NASHVILLE, Tenn., May 4, 2021 /PRNewswire/ -- Cryoport, Inc.
(NASDAQ: CYRX) ("Cryoport" or the "Company"), a global leader
in temperature-controlled supply chain solutions for the life
sciences industry, today announced financial results for the
three-month period ended March 31, 2021.
Jerrell Shelton, CEO of Cryoport,
said, "It was a strong quarter and it developed as we had
anticipated. We entered 2021 with an unrivaled leadership position
with market-leading temperature-controlled supply chain solutions
for the life sciences industry in our markets of Biopharma/Pharma,
Animal Health and Reproductive Medicine. Our global platform,
consisting of 32 locations and a family of companies that provide
mutually reinforcing solutions, services and products, delivered an
outstanding performance. Cryoport's revenue grew to a record
$53.3 million for the quarter with
our recent acquisitions of MVE Biological Solutions and CRYOPDP
contributing significantly as we navigated the ongoing integration
of these two fine acquisitions. I would like to emphasize that all
our business units reported record revenue as well as strong
sequential growth over our record fourth quarter 2020. This
performance was primarily driven by the Biopharma/Pharma market,
which represented approximately 80% of our total revenue in the
first quarter of 2021. It is notable that we continued to build out
our pipeline of potential commercial customers with the total
number of regenerative medicine clinical trials
supported by Cryoport reaching a record 543 trials compared
with 465 at the end of the first quarter of 2020 as well as adding
2 new commercial launches supported by Cryoport.
"Since closing our two strategic acquisitions, MVE Biological
Solutions and CRYOPDP, we have sharpened each company's focus and
made investments in the businesses to fuel their growth, which we
believe positions us for excellent growth in 2021 and beyond. Prior
to being acquired by Cryoport, both businesses were parts of very
large companies and were not focused on Cryoport's high-growth
regenerative medicine market. In the short time since closing these
acquisitions, we have made significant strides in defining
strategic focus, aligning resources, identifying synergies and
stoking the innovation pipeline of each business. One example is
the recent joint launch of our new global logistics center in
Osaka, Japan which will further
accelerate growth in APAC. As I have previously expressed, we
anticipate achieving over $100
million of revenue and cost synergies over a 5-year period
from CRYOPDP and Cryoport Systems, and the process of identifying
and executing on these synergies is on schedule.
"At MVE Biological Solutions, our factories are now running at
record production levels, as they benefit from a newly invigorated
strategic direction. Revenue growth rates for both MVE Biological
Solutions and CRYOPDP were significantly higher than their
historical growth rates and we believe these first two quarters, as
a part of Cryoport, are an early indicator of the growth potential
these two businesses have. We anticipate continued strength from
both MVE Biological Solutions and CRYOPDP throughout 2021 as they
further integrate into Cryoport. Our organic revenue, which
excludes contributions from MVE Biological Solutions and CRYOPDP,
increased by 35% year over year as we continue to support the ramp
of clinical trials and commercial therapies. Through our dedicated
teams, ongoing investments and expanded footprint, we now have a
very broad reach within the industry and are dedicated to
continuously scaling our business with focus and purpose.
"Our first quarter 2021 revenue as compared to first quarter
2020 was as follows:
Cryoport, Inc. and
Subsidiaries
|
Total revenues by
market
|
(unaudited)
|
|
Three Months
Ended
March 31,
|
|
(in
thousands)
|
2021
|
2020
|
%
Change
|
Biopharma/Pharma
|
$
42,393
|
$
8,786
|
382.5%
|
Animal
Health
|
8,997
|
225
|
3893.1%
|
Reproductive
Medicine
|
1,894
|
763
|
148.4%
|
Total
revenues
|
$
53,284
|
$
9,774
|
445.2%
|
"In summary, our first quarter of 2021 was a very successful
start to the year, following an already strong fourth quarter in
2020. We achieved significant growth in all our operating units
with a growing number of clinical trials supported, the scaling of
MVE Biological Solutions and CRYOPDP, and the closing of a
$287.5 million follow-on public
offering in January 2021 to further
strengthen our balance sheet and support future growth. We believe
our unique global capabilities widen our competitive moat and
position us to extend our support of the life sciences industry and
the clinical and commercial stage regenerative medicine therapies
around the world. We plan to accelerate growth in each of our
operating units as we further enhance our operating platform and
develop highly differentiated and specialized solutions," said Mr.
