the pandemic and such measures, we expect an increase in
sales-related activities and we will continue to prioritize our investments in
production capacity and flexibility, commercial channels, and preparation for
new product launches to support our customers.
Benefit from Income Taxes
                                   Three Months Ended June 30,                              Change
                                  2020                       2019             $            %
                                           (in thousands, except for percentages)
Benefit from income taxes   $      (4,129)                $ (2,735)      $ (1,394)       51.0  %
Effective tax rate                   24.2   %                (20.2) %


During interim periods, we generally utilize the estimated annual effective tax
rate ("AETR") method which involves the use of forecasted information. However,
for the three months ended June 30, 2020, the estimated AETR method yielded
unconventional results and would not provide a reliable estimate of income
taxes. Therefore, we determined that using the discrete effective tax rate
method, which involves the use of year-to-date information, would provide a more
reliable estimate of income taxes for the current period.
Our benefit from income taxes was $4.1 million for the three months ended June
30, 2020, which was primarily due to tax benefits attributable to our worldwide
losses as a result of the COVID-19 pandemic impact and excess tax benefits from
stock-based compensation attributable to our U.S. jurisdiction. The effective
tax rate was 24.2% for the three months ended June 30, 2020. Our benefit from
income taxes was $2.7 million for the three months ended June 30, 2019, which
was primarily due to excess tax benefits from stock-based compensation
attributable to our U.S. jurisdiction, offset by income taxes attributable to
our worldwide profits. The effective tax rate was (20.2)% for the three months
ended June 30, 2019. Using the discrete method instead of the AETR method to
compute income taxes for the three months ended June 30, 2020 achieved a more
reasonable comparison of the effective tax rates when compared to the three
months ended June 30, 2019. Our change in effective tax rate was primarily
attributable to larger tax benefits over worldwide losses for the three months
ended June 30, 2020, when compared to smaller tax benefits over worldwide
profits for the three months ended June 30, 2019.
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Six Months Ended June 30, 2020 Compared to the Six Months Ended June 30, 2019
Revenue
                 Six Months Ended June 30,                              Change
                 2020                   2019             $              %
                         (in thousands, except for percentages)
Neuro      $    136,913             $ 163,018       $ (26,105)       (16.0) %
Vascular        105,525                99,622           5,903          5.9  %
Total      $    242,438             $ 262,640       $ (20,202)        (7.7) %


Revenue decreased $20.2 million, or 7.7%, to $242.4 million in the six months
ended June 30, 2020, from $262.6 million in the six months ended June 30, 2019.
The decline in sales of products within our neuro business drove the overall
change in revenue, which was partially offset by sales of new and existing
products within our vascular business.
Revenue from our neuro products decreased $26.1 million, or 16.0%, to $136.9
million in the six months ended June 30, 2020, from $163.0 million in the six
months ended June 30, 2019. This was primarily attributable to decreased sales
of our neuro thrombectomy products and neuro embolization products, which
globally declined by 20.7% and 13.2% in the six months ended June 30, 2020,
respectively. This decrease was primarily attributable to decreased sales in
Japan as a result of reimbursement changes and on-going discussions with our
distributor partner, as well as to lower sales volume as a result of hospitals
performing fewer procedures as well as a decline in international distribution
sales, both primarily as well as a decline in international distribution sales,
both primarily resulting from the response to the COVID-19 pandemic. Prices for
our neuro products remained substantially unchanged during the period.
Revenue from our vascular products increased $5.9 million, or 5.9%, to $105.5
million in the six months ended June 30, 2020, from $99.6 million in the six
months ended June 30, 2019. This increase was driven by sales of our vascular
thrombectomy products, which globally increased by 11.4% in the six months ended
June 30, 2020. This increase was primarily due to higher sales volume as a
result of hospitals performing more procedures using our products prior to the
COVID-19 pandemic, partially offset by hospitals performing fewer procedures as
well as a decline in international distribution sales, both primarily resulting
from the response to the COVID-19 pandemic. Prices for our vascular products
remained substantially unchanged during the period.
Revenue by Geographic Area
The following table presents revenue by geographic area, based on our customer's
shipping destination, for the six months ended June 30, 2020 and 2019:
                                                         Six Months Ended June 30,                                                                              Change
                                                 2020                                                       2019                                      $       %
                                                                      (in thousands, except for percentages)
United States                    $      173,817               71.7  %       $ 168,885               64.3  %       $   4,932                2.9  %

