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,
2020, included in our Annual Report on Form 10-K filed with the Securities and
Exchange Commission ("SEC") on February 23, 2021.
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, but these words are not the exclusive means for identifying such
statements. 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, 2020. 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
•Virtual Reality Platform - 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 and
Lightning, our next-generation aspiration system for peripheral thrombectomy
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•Peripheral embolization - RUBY Coil System, LANTERN Delivery Microcatheter and
the POD System (POD and POD Packing Coil)
We sell our products to hospitals and other healthcare providers 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, 2021 and 2020, 29.7% and 28.3% 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 $353.5 million and $242.4 million for the six months
ended June 30, 2021 and 2020, respectively, an increase of $111.0 million. We
generated an operating income of $23.8 million and operating loss of $17.0
million for the six months ended June 30, 2021 and 2020, 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 permitted to continue operating during the COVID-19
pandemic, 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 pandemic. 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 pandemic 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 will continue to undertake 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.
•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. This revolving line of credit provides access to
capital beyond the $239.0 million in cash, cash equivalents and marketable
investments on our balance sheet as of June 30, 2021, and we believe this will
allow us to both navigate the current environment and emerge in a strong
liquidity position after the pandemic. During the three months ended March 31,
2021, we entered into an amended one-year 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 amended Credit Agreement extended the maturity
date from April 23, 2021 to February 21, 2022 and has substantially the same
terms and conditions as the prior credit agreement with certain changes
including the exclusion of certain one-time charges and expenses incurred during
the fiscal quarters ended September 30, 2020 and December 31, 2020 from the
calculation of the financial covenants, reductions in interest rate floors
applicable to revolving loans and other changes to borrowing mechanics under the
Credit Agreement. As of June 30, 2021, the Company was in compliance with the
requirements in the amended Credit Agreement. As of June 30, 2021, 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 have seen positive trends in certain areas of our business beginning in
May 2020, we remain mindful of the negative impacts on business trends we
experienced in April 2020 due to the COVID-19 pandemic. The general impact of
COVID-19 on our business has been negative and we are unable to reliably predict
the full impact that the COVID-19 pandemic will have on our business due to
numerous uncertainties, including the severity and duration of the pandemic, the
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global resurgences of cases, particularly as new variants of the virus spread,
additional actions that may be taken by governmental authorities in response to
the pandemic, the impact of the pandemic 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 I, Item 1A "Risk Factors" in our
Annual Report on Form 10-K for the year ended December 31, 2020. 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.
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 pandemic 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. Due to the impact of
the COVID-19 pandemic on our business during the quarter ended June 30, 2020,
comparisons of our results of operations for the three and six months ended June
30, 2021 to the comparable period of the prior year may not be indicative of our
performance in future periods as we saw an increase in elective procedures
during the six months ended June 30, 2021 as COVID-19 vaccinations increased in
the U.S.
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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.
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,
                                               2021                                  2020                                  2021                                  2020
                                                (in thousands, except for percentages)                                      (in thousands, except for percentages)
Revenue                          $   184,258             100.0  %       $ 105,109             100.0  %       $   353,462             100.0  %       $ 242,438             100.0  %
Cost of revenue                       65,572              35.6             40,179              38.2              123,439              34.9             89,499              36.9
Gross profit                         118,686              64.4             64,930              61.8              230,023              65.1            152,939              63.1
Operating expenses:
Research and development              17,738               9.6             22,725              21.6               35,814              10.1             35,671              14.7
Sales, general and
administrative                        90,636              49.2             59,854              56.9              170,434              48.2            134,307              55.4

Total operating expenses             108,374              58.8             82,579              78.6              206,248              58.4            169,978              70.1
Income (loss) from operations         10,312               5.6            (17,649)            (16.8)              23,775               6.7            (17,039)             (7.0)
Interest income, net                     299               0.2                108               0.1                  779               0.2                407               0.2
Other (expense) income, net             (408)             (0.2)               511               0.5               (1,884)             (0.5)            (1,144)             (0.5)
Income (loss) before income
taxes                                 10,203               5.5            (17,030)            (16.2)              22,670               6.4            (17,776)             (7.3)
Provision for (benefit from)
income taxes                           1,904               1.0             (4,129)             (3.9)               3,445               1.0             (5,763)             (2.4)

