Information pertaining to fiscal year 2017 was included in the Company's Annual
Report on Form
10-K
("Form
 10-K")
for the year ended December 31, 2018 on pages 30 through 43 under Part II, Item
7, "Management's Discussion and Analysis of Financial Condition and Results of
Operations," which was filed with the SEC on March 1, 2019.
Repligen and its subsidiaries, collectively doing business as Repligen
Corporation ("Repligen", "we", "our", or "the Company") is a global life
sciences company that develops and commercializes highly innovated bioprocessing
technology and systems that increase efficiencies and flexibility in the process
of manufacturing biological drugs. As the overall market for biologics continues
to grow and expand, our customers - primarily large biopharmaceutical companies
and contract development and manufacturing organizations - face critical
production cost, capacity, quality and time pressures. Built to address these
concerns, our products helping set new standards for the way biologics are
manufactured. We are committed to inspiring advances in bioprocessing as a
trusted partner in the production of critical biologic drugs - including
monoclonal antibodies, recombinant proteins, vaccines and gene therapies - that
are improving human health worldwide.
Our Chromatography products feature
pre-packed
chromatography columns under our OPUS
®
brand. OPUS columns, which we deliver to our customers
pre-packed
with their choice of chromatography resin, are single-campaign
("single-use")
disposable columns that replace the use of traditional (more permanent) glass
columns used in downstream purification and quality control of biological drugs.
By designing OPUS columns as an advanced and flexible option for the
purification of biologics from process development through clinical-scale and
some commercial manufacturing, Repligen has become a leader in
pre-packed
columns ("PPC").
Our Filtration products offer a number of advantages to manufacturers of
biologic drugs at volumes that span from pilot studies to clinical and
commercial-scale production. XCell ATF
™
systems are alternating tangential flow ("ATF") and used primarily in upstream
perfusion (continuous manufacturing) processes to increase cell concentration
and significantly improve biologic product yield from a bioreactor. To address
increasing industry demand for
"plug-and-play"
technology, we developed and launched
single-use
formats of the original stainless steel XCell ATF device. In December 2016, we
acquired TangenX Technology Corporation ("TangenX"), balancing our upstream
XCell ATF offering with a downstream portfolio of TangenX
™
Flat Sheet Cassettes used in biologic drug purification and formulation
processes. The TangenX portfolio includes the
single-use
SIUS
™
TFF cassettes, providing customers with a high-performance,
low-cost
alternative to reusable TFF cassettes. We acquired Spectrum Life Sciences LLC
("Spectrum") and its subsidiaries in August 2017 to strengthen our filtration
business with the addition of a leading portfolio of Spectrum
®
Hollow Fibers. Spectrum brands include the KrosFlo
®
TFF systems with Konduit monitor and ProConnex
®
single-use,
flow-path assemblies. We also gained the Spectra/Por
®
portfolio of laboratory and process dialysis products and in 2019, we launched
the SpectraFlo
™
Dynamic Dialysis Systems, and the KrosFlo
®
TFDF
™
(Tangential Flow Depth Filtration) Systems, which we believe has the potential
to disrupt and displace transitional harvest clarification operations. With the
acquisition of Spectrum, we substantially increased our direct sales presence in
Europe and Asia, and we diversified our end markets beyond monoclonal antibodies
("mAb") to include vaccines, recombinant proteins and gene therapies.
We are a leading supplier of Protein A affinity ligands to life sciences
companies. Protein A affinity ligands are an essential "binding" component of
Protein A chromatography resins used in the purification of virtually all
mAb-based
drugs on the market or in development. We manufacture multiple forms of Protein
A affinity ligands under long-term supply agreements with major life sciences
companies who in turn sell their Protein A chromatography resins to end users
(mAb manufacturers).
Customers use our products to produce initial quantities of drug for clinical
studies and then
scale-up
to larger volumes as the drug progresses to commercial production following
regulatory approval. Detailed specifications
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for a drug's manufacturing process are included in the applications that
biopharmaceutical companies file for marketing approval with regulators, such as
the U.S. Food and Drug Administration and the European Medicines Agency,
throughout the clinical trial process and prior to final commercial approval. As
a result, products that become part of the manufacturing specifications of a
late-stage clinical or commercial process can be very sensitive given the costs
and uncertainties associated with displacing them.
C Technologies, Inc. Acquisition
On April 25, 2019, we entered into a Stock Purchase Agreement ("Purchase
Agreement") with C Technologies, Inc. ("C Technologies"), a New Jersey
corporation, and Craig Harrison, an individual and sole stockholder of C
Technologies. The deal was consummated on May 31, 2019 (the "C Technologies
Acquisition").
C Technologies sells instruments, consumables and accessories that are designed
to allow bioprocessing technicians to measure the protein concentration of a
liquid sample using C Technologies' Slope Spectroscopy
®
method, which eliminates the need for manual sample dilution. C Technologies'
lead product, the SoloVPE
®
Device, was launched in 2008 for
off-line
and
at-line
protein concentration measurements conducted in quality control, process
development and manufacturing labs in the production of biological therapeutics.
C Technologies' FlowVPE
®
Device, an extension of the SoloVPE technology, was designed to allow end users
to make
in-line
protein concentration measurements in filtration, chromatography and fill-finish
applications, designed to allow for real-time process monitoring.
The C Technologies Acquisition was accounted for as a purchase of a business
under Accounting Standard Codification No. ("ASC") 805,
"Business Combinations."
The cash paid for the C Technologies Acquisition was $195.0 million,
$186.0 million of which will be consideration transferred pursuant to ASC 805,
and $9.0 million of which will be compensation expense for future employment,
and 779,221 of unregistered common shares totaling $53.9 million (based on a per
share price of $69.22), for a total purchase price of $239.9 million.
Critical Accounting Policies and Estimates
While our significant accounting policies are more fully described in the notes
to our consolidated financial statements, we have identified the policies and
estimates below as being critical to our business operations and the
understanding of our results of operations. These policies require management's
most difficult, subjective or complex judgements, often as a result of the need
to make estimates about the effect of matters that are inherently uncertain. The
impact of and any associated risks related to these policies on our business
operations are discussed throughout "Management's Discussion and Analysis of
Financial Condition," including in the "Results of Operations" section, where
such policies affect our reported and expected financial results. Although we
believe that our estimates, assumptions, and judgements are reasonable, they are
based upon information presently available. Actual results may differ
significantly from these estimates under different assumptions, judgments, or
conditions.
Revenue recognition
We generate revenue from the sale of bioprocessing products, equipment devices,
and related consumables used with these equipment devices to customers in the
life science and biopharmaceutical industries. Under ASC 606, "
Revenue from Contracts with Customers,"
revenue is recognized when, or as, obligations under the terms of a contract are
satisfied, which occurs when control of the promised products or services is
transferred to customers. Revenue is measured as the amount of consideration the
Company expects to receive in exchange for transferring products or services to
a customer ("transaction price"). To the extent the transaction price includes
variable consideration, the Company estimates the amount of variable
consideration that should be included in the transaction price utilizing the
expected value method or the most likely amount method, depending on the facts
and circumstances relative to the contract. Variable consideration is included
in the transaction price if, in the Company's judgment, it is probable that a
significant future reversal of cumulative revenue under the contract
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will not occur. Estimates of variable consideration and determination of whether
to include estimated amounts in the transaction price are based largely on an
assessment of the Company's anticipated performance and all information
(historical, current and forecasted) that is reasonably available. Sales, value
add, and other taxes collected on behalf of third parties are excluded from
revenue.
When determining the transaction price of a contract, an adjustment is made if
payment from a customer occurs either significantly before or significantly
after performance, resulting in a significant financing component. Applying the