Other International                      68,621               28.3  %          93,755               35.7  %         (25,134)             (26.8) %
Total                            $      242,438              100.0  %       $ 262,640              100.0  %       $ (20,202)              (7.7) %


Revenue from sales in international markets decreased $25.1 million, or 26.8%,
to $68.6 million in the six months ended June 30, 2020, from $93.8 million in
the six months ended June 30, 2019. Revenue from international sales represented
28.3% and 35.7% of our total revenue for the six months ended June 30, 2020 and
2019, respectively.
Gross Margin
                        Six Months Ended June 30,                              Change
                        2020                   2019             $              %
                                (in thousands, except for percentages)
Cost of revenue   $     89,499             $  84,802       $   4,697          5.5  %
Gross profit      $    152,939             $ 177,838       $ (24,899)       (14.0) %
Gross margin %            63.1   %              67.7  %


Gross margin decreased 4.6 percentage points to 63.1% in the six months ended
June 30, 2020, from 67.7% in the six months ended June 30, 2019. The decrease in
gross margin was primarily driven by a decline in revenue in the six months
ended June 30, 2020, primarily due to the impacts of COVID-19 discussed above,
and by additional period expense incurred as
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we made the decision to continue to pay all of our direct manufacturing
workforce full-time wages while reducing the labor capacity per shift to
implement social distancing and other protective measures for the health and
safety of our employees. Accordingly, certain labor costs were expensed as
incurred in the six months ended June 30, 2020.
We may observe a decrease in overall demand for our products in the third
quarter of 2020 due to the impact of the COVID-19 pandemic. As a result, our
gross margin will be lower as a function of volume absorption and continued
investments in ramping up our infrastructure. However, we cannot reliably
estimate the extent to which the COVID-19 pandemic will impact our gross margin
in the third quarter and beyond due to numerous uncertainties with respect to
the COVID-19 pandemic and response thereto.
Research and Development ("R&D")
                                       Six Months Ended June 30,                              Change
                                       2020                    2019             $            %
                                              (in thousands, except for percentages)
R&D                              $     35,671               $ 25,129       $ 10,542        42.0  %
R&D as a percentage of revenue           14.7   %                9.6  %


R&D expenses increased by $10.5 million, or 42.0%, to $35.7 million in the six
months ended June 30, 2020, from $25.1 million in the six months ended June 30,
2019. The increase was primarily due to a $4.9 million increase in product
development and testing costs, and a $2.7 million increase in personnel-related
expenses primarily due to an increase in headcount to support our growth.
We have made investments, and plan to continue to make investments, in the
development of our products, which may include hiring additional research and
development employees. In addition, we have experienced in the past, and may
continue to experience in the future, variability in expenses incurred due to
the timing and costs of clinical trials and product development.
Sales, General and Administrative (SG&A)
                                        Six Months Ended June 30,                            Change
                                        2020                   2019            $            %
                                              (in thousands, except for percentages)
SG&A                              $    134,307             $ 128,756       $ 5,551         4.3  %
SG&A as a percentage of revenue           55.4   %              49.0  %