Consolidated net income (loss)   $     8,299               4.5  %       $ (12,901)            (12.3) %       $    19,225               5.4  %       $ (12,013)             (5.0) %
Net loss attributable to
non-controlling interest                (932)             (0.5)              (941)             (0.9)              (1,842)             (0.5)            (1,478)             (0.6)
Net income (loss) attributable
to Penumbra, Inc.                $     9,231               5.0  %       $ (11,960)            (11.4) %       $    21,067               6.0  %       $ (10,535)             (4.3) %



Three Months Ended June 30, 2021 Compared to the Three Months Ended June 30,
2020
Revenue
                 Three Months Ended June 30,                   Change
                     2021                  2020            $             %
                         (in thousands, except for percentages)
Vascular   $      100,684               $  46,272      $ 54,412       117.6  %
Neuro              83,574                  58,837        24,737        42.0  %
Total      $      184,258               $ 105,109      $ 79,149        75.3  %


Revenue increased $79.1 million, or 75.3%, to $184.3 million in the three months
ended June 30, 2021, from $105.1 million in the three months ended June 30,
2020. Overall revenue growth is primarily due to an increase in sales of new and
existing products within our vascular and neuro businesses, as well as a higher
number of elective procedures performed as COVID-19 vaccination rates increased.
Given the current state of vaccinations and the spread of new variants of the
virus, it is possible that the increase in elective cases will begin to
normalize in future quarters.
Revenue from our vascular products increased $54.4 million, or 117.6%, to $100.7
million in the three months ended June 30, 2021, from $46.3 million in the three
months ended June 30, 2020. This increase was driven by sales of our vascular
thrombectomy products and peripheral embolization products, which globally
increased by 144.2% and 87.4%, respectively in the three months ended June 30,
2021. These increases were primarily due to higher sales volume as a result of
sales of new products, further market penetration of our existing products, and
an increase in the number of elective procedures performed. Prices for our
vascular products remained substantially unchanged during the period.
Revenue from our neuro products increased $24.7 million, or 42.0%, to $83.6
million in the three months ended June 30, 2021, from $58.8 million in the three
months ended June 30, 2020. This increase in revenue from our neuro products was
primarily attributable to increased revenue in China, sales of new products, and
further market penetration of our existing
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products. These increases were driven by an increase in sales of our neuro
access products, neuro embolization products and neuro thrombectomy products
which globally increased by 80.7%, 51.7% and 26.2%, respectively, in the three
months ended June 30, 2021. Prices for our neuro products remained substantially
unchanged during the period.
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, 2021 and 2020:
                                     Three Months Ended June 30,                              Change
                                  2021                              2020                  $             %
                                             (in thousands, except for percentages)
United States      $     128,402               69.7  %    $  78,043        74.2  %    $ 50,359        64.5  %

International             55,856               30.3  %       27,066        25.8  %      28,790       106.4  %
Total              $     184,258              100.0  %    $ 105,109       100.0  %    $ 79,149        75.3  %


Revenue from product sales in international markets increased $28.8 million, or
106.4%, to $55.9 million in the three months ended June 30, 2021, from $27.1
million in the three months ended June 30, 2020. Revenue from international
sales represented 30.3% and 25.8% of our total revenue for the three months
ended June 30, 2021 and 2020, respectively.
Gross Margin
                         Three Months Ended June 30,                   Change
                         2021                      2020            $             %
                                 (in thousands, except for percentages)
Cost of revenue   $       65,572                $ 40,179       $ 25,393        63.2  %
Gross profit      $      118,686                $ 64,930       $ 53,756        82.8  %
Gross margin %              64.4   %                61.8  %


Gross margin increased 2.6 percentage points to 64.4% in the three months ended
June 30, 2021, from 61.8% in the three months ended June 30, 2020. Gross margin
is impacted by our ability to scale production capacity to support our expanding
portfolio of products as well as our continued investments in COVID-19 related
safety measures.
Research and Development ("R&D")
                                        Three Months Ended June 30,                   Change
                                       2021                       2020            $             %
                                                (in thousands, except for percentages)
R&D                              $      17,738                 $ 22,725       $ (4,987)      (21.9) %
R&D as a percentage of revenue             9.6   %                 21.6  %