practical expedient in paragraph
606-10-32-18,
the Company does not assess whether a significant financing component exists if
the period between when the Company performs its obligations under the contract
and when the customer pays is one year or less. None of the Company's contracts
contained a significant financing component as of December 31, 2019.
Contracts with customers may contain multiple performance obligations. For such
arrangements, the transaction price is allocated to each performance obligation
based on the estimated relative standalone selling prices of the promised
products or services underlying each performance obligation. The Company
determines standalone selling prices based on the price at which the performance
obligation is sold separately. If the standalone selling price is not observable
through past transactions, the Company estimates the standalone selling price
taking into account available information such as market conditions and
internally approved pricing guidelines related to the performance obligations.
The Company recognizes product revenue under the terms of each customer
agreement upon transfer of control to the customer, which occurs at a point in
time.
Inventories
We value inventory at cost or, if lower, net realizable value, using the
first-in,
first-out
method. We review our inventory at least quarterly and record a provision for
excess and obsolete inventory based on our estimates of expected sales volume,
production capacity and expiration dates of raw materials,
work-in-process
and finished products. Expected sales volumes are determined based on supply
forecasts provided by key customers for the next three to 12 months. We write
down inventory that has become obsolete, inventory that has a cost basis in
excess of its expected net realizable value, and inventory in excess of expected
requirements to cost of product revenue. Manufacturing of bioprocessing finished
goods is done to order and tested for quality specifications prior to shipment.
A change in the estimated timing or amount of demand for our products could
result in additional provisions for excess inventory quantities on hand. Any
significant unanticipated changes in demand or unexpected quality failures could
have a significant impact on the value of inventory and reported operating
results. During all periods presented in the accompanying consolidated financial
statements, there have been no material adjustments related to a revised
estimate of inventory valuations.
Business combinations
Amounts paid for acquisitions are allocated to the tangible and intangible
assets acquired and liabilities assumed, if any, based on their fair values at
the dates of acquisition. This purchase price allocation process requires
management to make significant estimates and assumptions with respect to
intangible assets and deferred revenue obligations. The fair value of
identifiable intangible assets is based on detailed valuations that use
information and assumptions determined by management. Any excess of purchase
price over the fair value of the net tangible and intangible assets acquired is
allocated to goodwill. While we use our best estimates and assumptions to
accurately value assets acquired and liabilities assumed at the acquisition date
as well as any contingent consideration, where applicable, our estimates are
inherently uncertain and subject to refinement. As a result, during the
measurement period, which may be up to one year from the acquisition date, we
record adjustments to the assets acquired and liabilities assumed with the
corresponding offset to goodwill. Upon
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conclusion of the measurement period or final determination of the values of
assets acquired or liabilities assumed, whichever comes first, any subsequent
adjustments are recorded to our consolidated statements of comprehensive income.
The fair value of contingent consideration includes estimates and judgments made
by management regarding the probability that future contingent payments will be
made, the extent of royalties to be earned in excess of the defined minimum
royalties, etc. Management updates these estimates and the related fair value of
contingent consideration at each reporting period based on the estimated
probability of achieving the earnout targets and applying a discount rate that
captures the risk associated with the expected contingent payments. To the
extent our estimates change in the future regarding the likelihood of achieving
these targets we may need to record material adjustments to our accrued
contingent consideration. Changes in the fair value of contingent consideration
are recorded in our consolidated statements of comprehensive income.
We use the income approach to determine the fair value of certain identifiable
intangible assets including customer relationships and developed technology.
This approach determines fair value by estimating
after-tax
cash flows attributable to these assets over their respective useful lives and
then discounting these
after-tax
cash flows back to a present value. We base our assumptions on estimates of
future cash flows, expected growth rates, expected trends in technology, etc. We
base the discount rates used to arrive at a present value as of the date of
acquisition on the time value of money and certain industry-specific risk
factors. We believe the estimated purchased customer relationships, developed
technologies, trademark / tradename, patents, and in process research and
development amounts so determined represent the fair value at the date of
acquisition and do not exceed the amount a third party would pay for the assets.
Intangible assets and goodwill
Intangible assets
Intangible assets with a definite life are amortized over their useful lives
using the straight-line method and the amortization expense is recorded within
cost of product revenue and selling, general and administrative expense in the
consolidated statements of comprehensive income. Intangible assets and their
related useful lives are reviewed at least annually to determine if any adverse
conditions exist that would indicate the carrying value of these assets may not
be recoverable. More frequent impairment assessments are conducted if certain
conditions exist, including a change in the competitive landscape, any internal
decisions to pursue new or different technology strategies, a loss of a
significant customer, or a significant change in the marketplace, including
changes in the prices paid for the Company's products or changes in the size of
the market for the Company's products. If impairment indicators are present, the
Company determines whether the underlying intangible asset is recoverable
through estimated future undiscounted cash flows. If the asset is not found to
be recoverable, it is written down to the estimated fair value of the asset
based on the sum of the future discounted cash flows expected to result from the
use and disposition of the asset. If the estimate of an intangible asset's
remaining useful life is changed, the remaining carrying amount of the
intangible asset is amortized prospectively over the revised remaining useful
life. The Company continues to believe that its definite-lived intangible assets
are recoverable at December 31, 2019.
Indefinite-lived intangible assets are tested for impairment at least annually.
There has been no impairment of our intangible assets for the periods presented.
Goodwill
We test goodwill for impairment on an annual basis and between annual tests if
events and circumstances indicate it is more likely than not that the fair value
of a reporting unit is less than its carrying value. Events that would indicate
impairment and trigger an interim impairment assessment include, but are not
limited to, current economic and market conditions, including a decline in
market capitalization, a significant adverse change in legal factors, business
climate or operational performance of the business, and an adverse action or
assessment by a regulator. Goodwill is tested for impairment as of December 31
st
of each year, or more frequently as warranted
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by events or changes in circumstances mentioned above. Accounting guidance also
permits an optional qualitative assessment for goodwill to determine whether it
is more likely than not that the carrying value of a reporting unit exceeds its
fair value. If, after this qualitative assessment, we determine that it is not
more likely than not that the fair value of a reporting unit is less than its
carrying amount, then no further quantitative testing would be necessary. A
quantitative assessment is performed if the qualitative assessment results in a
more likely than not determination or if a qualitative assessment is not
performed. The quantitative assessment considers whether the carrying amount of
a reporting unit exceeds its fair value, in which case an impairment charge is
recorded to the extent the reporting unit's carrying value exceeds its fair
value.
As of December 31, 2018, the Company concluded that it operated as two reporting
units and performed the 2018 goodwill impairment test using two reporting units.
In 2019, the Company reorganized its reporting structure and changed the way the
Chief Operating Decision Maker ("CODM") views the Company's operations and
allocates its resources. As a result of the change in reporting structure in
2019, the CODM reviews consolidated results to assist with decision making.
