NASHVILLE, Tenn., Aug. 6, 2020 /PRNewswire/ -- Cryoport, Inc.
(NASDAQ: CYRX) ("Cryoport"), a global leader in life sciences
supply chain solutions, today announced financial results for
Second Quarter and six-month period ended June 30, 2020.
"For the Second Quarter of 2020, we reported revenue of
$9.4 million, an increase of 11% from
the Second Quarter of 2019. This was largely driven by revenue from
our biopharma segment. We are pleased to have achieved these solid
results and to have provided advanced temperature-controlled supply
chain services to deliver high-value therapies to eligible patients
across our clinical and commercial portfolios globally and without
disruption," said Jerrell Shelton,
Chairman and Chief Executive Officer.
"Our Second Quarter results reflect the strength and resilience
of our company where we saw continued year-over-year growth despite
the challenging environment caused by the COVID-19 pandemic. Thanks
to the tireless work of our colleagues around the world, we
continue to successfully navigate the external realities, and we
remain focused on our mission of supporting life and health by
delivering reliable and comprehensive temperature-controlled supply
chain solutions for the life sciences through our innovation,
advanced technologies, and global supply chain network.
"We now support four (4) commercial cell and gene therapies:
KYMRIAH®, YESCARTA®, TECARTUS™ and
ZYNTEGLO® along with Lisocabtagene Maraleucel
(liso-cel), which was recently validated by the European Medicines
Agency ("EMA").
"Gilead's Kite renewed our agreement for temperature-controlled
supply chain support of their commercial and clinical therapies,
and we are in the final stages of renewing our agreement with
Novartis in support of its commercial and clinical therapies. Over
the past several years, Cryoport's advanced solutions have
supported both KYMRIAH® and YESCARTA® through
their respective clinical phases and subsequent respective
commercial rollouts. The continuance of these partnerships with
these pioneers in the regenerative medicine market is important as
each extends its life-saving therapies to greater and greater
patient populations, globally. We think that as the only company
with a proven and advanced integrated suite of proprietary
temperature-controlled supply chain solutions to support the global
high-volume distribution of these valuable therapies, Cryoport's
position is highly entrenched and we work hard every day to
maintain that position. These renewals together with the increasing
number of clinical trials we support demonstrate our leading
position, which we will continue to fortify as the number of cell
and gene therapy trials grow and commercial therapies come to
market.
"Also, during the second quarter, FedEx extended its agreement
with Cryoport Systems, a relationship that allows both companies to
continue to jointly deliver temperature-controlled solutions for
select clients in the Biopharma, Animal Health and Reproductive
Medicine markets. The continuation of this partnership is a
validation of Cryoport's innovative technologies and FedEx's
foresight and an indication of the life sciences industry's growing
demand for advanced temperature-controlled supply chain
solutions.
Biopharma
"We continue to grow our leading position in the biopharma
market and are happy to report strong biopharma clinical trial
growth for the second quarter as a net total of 26 clinical trials
were added, bringing the total number of clinical trials supported
by Cryoport to a record 491. And, on another positive note, of the
56 clinical trials suspended at the end of the first quarter due to
the COVID-19 pandemic, only 3 remain suspended as of the end of the
second quarter. None of the remaining trials, to Cryoport's
knowledge, have been terminated.
"Cryoport's market share leadership of temperature-controlled
life science solutions continues to grow stronger as our client
base expands and our competency in tailored information technology
extends our market lead. The Alliance for Regenerative Medicine
(ARM) reported that at the end of June there were 11 ongoing
clinical trials worldwide for the development of COVID-19
treatments utilizing regenerative medicine and advanced therapies,
and Cryoport supports eight of them. This area remains very
active globally as many companies with the help of regulatory
support are moving at a rapid pace in search for a cure.
Cryoport is committed to supporting these important programs as we
all seek an end to the global pandemic.
"In July 2020, another
Cryoport-supported therapy received FDA approval, bringing the
total number of commercial products supported by Cryoport to four,
and, in addition, one more was validated by the EMA, and entered
the EMA's centralized review process. A further six (6) Cryoport
supported Marketing Authorization Applications or Biologic License
Applications are expected to be filed in 2020 and two additional
commercial approvals are possible, based on internal information
and forecasts from ARM, although the timing of some of these may be
impacted by the COVID-19 pandemic and other factors."
Mr. Shelton continued, "We expect revenue from our agreement
with Gilead's Kite to increase following the recent FDA approval of
TECARTUS™, its chimeric antigen receptor (CAR) T-cell therapy for
the treatment of adult patients with relapsed or refractory mantle
cell lymphoma (MCL). We are also seeing an acceleration of other
Cryoport supported regenerative therapies approaching
commercialization with the recent validation of Bristol Myers
Squibb's Application for CAR T-Cell Therapy Lisocabtagene
Maraleucel (liso-cel) by the EMA.