SG&A expenses increased by $5.6 million, or 4.3%, to $134.3 million in the six
months ended June 30, 2020, from $128.8 million in the six months ended June 30,
2019. The increase was primarily due to a $9.3 million increase in
personnel-related expense, a $2.9 million increase in infrastructure costs,
partially offset by a $4.4 million decrease in cost related to marketing events,
and a $4.4 million decrease in travel-related expenses.
Our operating expenses in the six months ended June 30, 2020 reflected
reductions in expenditures from activities restricted by COVID-19, such as
travel and entertainment expenses. We expect additional reductions in expenses
related to the current environment and we have implemented other cost control
measures. While certain spending may continue to decrease in the third quarter
of 2020 as a result of the pandemic and such measures, we expect an increase in
sales-related activities and we will continue to prioritize our investments in
production capacity and flexibility, commercial channels, and preparation for
new product launches to support our customers.
Benefit from Income Taxes
                                  Six Months Ended June 30,                              Change
                                  2020                    2019             $             %
                                          (in thousands, except for percentages)
Benefit from income taxes   $     (5,763)              $ (1,280)      $ (4,483)       350.2  %
Effective tax rate                  32.4   %               (5.0) %


During interim periods, we generally utilize the estimated annual effective tax
rate ("AETR") method which involves the use of forecasted information. However,
for the six months ended June 30, 2020, the estimated AETR method yielded
unconventional results and would not provide a reliable estimate of income
taxes. Therefore, we determined that using the discrete effective tax rate
method, which involves the use of year-to-date information, would provide a more
reliable estimate of income taxes for the current period.
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Our benefit from income taxes was $5.8 million for the six months ended June 30,
2020, which was primarily due to tax benefits attributable to our worldwide
losses as a result of the COVID-19 pandemic impact and excess tax benefits from
stock-based compensation attributable to our U.S. jurisdiction. The effective
tax rate was 32.4% for the six months ended June 30, 2020. Our benefit from
income taxes was $1.3 million for the six months ended June 30, 2019, which was
primarily due to excess tax benefits from stock-based compensation attributable
to our U.S. jurisdiction, offset by income taxes attributable to our worldwide
profits. The effective tax rate was (5.0)% for the six months ended June 30,
2019. Using the discrete method instead of the AETR method to compute income
taxes for the six months ended June 30, 2020 achieved a more reasonable
comparison of the effective tax rates when compared to the six months ended June
30, 2019. Our change in effective tax rate was primarily attributable to larger
tax benefits over worldwide losses for the six months ended June 30, 2020, when
compared to smaller tax benefits over worldwide profits for the six months ended
June 30, 2019.
Prospectively, our effective tax rate will likely be driven by (1) permanent
differences in taxable income for tax and financial reporting purposes, (2) tax
expense attributable to our worldwide profits, and (3) discrete tax adjustments
such as excess tax benefits related to stock-based compensation. Our income tax
provision is subject to volatility as the amount of excess tax benefits can
fluctuate from period to period based on the price of our stock, the volume of
share-based grants settled or vested, and the fair value assigned to equity
awards under U.S. GAAP. In addition, changes in tax law or our interpretation
thereof, and changes to our valuation allowance could result with fluctuations
in our effective tax rate.
Liquidity and Capital Resources
As of June 30, 2020, we had $498.3 million in working capital, which included
$134.4 million in cash and cash equivalents and $143.9 million in marketable