Accordingly, the Company operates as one reporting unit as of the goodwill
impairment measurement date of December 31, 2019. The fair value of the
reporting unit is determined using both an income approach and market approach.
Our income approach model used for our reporting unit valuation is consistent
with that used for our December 31, 2018 goodwill impairment valuation noted
above except that cash flows from the entire business enterprise are used for
the reporting unit valuation. Our market approach model estimates the fair value
of the reporting unit based on market prices paid in actual precedent
transactions of similar businesses and market multiples of guideline public
companies.
As a result of our 2019 quantitative assessment, we concluded that goodwill is
not impaired as of December 31, 2019.
Accrued liabilities
We estimate accrued liabilities by identifying services performed on our behalf,
estimating the level of service performed and determining the associated cost
incurred for such service as of each balance sheet date. For example, we would
accrue for professional and consulting fees incurred with law firms, audit and
accounting service providers and other third-party consultants. These expenses
are determined by either requesting those service providers to estimate unbilled
services at each reporting date for services incurred or tracking costs incurred
by service providers under fixed fee arrangements.
We have processes in place to estimate the appropriate amounts to record for
accrued liabilities, which principally involve the applicable personnel
reviewing the services provided. In the event that we do not identify certain
costs that have begun to be incurred or we under or over-estimate the level of
services performed or the costs of such services, the reported expenses for that
period may be too low or too high. The date on which certain services commence,
the level of services performed on or before a given date, and the cost of such
services often require the exercise of judgment. We make these judgments based
upon the facts and circumstances known at the date of the financial statements.
A change in the estimated cost or volume of services provided could result in
additional accrued liabilities. Any significant unanticipated changes in such
estimates could have a significant impact on our accrued liabilities and
reported operating results. There have been no material adjustments to our
accrued liabilities in any of the periods presented in the accompanying
consolidated financial statements.
Debt accounting
Our long-term debt balance is related to our 0.375% Convertible Senior Notes due
2024 (the "2019 Notes"), which were issued in July 2019 and are carried at their
principal amount less unamortized debt discount. We account for our convertible
notes as separate liability and equity components. We estimate the carrying
amount of the liability component by estimating the fair value of a similar
liability that does not have an associated conversion feature. The Company
allocates transaction costs related to the issuance of convertible notes to the
liability and equity components using the same proportions as the initial
carrying value of the convertible notes.
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The carrying value of the equity component is calculated by deducting the
carrying value of the liability component from the principal amount of the
convertible notes as a whole. The difference represents a debt discount that is
amortized to interest expense in our consolidated statement of comprehensive
income over the term of the convertible notes using the effective interest rate
method. We assess the equity classification of the cash conversion feature
quarterly. We allocated transaction costs related to the issuance of the 2019
Notes to the liability and equity components using the same proportions as the
initial carrying value of the 2019 Notes.
Stock-based compensation
We use the Black-Scholes option pricing model to calculate the fair value of
stock option awards on the grant date. The expected term of options granted
represents the period of time for which the options are expected to be
outstanding and is derived from our historical stock option exercise experience
and option expiration data. For purposes of estimating the expected term, we
have aggregated all individual option awards into one group, as we do not expect
substantial differences in exercise behavior among our employees. The expected
volatility is a measure of the amount by which our stock price is expected to
fluctuate during the expected term of options granted. We determined the
expected volatility based upon the historical volatility of our common stock
over a period commensurate with the option's expected term. The risk-free
interest rate is the implied yield available on U.S. Treasury
zero-coupon
issues with a remaining term equal to the option's expected term on the grant
date. We have never declared or paid any cash dividends on any of our capital
stock and do not expect to do so in the foreseeable future. Accordingly, we use
an expected dividend yield of zero to calculate the grant-date fair value of a
stock option.
The fair value of stock units, which includes restricted stock units and
performance stock units, is calculated using the closing price of the Company's
common stock on the date of grant. We recognize compensation expense on awards
that vest based on service conditions on a straight-line basis over the
requisite service period based upon the number of options that are ultimately
expected to vest, and accordingly, such compensation expense has been adjusted
by an amount of estimated forfeitures. We recognize compensation expense on
awards that vest based on performance conditions following our assessment of the
probability that the performance condition will be achieved over the service
period. Forfeitures represent only the unvested portion of a surrendered option.
Forfeitures are estimated at the time of grant and revised, if necessary, in
subsequent periods if actual forfeitures differ from those estimates. Based on
an analysis of historical data, we have calculated an 8% annual forfeiture rate
for
non-executive
level employees, a 3% annual forfeiture rate for executive level employees, and
a 0% forfeiture rate for
non-employee
members of the Board of Directors, which we believe are reasonable assumptions
to estimate forfeitures. However, the estimation of forfeitures requires
significant judgment and, to the extent actual results or updated estimates
differ from our current estimates, such amounts will be recorded as a cumulative
adjustment in the period estimates are revised.
For the years ended December 31, 2019, 2018 and 2017, we recorded stock-based
compensation expense of $12.8 million, $10.2 million and $6.7 million,
respectively, for share-based awards granted under all of the Company's stock
plans.
As of December 31, 2019, there was $36.4 million of total unrecognized
compensation cost related to unvested share-based awards. This cost is expected
to be recognized over a weighted average remaining requisite service period of
4.09 years. We expect 1,688,497 unvested options and stock units to vest over
the next five years.
Income taxes
Deferred taxes are determined based on the difference between the financial
statement and tax basis of assets and liabilities using enacted tax rates in
effect in the years in which the differences are expected to reverse. Valuation
allowances are provided, if, based upon the weight of available evidence, it is
more likely than not that some or all of the deferred tax assets will not be
realized. We account for uncertain tax positions using a "more-likely-
than-not"
threshold for recognizing and resolving uncertain tax positions. The evaluation
of uncertain tax
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positions is based on factors including, but not limited to, changes in tax law,
the measurement of tax positions taken or expected to be taken in tax returns,
the effective settlement of matters subject to audit, new audit activity and
changes in facts or circumstances related to a tax position. We evaluate our tax
position on a quarterly basis. We also accrue for potential interest and
penalties related to unrecognized tax benefits in income tax expense.
In addition, we are subject to the continual examination of our income tax
returns by the U.S. Internal Revenue Service ("IRS") and other domestic and
foreign tax authorities. We expect future examinations to focus on our
intercompany transfer pricing practices as well as other matters. We regularly
assess the likelihood of outcomes resulting from these examinations to determine
the adequacy of our provision for income taxes and have reserved for potential
adjustments that may result from such examinations. We believe such estimates to
be reasonable; however, the final determination of any of these examinations
could significantly impact the amounts provided for income taxes in our
consolidated financial statements.
Recent accounting standards update
See Note 2,
"Summary of Significant Accounting Policies - Recent Accounting Standards
Updates,"
to our consolidated financial statements included in this report for more
information.
Results of Operations
The following discussion of the financial condition and results of operations
should be read in conjunction with the accompanying consolidated financial
statements and the related footnotes thereto.
Revenues
Total revenues for years ended December 31, 2019, 2018, and 2017 were comprised
of the following:

                                 For the Years Ended December 31,               2019 vs. 2018                2018 vs. 2017
                                2019             2018          2017        $ Change       % Change      $ Change       % Change
                                                     (Amounts in thousands, except for percentage data)
Revenue:
Product                      $   270,097       $ 193,891     $ 141,089     $  76,206           39.3 %   $  52,802           37.4 %
Royalty and other                    148             141           147             7            5.0 %          (6 )         (4.1 %)

Total revenue                $   270,245       $ 194,032     $ 141,236     $  76,213           39.3 %   $  52,796           37.4 %




Product revenues
Since 2016, we have been increasingly focused on selling our products directly
to customers in the pharmaceutical industry and to our contract manufacturers.
These direct sales have increased to approximately 76% of our product revenue
during 2019. We expect that direct sales will continue to account for an
increasing percentage of our product revenues, as the largest customer of our
OEM products diversifies its supply chain starting in 2020. Sales of our
bioprocessing products can be impacted by the timing of large-scale production
orders and the regulatory approvals for such antibodies, which may result in
significant quarterly fluctuations.
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Product revenues were comprised of the following:

                                 For the Years Ended December 31,
                                2019                           2017
                                 (1)             2018           (2)
                                      (Amounts in thousands)
Chromatography products      $    64,635       $  45,326     $  36,309
Filtration products              119,534          90,586        49,050
Process analytics products        16,405              -             -
Proteins products                 65,124          54,375        53,969
Other                              4,399           3,604         1,761

Total product revenue        $   270,097       $ 193,891     $ 141,089

(1) 2019 revenue includes process analytics revenue related to C Technologies

from June 1, 2019 through December 31, 2019.

(2) 2017 revenue for filtration, chromatography and other products includes

revenue related to Spectrum from August 1, 2017 through December 31, 2017.





Revenue from our chromatography products includes the sale of our OPUS
chromatography columns, chromatography resins and ELISA test kits. Revenue from
our filtration products includes the sale of our XCell ATF systems and
consumables, KrosFlo filtration products and SIUS filtration products. Revenue
from protein products includes the sale of our Protein A ligands and cell
culture growth factors. Revenue from our Process Analytics products includes the
sale of our SoloVPE and FlowVPE systems and consumables. Other revenue primarily
consists of revenue from the sale of our operating room products to hospitals as
well as freight revenue.
For 2019, product revenue increased by $76.2 million, or 39%, as compared to
2018. The increase is due to the continued adoption of our products by our key
bioprocessing customers, particularly our chromatography and filtration
products. Sales of our bioprocessing products are impacted by the timing of
orders, development efforts at our customers or
end-users
and regulatory approvals for biologics that incorporate our products, which may
result in significant quarterly fluctuations. Such quarterly fluctuations are
expected, but they may not be predictive of future revenue or otherwise indicate
a trend. Additionally, there was a $16.4 million increase in the 2019 revenue
compared to the 2018 revenue due to revenues generated by C Technologies.
For 2018, product revenue increased by $52.8 million, or 37%, as compared to
2017. The increase is due to the continued adoption of our products by our key
bioprocessing customers and a full year of revenues derived from our acquisition
of Spectrum in August 2017.
Royalty revenues
Royalty revenues in 2019 and 2018 relate to royalties received from a
third-party systems manufacturer associated with our OPUS chromatography
columns. Royalty revenues are variable and are dependent on sales generated by
our partner.
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Costs and operating expenses
Total costs and operating expenses for years ended December 31, 2019, 2018 and
2017 were comprised of the following:

                                    For the Years Ended December 31,               2019 vs. 2018                2018 vs. 2017
                                   2019             2018          2017        $ Change       % Change      $ Change       % Change
                                                        (Amounts in thousands, except for percentage data)
Cost of product revenue         $   119,099       $  86,531     $  67,050     $  32,568           37.6 %   $  19,481           29.1 %
Research and development             19,450          15,821         8,672         3,629           22.9 %       7,149           82.4 %
Selling, general and
administrative                       95,613          65,692        51,509        29,921           45.5 %      14,183           27.5 %

Total costs and operating
expenses                        $   234,162       $ 168,044     $ 127,231     $  66,118           39.3 %   $  40,813           32.1 %