"Cryoport now supports a net total of 491 clinical trials
as of June 30, 2020 compared to 413 as of June 30,
2019. The number of trials in Phase III grew to 66, compared to
52 as of June 30, 2019. Of the 491 total trials
Cryoport supports, 400 are in the Americas, 72 in EMEA
(Europe, the Middle East and Africa) and 19 in APAC (Asia Pacific). This compares to 353 in
the Americas, 53 in EMEA and 7 in APAC as of June 30,
2019. Our market leading share of clinical trials continues to
climb as according to ARM there were a total of 1,078 active
clinical trials globally at the end of the second quarter, with 394
in Phase I, 587 in Phase II and 97 in Phase III.
"Another sign of the strength and belief in the potential of
cell and gene therapies can be seen in the financial markets.
Despite the economic challenges and uncertainty presented by the
pandemic regenerative medicine companies raised approximately
$10.7B in financing in the first half
of 2020, a 120% increase from the first half of 2019.
"To meet upcoming customer demand, further strengthen our global
footprint and support capabilities, we are continuing to build out
our new Cryoport Express™ Global Supply Chain Network and our full
range of temperature-controlled supply chain solutions, which
include a full range of bioservices and life sciences
logistics support. Both new Supply Chain Centers in Morris Plains, NJ and Houston, TX should be online by the first
quarter of 2021. Additionally, we continue to build our global
alliance network as we recently announced a partnership with
Medipal Holdings, one of the leading pharma wholesalers and
distributors in Japan. This partnership helps us grow our
abilities in the APAC region.
"Cryogene, the life sciences industry's most trusted biostorage
facility specializing in the secure storage of biological
specimens, materials, and samples for research purposes,
contributed revenue of $1.3 million
for the second quarter. Its operations were minimally impacted by
the COVID-19 pandemic and we continue to plan the geographic
expansion of our bioservices offering both in the U.S. and
globally."
Animal Health
Mr. Shelton continued, "Animal Health revenue remained steady at
$0.2 million for the three months
ended June 30, 2020; however, we are
building a strong pipeline of potential new clients and expect to
grow Animal Health revenue in the second half of 2020."
Reproductive Medicine
"The Reproductive Medicine market was impacted by the temporary
closure of fertility clinics globally and, consequently,
contributed revenue of $0.6 million
in the second quarter of 2020; however, we have begun to see
restrictions lifted, leading to a significant ramp in Reproductive
Medicine revenue during the final month of the second quarter. We
were pleased to see our partnership with Inception Fertility
contribute to this revenue ramp and believe we are well-positioned,
globally, for growth in this important market."
Financial Highlights
- Revenue increased 11% to $9.4
million for the three-month period ended June 30, 2020, compared with the same period in
the prior year.
- Revenue increased 27% to $19.2
million for the six-month period ended June 30, 2020, compared with the same period in
the prior year.
- Excluding revenue from the Cryogene acquisition in May of 2019,
revenue grew 2.7% for the three-month period ended June 30, 2020, compared with the same period in
the prior year. Excluding revenue from the Cryogene acquisition in
May of 2019, revenue grew 14.2% for the six-month period ended
June 30, 2020, compared with the same
period in the prior year.
- Biopharma revenue increased by 4.7% in the three months ended
June 30, 2020 compared to the same
period in 2019.
- Commercial Biopharma revenue increased $0.7 million or 38%, to $2.6 million for the three months ended
June 30, 2020, as compared to
$1.9 million for the same period in
2019.
- Gross margin for the three and six months ended June 30, 2020 was 55% and 54% respectively,
compared to 51% and 52% for the same periods in the prior
year.
- Operating costs and expenses increased by $4.3 million for the three-month period ended
June 30, 2020, compared to the same
period in the prior year, as a result of strategic initiatives,
such as the continued investments in infrastructure buildout,
including software development, which will provide a platform for
continuing the scaling of our business; engineering initiatives,
which includes the development of revolutionary packaging and
monitoring and communications resources, the development of our
Cryoport Express™ Global Supply Chain Network, and the build out of
competencies in support of advancing our infrastructure and the
growth in demand for Cryoport's solutions.
- Net loss for the three-month period ended June 30, 2020 was $5.8
million, or $0.15 per share,
compared to a net loss of $2.5
million, or $0.08 per share in
the same period in 2019.
- Net loss for the six-month period ended June 30, 2020 was $9.7
million, or $0.26 per share,
compared with $4.9 million, or
$0.16 per share, in the same
six-month period in 2019.
- Adjusted EBITDA for the three-month period ended June 30, 2020 was ($2.5
million), compared with $0.2
million in the same period in the prior year. Adjusted
EBITDA for the six-month period ended June
30, 2020, was ($4.1 million),
compared with ($0.1 million) in the
same six-month period in the prior year.