investments. As of June 30, 2020, we held approximately 11.0% of our cash and
cash equivalents in foreign entities.
In June 2020, we issued and sold an aggregate of 865,963 shares of our common
stock at a public offering price of $166.00 per share, less the underwriters'
discounts and commissions, pursuant to an underwritten public offering. We
received approximately $134.8 million in net cash proceeds from the offering
after deducting underwriting discounts and commissions of $8.6 million and other
offering expenses of $0.4 million. We intend to use the net proceeds from the
offering for general corporate purposes, including working capital, continued
development of our products, including research and development and clinical
trials, potential acquisitions and other business opportunities. Pending the use
of the net proceeds from the offering, we are investing the net proceeds in
investment grade, interest bearing securities.
In addition to our existing cash and cash equivalents and marketable investment
balances, our principal source of liquidity is our accounts receivable. In order
to further strengthen our liquidity position and financial flexibility during
the COVID-19 pandemic, on April 24, 2020 we entered into a Credit Agreement (the
"Credit Agreement") with JPMorgan Chase Bank, N.A., as administrative agent and
lender, and Bank of America, N.A. and Citibank, N.A. as lenders. The Credit
Agreement is secured and provides for up to $100 million in available revolving
borrowing capacity with an option, subject to certain conditions, for the
Company to increase the aggregate borrowing capacity to up to $150 million, and
matures on April 23, 2021. See Note "8. Indebtedness" to our condensed
consolidated financial statements in Part I, Item 1 of this Quarterly Report on
Form 10-Q for more information.
We believe our sources of liquidity will be sufficient to meet our liquidity
requirements for at least the next 12 months. Our principal liquidity
requirements are to fund our operations, expand manufacturing operations which
includes, but is not limited to, maintaining sufficient levels of inventory to
meet the anticipated demand of our customers, fund research and development
activities and fund our capital expenditures. We may also lease or purchase
additional facilities to facilitate our growth. We expect to continue to make
investments as we launch new products, expand our manufacturing operations and
IT infrastructures and further expand into international markets. We may,
however, require or elect to secure additional financing as we continue to
execute our business strategy. If we require or elect to raise additional funds,
we may do so through equity or debt financing, which may not be available on
favorable terms, could result in dilution to our stockholders, could result in
changes to our capital structure, and could require us to agree to covenants
that limit our operating flexibility.
As a result of the COVID-19 pandemic, we may experience reduced cash flow from
operations in the third quarter of 2020 as a result of decreased revenues and
potentially slower accounts receivable collections. Moreover, we are focused on
ensuring that we have adequate supplies on hand given the potential disruption
of the COVID-19 pandemic to our suppliers and their supply chain and,
accordingly, we expect to continue to increase inventory during the third
quarter of 2020 and beyond. However, we cannot reliably estimate the extent to
which the COVID-19 pandemic will impact our cash flow from operations in the
third quarter and beyond.
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The following table summarizes our cash and cash equivalents, marketable
investments and selected working capital data as of June 30, 2020 and December
31, 2019:
                             June 30, 2020       December 31, 2019
                                        (in thousands)
Cash and cash equivalents   $     134,381       $         72,779
Marketable investments            143,914                116,610
Accounts receivable, net           97,613                105,901
Accounts payable                   14,432                 15,111
Accrued liabilities                57,718                 67,630
Working capital(1)                498,283                372,086