Cost of product revenue
For 2019 and 2018, cost of product revenue increased $32.6 million, or 38%, and
$19.5 million, or 29%, respectively, as compared to 2018 and 2017, due primarily
to the increase in revenue mentioned above. Gross margins may fluctuate in
future quarters based on expected production volume and product mix.
Gross margins were 56%, 55%, and 53% for 2019, 2018 and 2017, respectively. The
gross margin in 2019 includes $1.5 million of amortization on an inventory
step-up
recorded in purchase accounting related to the C Technologies Acquisition. The
increase in gross margins is a result of higher product revenue mentioned above
offset by an increase in costs associated with additional manufacturing
headcount in 2019, as compared to 2018. Gross margins may fluctuate in future
quarters based on expected production volume and product mix. During 2018, gross
margins increased compared to 2017 primarily due to higher product revenue.
Research and development expenses
During 2019, 2018 and 2017, research and development ("R&D") expenses were
related to bioprocessing products, including personnel, supplies and other
research expenses. Due to the size of the Company and the fact that these
various programs share personnel and fixed costs, we do not track all of our
expenses or allocate any fixed costs by program, and therefore, have not
provided historical costs incurred by project. In addition to the legacy product
research and development, the current
single-use
XCell ATF technology incurs expenses related to product development,
sterilization, validation testing, and other research related expenses.
R&D expenses increased $3.6 million in 2019, or 23%, compared to 2018. The
increase is primarily due to an increase in costs associated with an increase in
R&D headcount, an increase in stock-based compensation expense resulting from
the increased headcount and the higher share price period over period, and to
the addition of $1.7 million of R&D expenses related to C Technologies, which
was acquired in May 2019.
The increase in 2019 was partially offset by a $1.4 million decrease in R&D
expense for investments made to expand our proteins product offering through our
development agreement with Navigo Proteins GmbH ("Navigo"). The Company invested
$1.0 million in 2019 compared to $2.4 million in 2018.
For 2018, R&D expenses increased by $7.1 million, or 82%, as compared to 2017.
This increase is primarily driven by investments made during 2018 to expand our
proteins product offerings through our development agreement with Navigo.
Additionally, the increase is related to product development activities acquired
as part of the Spectrum acquisition and increased activity in our various
bioprocessing development projects.
We expect our R&D expenses in the year ending December 31, 2020 to increase in
order to support new product development.
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Selling, general and administrative expenses
Selling, general and administrative ("SG&A") expenses include the costs
associated with selling our commercial products and costs required to support
our marketing efforts, including legal, accounting, patent, shareholder
services, amortization of intangible assets and other administrative functions.
For 2019, SG&A costs increased by $29.9 million, or 46%, as compared to 2018.
The increase is due to the addition of $10.9 million of SG&A costs from the
acquisition of C Technologies in May 2019, as well as the continued expansion of
our customer-facing activities to drive sales of our bioprocessing products, and
to the continued buildout of our administrative infrastructure, primarily
through increased headcount, to support expected future growth. In addition,
during 2019, transaction fees related to the C Technologies Acquisition of
$4.0 million were included in SG&A, for which there were no comparable costs for
2018. Sales commissions were higher in 2019 due to the increase in revenue.
Stock compensation expense increased as compared to 2018 resulting from the
increase in headcount and higher share prices period over period.
For 2018, SG&A costs increased by $14.2 million, or 28%, as compared to 2017.
The increase is due to selling and administrative activities incurred following
the Spectrum acquisition, as well as the continued buildout of our
administrative infrastructure to support expected future growth and continued
expansion of our customer-facing activities to drive sales of our bioprocessing
products.
Other expenses, net
The table below provides detail regarding our other expenses, net:

                                        For the Years Ended December 31,                 2019 vs. 2018                   2018 vs. 2017
                                     2019              2018            2017         $ Change       % Change         $ Change       % Change
                                                              (Amounts in thousands, except for percentage data)
Investment income                 $     5,324       $     1,895      $     

371 $ 3,429 180.9 % $ 1,524 410.8 % Loss on extinguishment of debt (5,650 )

              -              -          (5,650 )        100.0 %             -             N/A
Interest expense                       (9,292 )          (6,709 )       (6,441 )       (2,583 )         38.5 %           (268 )          4.2 %
Other (expenses) income                  (314 )             262           (687 )         (576 )       (219.8 %)           949         (138.1 %)


Total other expenses, net         $    (9,932 )     $    (4,552 )    $  (6,757 )    $  (5,380 )       118.2. %     $    2,205          (32.6 %)




Investment income
Investment income includes income earned on invested cash balances. The increase
of $3.4 million for 2019 and $1.5 million for 2018, as compared to 2018 and 2017
was attributable to higher average invested cash balances and higher interest
rates on such invested cash balances. We expect investment income to vary based
on changes in the amount of funds invested and fluctuation of interest rates.
Loss on extinguishment of debt
The $5.7 million loss on extinguishment of debt for the year ended December 31,
2019 resulted from the settlement of our outstanding 2.125% Convertible Senior
Notes due 2021 (the "2016 Notes") in the third quarter of 2019. The loss
represents the difference between (i) the fair value of the liability component
and (ii) the sum of the carrying value of the debt component and any unamortized
debt issuance costs at the time of settlement.
Interest expense
Interest expense primarily includes interest related to our issuance of the 2016
Notes in May 2016, which were settled during the third quarter of 2019, and our
issuance of 0.375% Convertible Senior Notes due 2024 (the "2019 Notes"), which
were issued in July 2019. Interest expense increased $2.6 million in 2019, as
compared to
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2018. Interest calculated based on the carrying value related to the 2016 Notes
was $1.3 million in 2019, compared to $2.4 million in 2018. As aforementioned,
the 2016 Notes were settled during July 2019. As a result, interest was no
longer accrued on the 2016 Notes subsequent to their settlement. Interest
calculated based on the carrying value related to the 2019 Notes for 2019 was
$0.5 million and there was no comparable amount for 2018.
The amortization of the debt issuance costs on the 2016 Notes was $2.8 million
for 2019, compared to $4.5 million for 2018. The decrease in this amortization
is a result of the settlement of the 2016 Notes and subsequent
write-off
of the remaining debt issuance costs in July 2019. Amortization of debt issuance
costs on the 2019 Notes was $4.7 million in 2019. There were no comparable
amounts in 2018 as the 2019 Notes were issued in July 2019.
Other (expenses) income
Changes in other (expenses) income during 2019, compared to 2018, are primarily
attributable to foreign currency losses related to amounts due from
non-Swedish
krona-based customers and cash balance denominated in U.S. dollars and British
pounds held by Repligen Sweden AB. In addition, $0.5 million was included in
other (expenses) income in 2019, which represents a bridge loan commitment fee
incurred as part of the C Technologies Acquisition.
Provision for income taxes
Income tax provision for the years ended December 31, 2019, 2018 and 2017 was as
follows:

                                    For the Years Ended December 31,                 2019 vs. 2018                  2018 vs. 2017
                                  2019             2018           2017          $ Change        % Change       $ Change      % Change
                                                         (Amounts in thousands, except for percentage data)
Income tax provision           $    4,740       $    4,819       $(21,105 )           $(79 )         (1.6 %)   $  25,924        (122.8 %)
Effective tax rate                   18.1 %           22.5 %       (291.2 %)