- Cryoport reported $208.2 million
in cash, cash equivalents and short-term investments as of
June 30, 2020, compared with
$94.3 million as of December 31, 2019. This increase includes net
proceeds of approximately $111
million received from a convertible debt offering during the
three-month period ended June 30,
2020.
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 June
30, 2020, which will be filed with the Securities and
Exchange Commission ("SEC") on or about August 10, 2020. 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 Second
Quarter 2020 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 ET on Thursday, August 6, 2020. The document is
designed to be read by investors before the questions and answers
conference call and can be accessed at
http://ir.cryoport.com/events-and-presentations.
Cryoport management will host a conference call at 5:00 pm ET on August 6,
2020. 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:
|
August 6,
2020
|
|
|
Time:
|
5:00 p.m.
ET
|
|
|
Dial-in
numbers:
|
+1 (800) 496-4125
(U.S.), +1 (720) 452-9104 (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
August 13, 2020. To access the
replay, dial +1 (844) 512-2921 (United
States) or +1 (412) 317-6671 (International) and enter
replay pin number: 7980251.
About Cryoport, Inc.
Cryoport, Inc. (Nasdaq: CYRX) is redefining
temperature-controlled supply chain support for the life sciences
industry by providing a platform of temperature-controlled
solutions, serving the Biopharma, Reproductive Medicine, and Animal
Health markets. Our mission is to support life and health on
earth by providing reliable and comprehensive solutions for the
life sciences industry through our advanced technologies, Global
Supply Chain Network and dedicated scientists, technicians and
supporting team of professionals. Through its purpose-built,
proprietary Cryoport Express® Shippers;
Cryoportal® information technology; validated Global
Logistics Centers; smart and sustainable temperature-controlled
logistics; and biostorage/biobanking services, Cryoport serves
clients in life sciences research, clinical trials, and product
commercialization. We support life-saving advanced cell and gene
therapies and deliver vaccines, protein producing materials, and
IVF materials in over 100 countries around the world. For more
information, visit www.cryoport.com or follow @cryoport on Twitter
at www.twitter.com/cryoport for live updates.
Forward Looking Statements
Statements in this news release which are not purely
historical, including statements regarding Cryoport'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, statements concerning Cryoport's industry, business,
strategy, financial results and financial condition, client
regulatory approvals, and the anticipated impact of COVID-19 on
Cryoport's business and industry.
It is important to note that Cryoport's actual results could
differ materially from those in any such forward-looking
statements. Key factors that could cause actual results to differ
materially from those projected in the forward-looking statements
include, but are not limited to, risks and uncertainties associated
with the effect of changing economic conditions, trends in the
products markets, variations in Cryoport's cash flow, market
acceptance risks, technical development risks, and the duration and
severity of the COVID-19 pandemic and its effects on the Cryoport's
business operations, financial performance and results of
operations. Cryoport's business could be affected by a number of
other factors, including the risk factors listed from time to time
in Cryoport's SEC reports including, but not limited to, Cryoport's
10-K for the year ended December 31,
2019, Cryoport's Quarterly Report on Form 10-Q for the
quarter ended June 30, 2020 and any
subsequent filings with the SEC. Cryoport cautions investors not to
place undue reliance on the forward-looking statements contained in
this press release, which speak only as of the date of this press
release. Except as required by law, Cryoport disclaims any
obligation, and does not undertake, to update or revise any
forward-looking statements in this press release.