Shelton.
Biopharma/Pharma
Total Biopharma/Pharma revenue increased by $33.6 million, or 383%, to $42.4 million for the first quarter of 2021
compared to $8.8 million for the
first quarter of 2020, driven by record revenue contribution from
all business units. For the first quarter of 2021, Biopharma/Pharma
revenue grew organically (excluding contributions from MVE
Biological Solutions and CRYOPDP) by $2.8
million, or 32%, to $11.6
million compared to the first quarter in the prior year.
During the quarter, we extended our leading position in the
Biopharma/Pharma market with continued growth in net clinical
trials. As the global emergence of regenerative therapies continues
and new trials are launched, we believe that our enhanced global
platform for temperature-controlled supply chain solutions
supporting the life sciences further makes us the clear choice to
support biopharmaceutical/pharmaceutical companies in bringing
their regenerative medicine therapies to market. As of the end of
the first quarter, we
supported a net total of 543 clinical
trials, compared with 465 at the end of the first quarter 2020 and
528 clinical trials as of December 31, 2020.
The number of trials by phase and region are as follows:
Cryoport Supported
Clinical Trials by Phase
|
|
Clinical
Trials
|
Q1
2021
|
Q1
2020
|
Q12019
|
Phase 1
|
222
|
195
|
155
|
Phase 2
|
252
|
208
|
179
|
Phase 3
|
69
|
62
|
49
|
Total
|
543
|
465
|
383
|
|
|
|
|
|
|
|
|
Cryoport Supported
Clinical Trials by Region
|
|
Region
|
Q1
2021
|
Q1
2020
|
Q1
2019
|
Americas
|
429
|
384
|
338
|
EMEA
|
86
|
65
|
45
|
APAC
|
28
|
16
|
0
|
Total
|
543
|
465
|
383
|
We continued to work closely with all our partners and clients
to ensure patients have access to the life-saving therapies we
support. Commercial revenue, to date, has been primarily the result
of our global agreements supporting the ramp ups of Novartis's
KYMRIAH® and Gilead/Kite's YESCARTA®.
In addition, Bristol-Myers Squibb (BMS) has received US
Food and Drug Administration (FDA)
approval for its cell therapy BREYANZI®, and
bluebird bio and BMS and have received FDA approval for their CAR
T-cell therapy Abecma®, a first-of-its-kind CAR T-cell
therapy for treatment of multiple myeloma. Cryoport will support
both these groundbreaking therapies,
marking Cryoport's sixth and seventh long-term
agreements supporting the global commercial launch of a cell and
gene therapy. We expect these agreements to contribute to our
revenue in the second quarter of 2021 and will begin to ramp
throughout 2021, driving additional growth in our commercial
revenue in 2021.
In addition to our organic growth, and due to increasing demand
for support in the APAC region, we acquired Critical Transport
Solutions Australia Pty Ltd ("CTSA") in April of this year, a
market leader focused on premium healthcare logistics management
services, specializing in time- and temperature-critical solutions
for the medical and biopharma/pharma industries in Australia. As a part of Cryoport's CRYOPDP
business unit, CTSA will also support Cryoport Systems in
Australia. CTSA is expected to
have strategic impact on our APAC initiatives as the number of
clinical trials taking place in this region continues to increase
and the acquisition of CTSA is an important step in advancing our
APAC strategy. With the addition of CTSA, we can now serve the
domestic Australian market more effectively, as well as providing
more robust temperature-controlled supply chain solutions for our
international clients, who require support in the APAC region.
A total of three (3) Cryoport supported Marketing Authorization
Applications (MAAs) or Biologic License Applications (BLAs) were
filed in the first quarter of 2021, based on internal information
and forecasts from the Alliance for Regenerative Medicine. Looking
forward, we anticipate up to 18 MAA or BLA submissions for
Cryoport-supported products during 2021.