For the year ended December 31, 2019, we recorded an income tax provision of
approximately $4.7 million. The effective tax rate was an income tax provision
of 18.1% and is based upon the estimated taxable income for the year ending
December 31, 2019 and the composition of the taxable income in different
jurisdictions. The effective tax rate was lower than the U.S. statutory rate of
21% due primarily to windfall benefits on stock option exercises and the vesting
of restricted stock units and to deductions related to debt extinguishment.
For the year ended December 31, 2018, we recorded an income tax provision of
$4.8 million. The effective tax rate was 22.5% in 2018 and is based upon the
estimated income from the year and the composition of the income in different
jurisdictions. The effective tax rate was higher than the U.S. statutory rate of
21% due to state tax effects and the impact of the Global Intangible
Low-Taxed
Income tax enacted as part of the Tax Cuts and Jobs Act (the "2017 Tax Act")
enacted in December 2017.
Non-GAAP
Financial Measures
We provide
non-GAAP
adjusted income from operations,
non-GAAP
adjusted net income and adjusted EBITDA as supplemental measures to GAAP
measures regarding our operating performance. These financial measures exclude
the impact of certain acquisition related items and, therefore, have not been
calculated in accordance with GAAP. A detailed explanation and a reconciliation
of each
non-GAAP
financial measures to its most comparable GAAP financial measures are described
below.
We include this financial information because we believe these measures provide
a more accurate comparison of our financial results between periods and more
accurately reflect how management reviews its financial results.
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We excluded the impact of certain acquisition related items because we believe
that the resulting charges do not accurately reflect the performance of our
ongoing operations for the period in which such charges are incurred.
Non-GAAP
adjusted income from operations
Non-GAAP
adjusted income from operations is measured by taking income from operations as
reported in accordance with GAAP and excluding acquisition and integration
costs, inventory
step-up
charges, intangible amortization and contingent consideration expenses booked
through our consolidated statements of comprehensive income. The following is a
reconciliation of income from operations in accordance with GAAP to
non-GAAP
adjusted income from operations for the years ended December 31, 2019 and 2018:

                                           For the Years Ended December 31,
                                              2019                  2018
                                                (Amounts in thousands)
GAAP income from operations              $        36,083       $        25,988
Non-GAAP
adjustments to income from operations:
Acquisition and integration costs                 12,508                 2,928
Inventory
step-up
charges                                            1,483                    -
Intangible amortization                           13,441                10,518

Non-GAAP

adjusted income from operations $ 63,515 $ 39,434







Non-GAAP
adjusted net income
Non-GAAP
adjusted net income is measured by taking net income as reported in accordance
with GAAP and excluding acquisition and integration costs and related tax
effects, inventory
step-up
charges, contingent consideration expenses, intangible amortization and related
tax effects,
non-cash
interest expense, the partial release of the valuation allowance on our deferred
tax assets and the net impact of tax reform legislation booked through our
consolidated statements of comprehensive income. The following is a
reconciliation of net income in accordance with GAAP to
non-GAAP
adjusted net income for the years ended December 31, 2019 and 2018:

                                                       For the Years Ended December 31,
                                                  2019                                  2018
                                                      Fully Diluted                        Fully Diluted
                                                      Earnings per                         Earnings per
                                      Amount             Share*             Amount            Share*
                                                (Amounts in thousands, except per share data)
GAAP net income                      $  21,411       $          0.44       $ 16,617       $          0.37
Non-GAAP
adjustments to net income:
Acquisition and integration
costs                                   13,008                  0.26          2,928                  0.06
Inventory
step-up
charges                                  1,483                  0.03             -                     -
Intangible amortization                 13,441                  0.27         10,518                  0.23
Loss on extinguishment of debt           5,650                  0.11             -                     -

Non-cash


interest expense                         7,536                  0.15          4,248                  0.09
Tax effect of intangible
amortization and acquisition
costs                                  (10,003 )               (0.20 )       (4,204 )               (0.09 )

Non-GAAP
adjusted net income                  $  52,526       $          1.07       $ 30,107       $          0.66





* Note that earnings per share amounts may not add due to rounding.


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Adjusted EBITDA
Adjusted EBITDA is measured by taking net income as reported in accordance with
GAAP, excluding investment income, interest expense, taxes, depreciation and
intangible amortization, and excluding acquisition and integration costs,
inventory
step-up
charges and contingent consideration expenses booked through our consolidated
statements of comprehensive income. The following is a reconciliation of net
income in accordance with GAAP to adjusted EBITDA for years ended December 31,
2019 and 2018:

                                                       For the Years Ended December 31,

                                                      2019                           2018

                                                           (Amounts in thousands)
GAAP net income                               $          21,411              $          16,617
Non-GAAP EBITDA adjustments to net
income:
Investment income                                        (5,324 )                       (1,895 )
Interest expense                                          9,292                          6,709
Tax provision                                             4,740                          4,819
Depreciation                                              7,317                          5,213
Intangible amortization                                  13,551                         10,565

EBITDA                                                   50,987                         42,028
Other non-GAAP adjustments:
Acquisition and integration costs                        13,008                          2,928
Loss on extinguishment of debt                            5,650                             -
Inventory step-up charges                                 1,483                             -

Adjusted EBITDA                               $          71,128              $          44,956