R&D expenses decreased by $5.0 million, or 21.9%, to $17.7 million in the three
months ended June 30, 2021, from $22.7 million in the three months ended June
30, 2020. The decrease was primarily due to a $5.1 million decrease in product
development and testing costs, partially offset by a $2.3 million increase in
personnel-related expenses driven by 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, which may
include additional personnel-related expenses in conjunction with the launch of
new products.
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Sales, General and Administrative ("SG&A")


                                         Three Months Ended June 30,                   Change
                                        2021                       2020            $             %
                                                 (in thousands, except for percentages)
SG&A                              $      90,636                 $ 59,854       $ 30,782        51.4  %
SG&A as a percentage of revenue            49.2   %                 56.9  %


SG&A expenses increased by $30.8 million, or 51.4%, to $90.6 million in the
three months ended June 30, 2021, from $59.9 million in the three months ended
June 30, 2020. The increase was primarily due to a $20.2 million increase in
personnel-related expenses driven by an increase in headcount and related
expenses to support our growth, a $4.2 million increase in cost related to
marketing events, and a $3.6 million increase in travel-related expenses as most
domestic travel and other in-person activities returned to pre-COVID-19 levels
in the current period.
As we continue to invest in our growth, we have expanded and may continue to
expand our sales, marketing, and general and administrative teams through the
hiring of additional 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 investments in infrastructure to support the
business.
Provision for/(Benefit from) from Income Taxes
                                                 Three Months Ended June 30,                         Change
                                                   2021                 2020                $                    %
                                                                (in thousands, except for percentages)
Provision for (benefit from) income taxes    $      1,904           $  (4,129)         $   6,033                (146.1) %
Effective tax rate                                   18.7   %            24.2  %


Our provision for income taxes was $1.9 million for the three months ended June
30, 2021, which was primarily due to tax expenses attributable to our worldwide
profits, offset by excess tax benefits from stock-based compensation
attributable to our U.S. jurisdiction. 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, combined with excess tax benefits from stock-based compensation
attributable to our U.S. jurisdiction. The effective tax rate was 18.7% for the
three months ended June 30, 2021, compared to 24.2% for the three months ended
June 30, 2020. Our change in effective tax rate was primarily attributable to
small tax expenses over relatively large worldwide profits for the three months
ended June 30, 2021, when compared to large tax benefits over relatively small
worldwide losses for the three months ended June 30, 2020.

Six Months Ended June 30, 2021 Compared to the Six Months Ended June 30, 2020
Revenue
                 Six Months Ended June 30,                    Change
                    2021                 2020             $             %
                         (in thousands, except for percentages)
Vascular   $      189,849             $ 105,525      $  84,324        79.9  %
Neuro             163,613               136,913         26,700        19.5  %
Total      $      353,462             $ 242,438      $ 111,024        45.8  %


Revenue increased $111.0 million, or 45.8%, to $353.5 million in the six months
ended June 30, 2021, from $242.4 million in the six months ended June 30, 2020.
Overall revenue growth is primarily due to an increase in sales of new and
existing products within our vascular and neuro businesses, as well as a higher
number of elective procedures performed as COVID-19 vaccination rates increased.
Given the current state of vaccinations and the spread of new variants of the
virus, it is possible that the increase in elective cases will begin to
normalize in future quarters.
Revenue from our vascular products increased $84.3 million, or 79.9%, to $189.8
million in the six months ended June 30, 2021, from $105.5 million in the six
months ended June 30, 2020. This increase was driven by sales of our vascular
thrombectomy products and peripheral embolization products, which globally
increased by 107.8% and 49.3%, respectively, in the six months ended June 30,
2021. These increases were primarily due to higher sales volume as a result of
sales of new products, further market penetration of our existing products, and
an increase in the number of elective procedures performed. Prices for our
vascular products remained substantially unchanged during the period.
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Revenue from our neuro products increased $26.7 million, or 19.5%, to $163.6
million in the six months ended June 30, 2021, from $136.9 million in the six
months ended June 30, 2020. This increase in revenue from our neuro products was
primarily attributable to increased revenue in China, sales of new products, and
further market penetration of our existing products. This increase was driven by
an increase in sales of our neuro access products, neuro embolization products
and neuro thrombectomy products which globally increased by 62.7%, 18.2% and
4.0%, respectively, in the six months ended June 30, 2021. Prices for our neuro
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, 2021 and 2020:
                                    Six Months Ended June 30,                               Change
                                 2021                            2020                   $             %
                                            (in thousands, except for percentages)
United States      $    248,472             70.3  %    $ 173,817        71.7  %    $  74,655        43.0  %