COVID-19 pandemic support is not our focus within the
Biopharma/Pharma market; however, Cryoport does support 33 clinical
trials of COVID-19-related vaccines and treatments globally and one
commercial treatment for patients that have COVID-19 across its
business units as of the end of the first quarter of 2021. Our key
focus continues to be the rapidly growing cell and gene therapy
market. COVID-19 pandemic support agreements only contributed
marginally to our strong revenue growth for the quarter, and we do
not anticipate these products to be a significant revenue driver
going forward.
Animal Health
Our revenue from the Animal Health market increased by
$8.8 million, or 3,893%, to
$9.0 million for the first quarter
ended March 31, 2021, as compared to
the same period in 2020. This increase was driven primarily by our
acquisition of MVE Biological Solutions on October 1, 2020, which has a strong and
longstanding presence in this market. In addition, our overall
pipeline of potential new clients continues to grow and is expected
to further drive revenue growth in 2021.
Reproductive Medicine
Reproductive Medicine revenue increased by $1.1 million, or 148%, to $1.9 million for the first quarter of 2021
compared to $0.8 million for the
first quarter of 2020.
These results were partially driven by our
enhanced market engagement strategy for our
CryoStork®
solution as well as increased activity as fertility
clinics ramped up procedures that had previously been delayed due
to COVID-19. MVE Biological Solutions also contributed revenue to
our Reproductive Medicine market through its portfolio of cryogenic
shipper and freezer solutions. We plan to continue to add
fertility clinics to our network in 2021 to drive increased
adoption of our services as well as expand our support efforts
within this space to EMEA and APAC.
Financial Highlights
- Total revenue for the first quarter of 2021 increased to
$53.3 million compared to
$9.8 million for the first quarter of
2020, a year-over-year gain of 445%, with organic revenue growth
(excluding contributions from MVE Biological Solutions and CRYOPDP)
of 35%.
- Biopharma/Pharma revenue increased to $42.4 million, a gain of 383% or $33.6 million for the first quarter of 2021
compared to $8.8 million for the
first quarter of 2020.
- Animal Health revenue increased to $9.0 million, a gain of 3,893% or $8.8 million for the first quarter of 2021
compared to $0.2 million for the
first quarter of 2020.
- Reproductive Medicine revenue increased to $1.9 million, a gain of 148% or $1.1 million for the first quarter of 2021
compared to $0.8 million for the
first quarter of 2020.
- Gross margin was 46% for the first quarter of 2021 compared
to 54% for the first quarter of 2020. While the combined margin
profile has changed as a result of the acquisitions, gross margin
has increased significantly from 41% reported for the fourth
quarter of 2020, which was the first quarter of combined
performance.
- Operating costs and expenses increased by $16.8 million to $25.7
million for the first quarter of 2021 compared to
$8.8 million for the first quarter of
2020. The first quarter of 2021 includes $10.6 million in operating costs and expenses
related to MVE Biological Solutions and CRYOPDP, both acquired
October 1, 2020. The remaining
increase in operating costs and expenses of $6.2 million is related to the further build out
of our competencies, infrastructure, and technology development to
support the continuing scaling of our business and demand for
Cryoport's solutions.
- Net loss for the first quarter of 2021 was $3.5 million compared to a net loss of
$3.9 million for the first quarter of
2020.
- Net loss attributable to common stockholders was
$5.7 million, or $0.13 per share, for the first quarter of 2021
compared to a net loss attributable to common stockholders of
$3.9 million, or $0.11 per share, for the first quarter of 2020.
This was driven by a paid-in-kind dividend of $2.2 million during the first quarter of 2021
resulting from the private placement of Series C Preferred Stock
with Blackstone, completed in connection with the MVE Biological
Solutions acquisition.
- Adjusted EBITDA for the first quarter of 2021 was
$7.0 million compared to
($1.8 million) for the first quarter
of 2020, an increase of $8.8 million
over the prior year first quarter. This increase was primarily
driven by the strong performance and resulting contribution of MVE
Biological Solutions for the quarter.
- Cryoport reported $353.2
million in cash, cash equivalents and short-term investments
as of March 31, 2021, compared with
$93.3 million as of December 31, 2020. This amount includes net
proceeds of approximately $269.8
million received from an underwritten public offering of
4,356,059 shares of its common stock, at a public offering price of
$66.00 per share, during the first
quarter of 2021.