__________________
(1)Working capital consists of total current assets less total current
liabilities.
The following table sets forth, for the periods indicated, our beginning balance
of cash and cash equivalents, net cash flows provided by (used in) operating,
investing and financing activities and our ending balance of cash and cash
equivalents:
                                                                            Six Months Ended June 30,
                                                                             2020                 2019
                                                                                 (in thousands)
Cash and cash equivalents and restricted cash at beginning of period   $     72,779           $  67,850
Net cash used in operating activities                                       (27,609)               (165)
Net cash (used in) provided by investing activities                         (44,507)             16,742
Net cash provided by (used in) financing activities                         134,111              (7,018)
Cash and cash equivalents and restricted cash at end of period              134,381              77,261


Net Cash Used In Operating Activities
Net cash used in operating activities consists primarily of consolidated net
income adjusted for certain non-cash items (including depreciation and
amortization, stock-based compensation expense, inventory write-downs, and
changes in deferred tax balances), and the effect of changes in working capital
and other activities.
Net cash used in operating activities was $27.6 million during the six months
ended June 30, 2020 and consisted of consolidated net loss of $12.0 million and
net changes in operating assets and liabilities of $34.5 million, offset by
non-cash items of $18.9 million. The change in operating assets and liabilities
includes an increase in inventories of $31.9 million, and an increase in prepaid
expenses and other current and non-current assets of $4.3 million. This was
partially offset by an decrease in accounts receivable of $6.8 million and other
non-current liabilities of $5.1 million.
Net cash used in operating activities was $0.2 million during the six months
ended June 30, 2019 and consisted of a consolidated net income of $26.7 million
and non-cash items of $14.5 million, offset by net changes in operating assets
and liabilities of $41.4 million. The change in operating assets and liabilities
includes an increase in inventories of $18.5 million to support our revenue
growth, an increase in accounts receivable of $17.6 million, an increase in
prepaid expenses and other current and non-current assets of $3.8 million and a
decrease in accrued expenses and other non-current liabilities of $1.9 million,
partially offset by an increase in accounts payable of $0.4 million as a result
of growth in our business activities.
Net Cash (Used In) Provided By Investing Activities
Net cash (used in) provided by investing activities relates primarily to
purchases of marketable investments, net of proceeds from maturities and sales
and by capital expenditures.
Net cash used in investing activities was $44.5 million during the six months
ended June 30, 2020 and consisted of purchases of marketable investments, net of
proceeds from maturities and sales, of $25.6 million, and capital expenditures
of $16.9 million.
Net cash provided by investing activities was $16.7 million during the six
months ended June 30, 2019 and consisted of proceeds from maturities and sales
of marketable investments, net of purchases, of $24.0 million, partially offset
by capital expenditures of $6.2 million.
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Net Cash Provided By (Used In) Financing Activities
Net cash provided by (used in) financing activities primarily relates to
payments of employee taxes related to vested restricted stock units, payments
towards the reduction of our finance lease obligations and certain
acquisition-related payments, and proceeds from exercises of stock options and
issuance of common stock.
Net cash provided by financing activities was $134.1 million during the six
months ended June 30, 2020 and primarily consisted of proceeds from the issuance
of common stock net of issuance cost of $134.8 million, proceeds from the
issuance of common stock under our employee stock purchase plan of $5.9 million,
and proceeds from exercises of stock options of $1.2 million. This was partially
offset by $3.9 million of payments of employee taxes related to vested
restricted stock and restricted stock units, $3.0 million in payments towards
finance leases, and $0.7 million related to contingent consideration payments
made in the first quarter of 2020 in connection with our acquisition of Crossmed
S.p.a. in 2017.
Net cash used in financing activities was $7.0 million during the six months
ended June 30, 2019 and primarily consisted of $13.4 million of payments of
employee taxes related to vested restricted stock and restricted stock units and
$1.2 million primarily related to contingent consideration payments made in the
first quarter of 2019 in connection with our acquisition of Crossmed S.p.a. in
2017. This was partially offset by proceeds from the issuance of common stock
under our employee stock purchase plan of $4.8 million and proceeds from stock
option exercises of $2.3 million.
Contractual Obligations and Commitments
There have been no material changes to our contractual obligations and
commitments as of June 30, 2020 from those disclosed in our Annual Report on
Form 10-K for the year ended December 31, 2019.
Off-Balance Sheet Arrangements
We do not have any significant off-balance sheet arrangements or holdings in
variable interest entities.
Critical Accounting Policies and Estimates
We have prepared our financial statements in accordance with U.S. GAAP. Our
preparation of these financial statements requires us to make estimates,
assumptions, and judgments that affect the reported amounts of assets,
liabilities, expenses, and related disclosures at the date of the financial
statements, as well as revenue and expenses recorded during the reporting
periods. We evaluate our estimates and judgments on an ongoing basis. We base
our estimates on historical experience and on various other factors that we
believe are reasonable under the circumstances, the results of which form the
basis for making judgments about the carrying value of assets and liabilities
that are not readily apparent from other sources. Actual results could therefore
differ materially from these estimates under different assumptions or
conditions.
There have been no material changes to our critical accounting policies from
those described in "Management's Discussion and Analysis of Financial Condition
and Results of Operations" included in our Annual Report on Form 10-K for the
year ended December 31, 2019.
Recently Issued Accounting Standards
For information with respect to recently issued accounting standards and the
impact of these standards on our condensed consolidated financial statements,
see Note "2. Summary of Significant Accounting Policies" to our condensed
consolidated financial statements in Part I, Item 1 of this Quarterly Report on
Form 10-Q.
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