International           104,990             29.7  %       68,621        28.3  %       36,369        53.0  %
Total              $    353,462            100.0  %    $ 242,438       100.0  %    $ 111,024        45.8  %


Revenue from sales in international markets increased $36.4 million, or 53.0%,
to $105.0 million in the six months ended June 30, 2021, from $68.6 million in
the six months ended June 30, 2020. Revenue from international sales represented
29.7% and 28.3% of our total revenue for the six months ended June 30, 2021 and
2020, respectively.
Gross Margin
                        Six Months Ended June 30,                  Change
                        2021                   2020            $             %
                               (in thousands, except for percentages)
Cost of revenue   $    123,439             $  89,499       $ 33,940        37.9  %
Gross profit      $    230,023             $ 152,939       $ 77,084        50.4  %
Gross margin %            65.1   %              63.1  %


Gross margin increased 2.0 percentage points to 65.1% in the six months ended
June 30, 2021, from 63.1% in the six months ended June 30, 2020. Gross margin is
impacted by our ability to scale production capacity to support our expanding
portfolio of products as well as our continued investments in COVID-19 related
safety measures.
Research and Development ("R&D")
                                        Six Months Ended June 30,                  Change
                                        2021                     2020           $          %
                                             (in thousands, except for percentages)
R&D                              $       35,814               $ 35,671       $ 143       0.4  %
R&D as a percentage of revenue             10.1   %               14.7  %


R&D expenses increased by $0.1 million, or 0.4%, to $35.8 million in the six
months ended June 30, 2021, from $35.7 million in the six months ended June 30,
2020. The increase was primarily due to a $4.0 million increase in
personnel-related expenses, partially offset by a $4.0 million decrease in
product development and testing costs.
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, which may
include additional personnel-related expenses in conjunction with the launch of
new products.
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Sales, General and Administrative (SG&A)


                                        Six Months Ended June 30,                  Change
                                        2021                   2020            $             %
                                               (in thousands, except for percentages)
SG&A                              $    170,434             $ 134,307       $ 36,127        26.9  %
SG&A as a percentage of revenue           48.2   %              55.4  %


SG&A expenses increased by $36.1 million, or 26.9%, to $170.4 million in the six
months ended June 30, 2021, from $134.3 million in the six months ended June 30,
2020. The increase was primarily due to a $29.3 million increase in
personnel-related expense driven by an increase in headcount and related
expenses to support our growth, a $2.3 million increase in travel-related
expenses, and a $1.7 million increase in cost related to marketing events as
most domestic travel and other in-person activities returned to pre-COVID-19
levels in the current period.
As we continue to invest in our growth, we have expanded and may continue to
expand our sales, marketing, and general and administrative teams through the
hiring of additional 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 investments in infrastructure to support the
business.
Provision For (Benefit from) Income Taxes
                                                 Six Months Ended June 30,                          Change
                                                  2021                 2020                $                    %
                                                               (in thousands, except for percentages)
Provision for (benefit from) income taxes    $     3,445           $  (5,763)         $   9,208                (159.8) %
Effective tax rate                                  15.2   %            32.4  %