- In February 2021, Blackstone
converted an aggregate of 50,000 shares of the Company's Series C
Preferred Stock and received in exchange an aggregate of 1,312,860
shares of common stock.
Note:
All reconciliations of GAAP to adjusted (non-GAAP)
figures above are detailed in the reconciliation tables included
later in the press release.
Further information on Cryoport's financial results is included
on the attached condensed consolidated balance sheets and
statements of operations, and additional explanations of Cryoport's
financial performance are provided in Cryoport's quarterly report
on Form 10-Q for the three months ended March 31, 2021, which is expected to be filed
with the Securities and Exchange Commission ("SEC") on May 6, 2021. The full report will be available on
the SEC Filings section of the Investor Relations section of
Cryoport's website at www.cryoport.com.
Earnings Conference Call Information
IMPORTANT INFORMATION: A document titled "Cryoport First
Quarter 2021 In Review", providing a review of Cryoport's recent
financial and operational performance and a general business
update, will be issued at 4:05 pm EDT on
Tuesday, May 4, 2021. The document is designed to be read by
investors before the questions and answers conference call and will
be accessible at
http://ir.cryoport.com/events-and-presentations.
Cryoport management will host a conference call at 5:00 pm EDT on Tuesday, May 4, 2021.
The conference call will be in the format of a questions and answers session and will address any
queries investors have regarding the Company's
reported results.
Conference Call Information
Date:
|
May 4,
2021
|
Time:
|
5:00 p.m.
EDT
|
Dial-in
numbers:
|
1-855-327-6837
(U.S.), 1-631-891-4304 (International)
|
Confirmation
code:
|
Request the "Cryoport
Call"
|
Live
webcast:
|
'Investor Relations'
section at www.cryoport.com or at this link. Please allow 10
minutes prior to the call to visit this site to download and
install any necessary audio software.
|
Questions and answers will be recorded and available approximately three hours after completion
of the live event on the Investor Relations section of the Company's website at www.cryoport.com for
a limited time. To access the replay of the questions and answers,
please follow this link. A dial-in replay of the call will also be
available, to those interested, until May
11, 2021. To access the replay, dial +1 844-512-2921
(United States) or +1 412-317-6671
(International) and enter replay pin number: 10014267.
About Cryoport, Inc.
Cryoport, Inc. (Nasdaq: CYRX) is redefining
temperature-controlled supply chain support for the life sciences
industry by continually broadening its platform of solutions and
services, serving the Biopharma/Pharma, Animal Health, and
Reproductive Medicine markets. Through its family of companies,
Cryoport Systems, MVE Biological Solutions, CRYOPDP and CRYOGENE,
Cryoport provides strategic solutions that support the growing
needs of these markets.
Forward-Looking Statements
Statements in this press release which are not purely
historical, including statements regarding the Company's
intentions, hopes, beliefs, expectations, representations,
projections, plans or predictions of the future, are
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements include, but are not limited to, those related to the
Company's industry, business, plans, strategy, acquisitions,
including CRYOPDP and MVE Biological Solutions, financial results
and financial condition. It is important to note that the
Company's actual results could differ materially from those in any
such forward-looking statements. Factors that could cause actual
results to differ materially include, but are not limited to, risks
and uncertainties associated with the effect of changing economic
conditions, trends in the products markets, variations in the
Company's cash flow, market acceptance risks, and technical
development risks. The Company's business could be affected by a
number of other factors, including the risk factors discussed in
the Company's Securities and Exchange Commission ("SEC") reports
including, but not limited to, the Company's Annual Report on Form
10-K for the year ended December 31,
2020 and any subsequent filings with the SEC. The
forward-looking statements contained in this press release speak
only as of the date hereof and the Company cautions investors not
to place undue reliance on these forward-looking statements. Except
as required by law, the Company disclaims any obligation, and does
not undertake to update or revise any forward-looking statements in
this press release.