Cryoport, Inc. and
Subsidiaries
|
Consolidated
Statements of Operations
|
(unaudited)
|
|
|
|
Three Months
Ended
June 30,
|
|
Six Months
Ended
June 30,
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Revenues
|
$
9,389,006
|
|
$
8,463,588
|
|
$
19,163,081
|
|
$
15,116,500
|
Cost of
revenues
|
4,262,010
|
|
4,125,199
|
|
8,778,121
|
|
7,324,210
|
Gross
margin
|
5,126,996
|
|
4,338,389
|
|
10,384,960
|
|
7,792,290
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
|
General and
administrative
|
5,733,149
|
|
3,258,781
|
|
9,763,191
|
|
5,955,640
|
|
Sales and
marketing
|
3,292,845
|
|
2,843,073
|
|
6,374,272
|
|
5,251,065
|
|
Engineering and
development
|
1,946,443
|
|
540,933
|
|
3,679,169
|
|
1,030,529
|
Total operating costs
and expenses
|
10,972,437
|
|
6,642,787
|
|
19,816,632
|
|
12,237,234
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(5,845,441)
|
|
(2,304,398)
|
|
(9,431,672)
|
|
(4,444,944)
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Interest
expense
|
(398,256)
|
|
(333,910)
|
|
(400,707)
|
|
(672,638)
|
|
Other income,
net
|
490,784
|
|
119,441
|
|
169,598
|
|
210,913
|
Loss before provision
for income taxes
|
(5,752,913)
|
|
(2,518,867)
|
|
(9,662,781)
|
|
(4,906,669)
|
Provision for income
taxes
|
(49,833)
|
|
(9,624)
|
|
(82,858)
|
|
(8,724)
|
Net
loss
|
$
(5,802,746)
|
|
$
(2,528,491)
|
|
$
(9,745,639)
|
|
$
(4,915,393)
|
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted
|
$
(0.15)
|
|
$
(0.08)
|
|
$
(0.26)
|
|
$
(0.16)
|
Weighted average
shares outstanding - basic and diluted
|
38,281,087
|
|
31,176,166
|
|
37,914,818
|
|
30,811,109
|
Cryoport, Inc. and
Subsidiaries
|
Condensed
Consolidated Balance Sheets
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
December
31,
|
|
|
|
2020
|
|
2019
|
|
|
|
(unaudited)
|
|
|
Current
Assets:
|
|
|
|
|
Cash and cash
equivalents
|
$
44,326,038
|
|
$
47,234,770
|
|
Short-term
investments
|
163,891,831
|
|
47,060,786
|
|
Accounts receivable,
net
|
7,038,733
|
|
7,098,191
|
|
Inventories
|
538,376
|
|
473,961
|
|
Prepaid expenses and
other current assets
|
891,652
|
|
1,096,855
|
|
|
Total current
assets
|
216,686,630
|
|
102,964,563
|
Property and
equipment, net
|
13,702,732
|
|
11,833,057
|
Operating lease
right-of-use assets
|
5,868,513
|
|
4,460,319
|
Intangible assets,
net
|
4,984,012
|
|
5,177,578
|
Goodwill
|
|
10,999,722
|
|
10,999,722
|
Deposits
|
|
534,978
|
|
437,299
|
|
|
Total
assets
|
$
252,776,587
|
|
$
135,872,538
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable and
other accrued expenses
|
$
6,509,745
|
|
$
2,498,375
|
|
Accrued compensation
and related expenses
|
1,852,186
|
|
1,903,720
|
|
Deferred
revenue
|
330,272
|
|
367,867
|
|
Operating lease
liabilities
|
691,386
|
|
665,901
|
|
Finance lease
liabilities
|
57,946
|
|
24,617
|
|
|
Total current
liabilities
|
9,441,535
|
|
5,460,480
|
|
Convertible senior
notes, net
|
110,977,419
|
|
-
|
|
Operating lease
liabilities, net
|
5,497,430
|
|
4,101,236
|
|
Finance lease
liabilities, net
|
146,570
|
|
8,539
|
|
Deferred tax
liability
|
56,945
|
|
20,935
|
|
|
Total
liabilities
|
126,119,899
|
|
9,591,190
|
|
|
Total stockholders'
equity
|
126,656,688
|
|
126,281,348
|
|
|
Total liabilities and
stockholders' equity
|
$
252,776,587
|
|
$
135,872,538
|
Note Regarding Use of Non-GAAP Financial Measures
This news release contains a non-GAAP financial measure as
defined in Regulation G of the Securities Exchange Act of
1934. This financial measure is not calculated in accordance
with generally accepted accounting principles (GAAP) and is not
based on any comprehensive set of accounting rules or principles.
In evaluating Cryoport's performance, management uses certain
non-GAAP financial measures to supplement financial statements
prepared under GAAP. Management believes that the following
non-GAAP financial measure, 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 this non-GAAP
financial measure 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 this non-GAAP financial measure, 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.
Cryoport, Inc. and
Subsidiaries
|
Adjusted EBITDA
Reconciliation
|
(unaudited)
|
|
|
|
|
Three Months
Ended
June 30,
|
|
Six Months
Ended
June 30,
|
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
GAAP net
loss
|
$
(5,802,746)
|
|
$
(2,528,491)
|
|
$
(9,745,639)
|
|
$
(4,915,393)
|
|
Non-GAAP adjustments
to net loss:
|
|
|
|
|
|
|
|
|
|
Depreciation and
amortization expense
|
844,281
|
|
496,690
|
|
1,668,710
|
|
797,255
|
|
|
Interest expense,
net
|
144,558
|
|
260,648
|
|
(51,626)
|
|
563,701
|
|
|
Stock-based
compensation expense
|
2,301,497
|
|
1,991,755
|
|
3,921,875
|
|
3,405,490
|
|
|
Income
taxes
|
49,833
|
|
9,624
|
|
82,858
|
|
8,724
|
Adjusted
EBITDA
|
$
(2,462,577)
|
|
$
230,226
|
|
$
(4,123,822)
|
|
$
(140,223)
|
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SOURCE Cryoport, Inc.