Our provision for income taxes was $3.4 million for the six months ended June
30, 2021, which was primarily due to tax expenses attributable to our worldwide
profits, offset by excess tax benefits from stock-based compensation
attributable to our U.S. jurisdiction. 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, combined with excess tax benefits from stock-based compensation
attributable to our U.S. jurisdiction. The effective tax rate was 15.2% for the
six months ended June 30, 2021, compared to 32.4% for the six months ended June
30, 2020. Our change in effective tax rate was primarily attributable to small
tax expenses over relatively large worldwide profits for the six months ended
June 30, 2021, when compared to large tax benefits over relatively small
worldwide losses for the six months ended June 30, 2020.
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 profit or tax benefit attributable to our
worldwide losses, 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, 2021, we had $545.1 million in working capital, which included
$82.3 million in cash and cash equivalents and $156.7 million in marketable
investments. As of June 30, 2021, we held approximately 18.8% 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.
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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 us to
increase the aggregate borrowing capacity to up to $150 million, and was set to
mature on April 23, 2021. During the three months ended March 31, 2021, we
entered into an amended one-year 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 amended Credit Agreement extended the maturity
date from April 23, 2021 to February 21, 2022 and has substantially the same
terms and conditions as the prior credit agreement with certain changes
including the exclusion of certain one-time charges and expenses incurred during
the fiscal quarters ended September 30, 2020 and December 31, 2020 from the
calculation of the financial covenants, reductions in interest rate floors
applicable to revolving loans and other changes to borrowing mechanics under the
Credit Agreement. See Note "7. 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
information technology 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.
While we have strengthened our liquidity position, we cannot reliably estimate
the extent to which the COVID-19 pandemic may impact our cash flow from
operations in the third quarter and beyond.
The following table summarizes our cash and cash equivalents, marketable
investments and selected working capital data as of June 30, 2021 and December
31, 2020:
                             June 30, 2021       December 31, 2020
                                         (in thousands)
Cash and cash equivalents   $       82,277      $           69,670
Marketable investments             156,722                 195,162
Accounts receivable, net           136,610                 114,608
Accounts payable                    13,712                  14,109
Accrued liabilities                 86,503                  85,795
Working capital(1)                 545,066                 511,770



(1)Working capital consists of total current assets less total current liabilities.


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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,
                                                                       2021                  2020
                                                                           

(in thousands) Cash and cash equivalents and restricted cash at beginning of period

$      69,670          $    72,779
Net cash used in operating activities                                  (17,678)             (27,609)
Net cash provided by (used in) investing activities                     29,435              (44,507)
Net cash provided by financing activities                                  559              134,111

Cash and cash equivalents and restricted cash at end of period 82,277

              134,381


Net Cash Used In Operating Activities
Net cash used in operating activities consists primarily of consolidated net
income (loss) adjusted for certain non-cash items (including depreciation and
amortization, stock-based compensation expense, inventory write-downs,
impairment of intangible assets, and changes in deferred tax balances), and the
effect of changes in working capital and other activities.
Net cash used in operating activities was $17.7 million during the six months
ended June 30, 2021 and consisted of consolidated net income of $19.2 million
and non-cash items of $29.1 million, offset by net changes in operating assets
and liabilities of $66.0 million. The change in operating assets and liabilities
includes an increase in inventories of $41.5 million to support our growth, an
increase in accounts receivable of $22.9 million, and an increase in prepaid
expenses and other current and non-current assets of $5.8 million. This was
partially offset by an increase in accrued expenses and other non-current
liabilities of $5.0 million.
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 a decrease in accounts receivable of $6.8 million and other
non-current liabilities of $5.1 million.
Net Cash Provided By (Used In) Investing Activities
Net cash provided by (used in) investing activities relates primarily to
proceeds from maturities and sales of marketable investments, net of purchases,
and capital expenditures.
Net cash provided by investing activities was $29.4 million during the six
months ended June 30, 2021 and primarily consisted of proceeds from maturities
and sales of marketable investments, net purchases, of $36.9 million, partially
offset by capital expenditures of $7.3 million.
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 Financing Activities
Net cash provided by 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.
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Net cash provided by financing activities was $0.6 million during the six months
ended June 30, 2021 and primarily consisted of proceeds from the issuance of
common stock under our employee stock purchase plan of $7.4 million and proceeds
from exercises of stock options of $1.0 million. This was partially offset by
$7.0 million of payments of employee taxes related to vested restricted stock
and restricted stock units and $0.7 million in payments towards finance leases.
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.
Contractual Obligations and Commitments
On September 3, 2019, we entered into a lease of certain property in the Harbor
Bay Business Park in Alameda, California,(the "1310 Harbor Bay Lease") for a
fifteen year term which commenced during the three months ended June 30, 2021.
The fixed lease payments for base rent total approximately $3.5 million in the
first year of the 1310 Harbor Bay Lease, including a two-month rent abatement
period during the first year. The total estimated lease payments over the
fifteen year lease term are approximately $77 million. We have the option to
renew the lease for an additional five, ten or fifteen years.
During the three months ended June 30, 2021, we entered into a $7.3 million
non-cancelable supply agreement to purchase a fixed amount of materials used in
our manufacturing process.
There have been no other material changes to our contractual obligations and
commitments as of June 30, 2021 from those disclosed in our Annual Report on
Form 10-K for the year ended December 31, 2020.
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, 2020.
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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