Liquidity and Capital Resources
We have financed our operations primarily through revenues derived from product
sales, the issuance of the 2016 Notes in May 2016 and our 2019 Notes (defined
below) in July 2019 and the issuance of common stock in our July 2019, May 2019
and July 2017 public offerings. Our revenue for the foreseeable future will
primarily be limited to our bioprocessing product revenue.
At December 31, 2019, we had cash and cash equivalents of $528.4 million
compared to cash and cash equivalents of $193.8 million at December 31, 2018. As
a result of our acquisition of C Technologies in May 2019, we are holding
$9.0 million in restricted cash for compensation expense for future employment
of C Technologies employees as of December 31, 2019. There were no restrictions
on cash for December 31, 2018.
We acquired C Technologies on May 31, 2019 for $239.9 million in cash and shares
of our common stock. The C Technologies Acquisition was funded through payment
of approximately $195.0 million in cash and 779,221 unregistered shares of the
Company's common stock totaling $53.9 million.
On May 3, 2019, the Company completed a public offering in which 3,144,531
shares of its common stock, including the underwriters' full exercise of an
option to purchase up to an additional 410,156 shares, were sold to the public
at a price of $64.00 per share. The total proceeds received by the Company from
this offering, net of underwriting discounts and commissions and other estimated
offering expenses payable by the Company, totaled approximately $189.6 million.
Proceeds from this public offering were partially used to fund the C
Technologies Acquisition on May 31, 2019.
On July 19, 2019, the Company completed a public offering in which 1,587,000
shares of its common stock, including the underwriters' full exercise of an
option to purchase an additional 207,000 shares, were sold to the public at a
price of $87.00 per share for $131.1 million in net proceeds to the Company,
after deducting underwriting discounts and commissions and other estimated
offering expenses payable by the Company (the "July Stock Offering").
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On July 19, 2019, the Company issued $287.5 million aggregate principal amount
of 0.375% Convertible Senior Notes due 2024 ("2019 Notes"), which includes the
underwriters' exercise in full of an option to purchase an additional
$37.5 million aggregate principal amount of 2019 Notes (the "Notes Offering"
and, together with the July Stock Offering, the "Offerings"). The net proceeds
of the Notes Offering, after deducting underwriting discounts and commissions
and other offering expenses payable by the Company, were $278.5 million. See
Note 11,
"Convertible Senior Notes,"
included in this report
for more information on this transaction. The Company utilized a portion of the
proceeds from the Offerings to settle its outstanding 2016 Notes during the
third quarter of 2019. On July 16, 2019, the Company entered into separate
privately negotiated agreements with certain holders of the 2016 Notes to
exchange an aggregate of $92.0 million principal aggregate amount of the 2016
Notes for shares of the Company's common stock, together with cash, in private
placement transactions (the "Note Exchanges"). On July 19, 2019 and July 22,
2019, the Company used approximately $92.3 million (including $0.3 million of
accrued interest) and 1,850,155 shares of its common stock valued at
$161.0 million to settle the Note Exchanges for total consideration of
$253.3 million, of which $163.6 million was allocated to the equity component of
the 2016 Notes. The Company allocated the consideration transferred to the
liability and equity components using the same proportions as the initial
carrying value of the 2016 Notes. The transaction resulted in a loss on
extinguishment of debt of $4.6 million in the Company's consolidated statements
of comprehensive income as of December 31, 2019.
During the fourth quarter of 2019, the closing price of the Company's common
stock did not exceed 130% of the conversion price of the 2019 Notes for more
than 20 trading days of the last 30 consecutive trading days of the quarter.
Therefore, the 2019 Notes are not convertible at the option of the holders of
the 2019 Notes during the first quarter of 2020 per the First Supplemental
Indenture underlying the 2019 Notes. The 2019 Notes have a face value of
$287.5 million and a carrying value of $232.8 million and are classified as
long-term liabilities on the Company's consolidated balance sheet as of
December 31, 2019.
In July 2017, we completed a public offering in which 2,807,017 shares of our
common stock were sold to the public at a price of $42.75 per share. The
underwriters were granted an option, which they exercised in full, to purchase
an additional 421,052 shares of our common stock. The total proceeds from this
offering, net of underwriting discounts, commissions and other offering
expenses, totaled $129.3 million.
On August 1, 2017, we completed our acquisition of Spectrum for $112.8 million
in cash (net of cash received) and 6,153,995 unregistered shares of the
Company's common stock.
Cash flows

                                      For the Years Ended December 31,             FY19 vs FY18        FY18 vs FY17
                                     2019             2018           2017            $ Change            $ Change
                                                               (Amounts in thousands)
Operating activities             $     67,216       $  32,770      $  17,451      $       34,446      $       15,319
Investing activities                 (205,308 )       (14,037 )      (98,696 )          (191,271 )            84,659
Financing activities                  484,867           3,407        129,945             481,460            (126,538 )
Effect of exchange rate
changes on cash, cash
equivalents and restricted
cash                                   (3,190 )        (2,077 )        2,376              (1,113 )            (4,453 )

Net increase in cash, cash
equivalents and restricted
cash                             $    343,585       $  20,063      $  51,076      $      323,522      $      (31,013 )





Operating activities
For 2019, our operating activities provided cash of $67.2 million reflecting net
income of $21.4 million and
non-cash
charges totaling $46.9 million primarily related to depreciation, amortization,
non-cash
interest expense, deferred taxes, loss on extinguishment of debt and stock-based
compensation charges. An increase in accounts receivable consumed $7.7 million
of cash and was primarily driven by the 39%
year-to-date
increase in
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revenues and an increase in inventory consumed $9.3 million to support future
revenue, due to the addition of C Technologies on May 31, 2019. These cash items
provided by operating activities were offset by cash items used for operating
activities that included an increase in accounts payable and accrued liabilities
of $13.8 million due to the addition of C Technologies and a decrease in
unbilled receivables of $2.1 million. The remaining cash used in operating
activities resulted from unfavorable changes in various other working capital
accounts.
For 2018, our operating activities provided cash of $32.8 million reflecting net
income of $16.6 million and
non-cash
charges totaling $30.3 million primarily related to depreciation, amortization,
non-cash
interest expense, deferred tax expense and stock-based compensation charges. An
increase in receivables consumed $8.7 million of cash and was primarily driven
by the 37%
year-to-date
increase in revenues. An increase in inventory levels to accommodate future
revenue growth consumed $4.0 million of cash, payment of accrued liabilities
consumed $1.4 million of cash and an increase in other assets used $1.8 million.
This utilization of cash is partially offset by $2.3 million of cash provided by
an increase in accounts payable due to the timing of payments to vendors. The
remaining cash flow used in operations resulted from net unfavorable changes in
various other working capital accounts.
For 2017, our operating activities provided cash of $17.5 million, reflecting
net income of $28.4 million offset by net
non-cash
charges totaling $3.4 million comprised mainly of depreciation, amortization,
stock-based compensation charges and deferred tax benefits. Increases in
accounts receivable consumed $6.9 million of cash, which is based on timing of
revenues billed to and payments from customers. Decreases in accounts payable
and accrued liabilities consumed $1.2 million of cash due to timing of payments
to vendors.
Investing activities
Our investing activities consumed $205.3 million of cash during 2019. We used
$182.2 million in cash (net of cash received) for the C Technologies Acquisition
on May 31, 2019. Capital expenditures consumed $23.2 million as we continue to
increase our manufacturing capacity worldwide. Of these expenditures,
$4.7 million represented capitalized costs related to our
internal-use
software.
For 2018, our investing activities consumed $14.0 million of cash, including
$12.8 million for capital expenditures. Of those expenditures, $2.1 million
represented capitalized costs related to our
internal-use
software. In addition, a capitalized payment for developed technology of
$1.3 million was paid to Navigo in 2018 to assist in expanding our proteins
product offerings through a development agreement.
For 2017, our investing activities consumed $98.7 million of cash. We used
$112.8 million in cash (net of cash received) for our acquisition of Spectrum.
Fixed asset additions consumed $5.5 million, as we continued to increase our
manufacturing capacity. Net redemptions of marketable securities provided
$19.6 million of cash in 2017.
Financing activities
In 2019, cash provided by financing activities of $487.1 million included
$320.7 million from the issuance of our common stock resulting from our public
offerings completed in May and July 2019. In addition, in July 2019 the Company
issued $287.5 million aggregate principal amount of the 2019 Notes for net
proceeds of $278.5 million. Proceeds from stock option exercises during 2019
were $1.2 million. Offsetting these activities was $115.0 million of cash
utilized by the Company in July 2019 to settle the 2016 Notes.
In 2018, our financing activities provided $3.4 million of cash. We received
proceeds of $3.4 million from stock option exercises, partially offset by cash
outlays of $11,000 related to the partial conversion of the 2016 Notes in the
first quarter of 2018.
In July 2017, we received net proceeds of $129.3 million from the issuance of
common stock. In May 2016, we received net proceeds of $111.1 million from the
issuance of the 2016 Notes. Exercises of stock options provided
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cash receipts of $2.4 million and $1.8 million in 2017 and 2016, respectively.
Cash payments to Atoll and Refine in 2017 totaled $5.1 million, of which
$1.7 million related to the fair value of these liabilities as of the respective
acquisition dates and is included as part of financing activities. Cash payments
to Refine and BioFlash in 2016 totaled $4.1 million, of which $0.8 million
related to the fair value of these liabilities as of the respective acquisition
dates and is included as part of financing activities. The remaining amounts are
included as an offset to our cash provided by operating activities.
Off-
Balance Sheet Arrangements
We do not have any special purpose entities or
off-balance
sheet financing arrangements.
Contractual Obligations
As of December 31, 2019, we had the following fixed obligations and commitments:

                                                   Less than         One to           Three to       Over five
                                      Total        one year        three years       five years        years
                                                              (Amounts in thousands)
Convertible senior notes            $ 287,500     $        -      $          -      $         -      $  287,500
Operating lease obligations            33,469           5,175            10,139            6,939         11,216
Purchase obligations
(1)                                    40,455          39,055             1,400               -              -

Total                               $ 361,424     $    44,230     $      11,539     $      6,939     $  298,716

(1) Primarily represents purchase commitments with certain vendors and open


    purchase orders for the procurement of raw materials for manufacturing.




The table excludes a liability for uncertain tax positions totaling $3.4 million
since we cannot currently make a reliable estimate of the period in which the
liability will be payable, if ever. Please see Note 8,
"Income Taxes,"
to our consolidated financial statements included in this report for more
information.
Capital Requirements
Our future capital requirements will depend on many factors, including the
following:
  • the expansion of our bioprocessing business;



• the ability to sustain sales and profits of our bioprocessing products;






  • our ability to acquire additional bioprocessing products;



• the scope of and progress made in our research and development activities;






  • the extent of any share repurchase activity; and




  • the success of any proposed financing efforts.




Absent acquisitions of additional products, product candidates or intellectual
property, we believe our current cash balances are adequate to meet our cash
needs for at least the next 24 months. We expect operating expenses in the year
ending December 31, 2020 to increase as we continue to expand our bioprocessing
business. We expect to incur continued spending related to the development and
expansion of our bioprocessing product lines and expansion of our commercial
capabilities for the foreseeable future. Our future capital requirements may
include, but are not limited to, purchases of property, plant and equipment, the
acquisition of additional bioprocessing products and technologies to complement
our existing manufacturing capabilities, and continued investment in our
intellectual property portfolio.
We plan to continue to invest in our bioprocessing business and in key research
and development activities associated with the development of new bioprocessing
products. We actively evaluate various strategic
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transactions on an ongoing basis, including licensing or acquiring complementary
products, technologies or businesses that would complement our existing
portfolio. We continue to seek to acquire such potential assets that may offer
us the best opportunity to create value for our shareholders. In order to
acquire such assets, we may need to seek additional financing to fund these
investments. If our available cash balances and anticipated cash flow from
operations are insufficient to satisfy our liquidity requirements, including
because of any such acquisition-related financing needs or lower demand for our
products, we may seek to sell common or preferred equity or convertible debt
securities, enter into a credit facility or another form of third-party funding,
or seek other debt funding. The sale of equity and convertible debt securities
may result in dilution to our stockholders, and those securities may have rights
senior to those of our common shares. If we raise additional funds through the
issuance of preferred stock, convertible debt securities or other debt
financing, these securities or other debt could contain covenants that would
restrict our operations. Any other third-party funding arrangement could require
us to relinquish valuable rights. We may require additional capital beyond our
currently anticipated amounts. Additional capital may not be available on
reasonable terms, if at all.
Net Operating Loss Carryforwards
At December 31, 2019, we had net operating loss carryforwards of $0.2 million
remaining. We had business tax credits carryforwards of $2.1 million available
to reduce future federal income taxes, if any. The business tax credits
carryforwards will continue to expire at various dates through December 2039.
Net operating loss carryforwards and available tax credits are subject to review
and possible adjustment by the Internal Revenue Service, state and foreign
jurisdictions and may be limited in the event of certain changes in the
ownership interest of significant stockholders.
Foreign Earnings
As of December 31, 2019, the Company has accumulated undistributed earnings
generated by our foreign subsidiaries of approximately $93.5 million. Because
$58.0 million of such earnings have previously been subject to the
one-time
transition tax on foreign earnings required by the 2017 Tax Act, any additional
taxes due with respect to such earnings or the excess of the amount for
financial reporting over the tax basis of our foreign investments would
generally be limited to foreign and state taxes. At December 31, 2019, we have
not provided for taxes on outside basis differences of our foreign subsidiaries,
as we have the ability and intent to indefinitely reinvest the undistributed
earnings of our foreign subsidiaries, and there are no needs for such earnings
in the United States that would contradict our plan to indefinitely reinvest.
Effects of Inflation
Our assets are primarily monetary, consisting of cash and cash equivalents.
Because of their liquidity, these assets are not directly affected by inflation.
Since we intend to retain and continue to use our equipment, furniture, fixtures
and office equipment, computer hardware and software and leasehold improvements,
we believe that the incremental inflation related to replacement costs of such
items will not materially affect our operations. However, the rate of inflation
affects our expenses, such as those for employee compensation and contract
services, which could increase our level of expenses and the rate at which we
use our resources.

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