Cryoport, Inc. and
Subsidiaries
|
Condensed
Consolidated Statements of Operations
|
(unaudited)
|
|
Three Months
Ended
March 31,
|
(in thousands,
except share and per share data)
|
2021
|
2020
|
Revenues:
|
|
|
Service
revenues
|
$
26,765
|
$
9,774
|
Product
revenues
|
26,519
|
-
|
Total
revenues
|
53,284
|
9,774
|
Cost of
revenues:
|
|
|
Cost of service
revenues
|
15,552
|
4,516
|
Cost of product
revenues
|
13,182
|
-
|
Total cost of
revenues
|
28,734
|
4,516
|
Gross
Margin
|
24,550
|
5,258
|
Operating costs
and expenses:
|
|
|
Selling, general and
administrative
|
21,388
|
7,111
|
Engineering and
development
|
4,304
|
1,733
|
Total operating
costs and expenses:
|
25,692
|
8,844
|
Loss from
operations
|
(1,142)
|
(3,586)
|
Other income
(expense):
|
|
|
Investment
income
|
398
|
307
|
Interest
expense
|
(1,210)
|
(2)
|
Other expense,
net
|
(535)
|
(628)
|
Loss before provision
for income taxes
|
(2,489)
|
(3,909)
|
Provision for income
taxes
|
(1,038)
|
(33)
|
Net
loss
|
$
(3,527)
|
$
(3,942)
|
Paid-in-kind dividend
on Series C convertible preferred stock
|
(2,196)
|
-
|
Net loss
attributable to common stockholders
|
$
(5,723)
|
$
(3,942)
|
Net loss per share
attributable to common stockholders - basic and
diluted
|
$
(0.13)
|
$
(0.11)
|
Weighted average
common shares outstanding - basic and diluted
|
43,804,483
|
37,548,549
|
Cryoport, Inc. and
Subsidiaries
|
Condensed
Consolidated Balance Sheets
|
|
March
31,
|
December
31,
|
|
2021
|
2020
|
(in
thousands)
|
(unaudited)
|
|
Current
assets:
|
|
|
Cash and
cash equivalents
|
$
85,494
|
$
36,873
|
Short-term investments
|
267,721
|
56,444
|
Accounts
receivable, net
|
36,504
|
31,377
|
Inventories
|
11,544
|
10,535
|
Prepaid
expense and other current assets
|
18,485
|
11,928
|
Total
current assets
|
419,748
|
147,157
|
Property
and equipment, net
|
31,694
|
30,036
|
Operating lease right-of-use assets
|
15,996
|
14,044
|
Intangible assets, net
|
209,267
|
213,908
|
Goodwill
|
141,305
|
145,282
|
Deposits
|
946
|
1,184
|
Other
long-term assets
|
752
|
794
|
Total
assets
|
$
819,708
|
$
552,405
|
|
|
|
Current
liabilities:
|
|
|
Accounts
payable and other accrued expenses
|
$
27,083
|
$
24,844
|
Accrued
compensation and related expenses
|
8,233
|
7,441
|
Deferred
revenue
|
495
|
445
|
Operating
lease liabilities
|
2,002
|
2,231
|
Finance lease
liabilities
|
60
|
59
|
Total current
liabilites
|
37,873
|
35,020
|
Convertible
senior notes, net
|
111,536
|
111,344
|
Note
payable
|
3,497
|
4,912
|
Operating lease
liabilities, net
|
14,502
|
12,261
|
Finance lease
liabilities, net
|
92
|
112
|
Deferred tax
liability
|
4,626
|
5,882
|
Other long-term
liabilities
|
307
|
176
|
Total liabilities
|
172,433
|
169,707
|
Total stockholders' equity
|
647,275
|
382,698
|
Total liabilities and stockholders' equity
|
$
819,708
|
$
552,405
|
Note Regarding Use of Non-GAAP Financial Measures
This news release contains the following non-GAAP financial
measures as defined in Regulation G of the Securities Exchange Act
of 1934: adjusted EBITDA, organic revenue, and organic revenue
growth.
Adjusted EBITDA is defined as net loss adjusted for interest
expense, income taxes, depreciation and amortization expense,
stock-based compensation expense, acquisition and integration
costs, investment income, and charges or gains resulting from
non-recurring events.
Organic revenue is a change in revenue adjusted for acquisitions
of businesses that have been owned for less than twelve months. To
present period-over-period organic revenues on a comparable basis,
revenues are adjusted to include only revenues from those
businesses and assets owned during both periods. Accordingly,
organic revenue excludes from the current period, revenues
attributable to each acquisition for twelve months subsequent to
the day of acquisition, as there are no revenues from those
businesses and assets included in the comparable prior period.
Organic revenue growth refers to the measure of comparing
current period organic revenue with the corresponding period of the
prior year.
These non-GAAP financial measures are not calculated in
accordance with generally accepted accounting principles (GAAP),
are not based on any comprehensive set of accounting rules or
principles and may be different from non-GAAP financial measures
presented by other companies. Non-GAAP financial measures,
including adjusted EBITDA, organic revenue, and organic revenue
growth, should not be considered as a substitute for, or superior
to, measures of financial performance prepared in accordance with
GAAP.
In evaluating Cryoport's performance, management uses these
non-GAAP financial measures to supplement financial statements
prepared under GAAP. Management believes adjusted EBITDA provides a
useful measure of Cryoport's operating results, a meaningful
comparison with historical results and with the results of other
companies, and insight into Cryoport's ongoing operating
performance. Further, management and the Board of Directors utilize
adjusted EBITDA to gain a better understanding of Cryoport's
comparative operating performance from period-to-period and as a
basis for planning and forecasting future periods. Management
believes adjusted EBITDA, when read in conjunction with Cryoport's
GAAP financials, is useful to investors because they provide a
basis for meaningful period-to-period comparisons of Cryoport's
ongoing operating results, including results of operations, against
investor and analyst financial models, identifying trends in
Cryoport's underlying business and performing related trend
analyses, and they provide a better understanding of how management
plans and measures Cryoport's underlying business.
Additionally, management believes organic revenue and organic
revenue growth provide a useful measure to assess the performance
of Cryoport and its business units and reportable segments, without
the impact of recent acquisitions. Management believes organic
revenue and organic revenue growth, when read in conjunction with
Cryoport's GAAP financials, are useful to investors because they
provide a basis for meaningful period-to-period comparisons of
Cryoport's revenues.
Cryoport, Inc. and
Subsidiaries
|
Reconciliation of
GAAP net loss to adjusted EBITDA
|
(unaudited)
|
|
Three Months
Ended
March 31,
|
(in
thousands)
|
2021
|
2020
|
GAAP net
loss
|
$
(3,527)
|
$
(3,942)
|
Non-GAAP adjustments
to net loss:
|
|
|
Depreciation and amortization expense
|
4,837
|
824
|
Acquisition and integration costs
|
828
|
-
|
Investment income
|
(398)
|
(307)
|
Interest expense, net
|
1,210
|
2
|
Stock-based compensation expense
|
2,990
|
1,620
|
Income taxes
|
1,038
|
33
|
Adjusted
EBITDA
|
$
6,978
|
$
(1,770)
|
Cryoport, Inc. and
Subsidiaries
|
Organic revenue
growth (non-GAAP) by market
|
(unaudited)
|
Calculation of
Organic Revenue for the Three Months Ended
|
|
March 31,
2021
|
|
March 31,
2020
|
|
|
|
|
Revenue
|
|
Organic
|
|
Revenue
|
|
Organic
|
|
Change
in
|
|
as
|
|
Revenue
|
|
as
|
|
Revenue
|
|
Organic
Revenue
|
(in
thousands)
|
Reported
|
Acquisitions
|
(Non-GAAP)
|
|
Reported
|
Acquisitions
|
(Non-GAAP)
|
|
$
Change
|
%
Change
|
|
|
|
|
|
|
|
|
|
|
|
Biopharma/Pharma
|
$
42,393
|
$
30,784
|
$
11,609
|
|
$
8,786
|
$
-
|
$
8,786
|
|
$
2,823
|
32.1%
|
Animal
Health
|
8,997
|
8,729
|
268
|
|
225
|
-
|
225
|
|
43
|
18.9%
|
Reproductive
Medicine
|
1,894
|
545
|
1,349
|
|
763
|
-
|
763
|
|
586
|
76.9%
|
Total
revenues
|
$
53,284
|
$
40,058
|
$
13,226
|
|
$
9,774
|
$
-
|
$
9,774
|
|
$
3,452
|
35.3%
|
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multimedia:http://www.prnewswire.com/news-releases/cryoport-revenue-climbs-to-53-3-million-for-first-quarter-2021--301283733.html
SOURCE Cryoport, Inc.