NASHVILLE, Tenn., March 5, 2020 /PRNewswire/ -- Cryoport, Inc.
(NASDAQ: CYRX) (NASDAQ: CYRXW) ("Cryoport"), a global leader in
life sciences solutions, today announced financial results for the
three and twelve-month periods ended December 31, 2019.
"We reported revenue of $33.9
million for fiscal year 2019, an increase of 73% from fiscal
year 2018," said Jerrell Shelton,
Chief Executive Officer of Cryoport. "This record revenue was
driven partly by our commercial agreements supporting Gilead's
YESCARTA® and Novartis' KYMRIAH®, which
contributed $8.3 million in the
twelve-month period, an increase of 295% or $6.2 million, compared with the prior year.
Revenue from our commercial agreements is expected to continue
to grow throughout 2020 as the rollouts of these lifesaving
therapies accelerate. We also expect to start generating revenue
from the commercial launch of bluebird bio's ZYNTEGLO™, commencing
in the first quarter of 2020.
"Global Bioservices contributed $3.0
million in revenue for fiscal year 2019 as a result of the
Cryogene acquisition in May 2019. We
have made meaningful progress in leveraging cross-selling
opportunities and onboarded several Cryoport clients to the
Cryogene platform during the second half of 2019. We expect revenue
from existing clients and cross-selling opportunities to continue
to drive revenue growth throughout 2020.
Mr. Shelton continued, "As we deepen and broaden our Compliance
Unified Ecosystem™ of global strategic alliances to better
serve our life sciences markets we are also investing in
infrastructure, adding new talent to our teams, and developing new,
innovative solutions. This includes the build out of a larger
Global Supply Chain Center in Morris
Plains, New Jersey and a new Global Supply Chain Center in
Houston, Texas to provide global
logistics and bioservices solutions to meet the growing demands for
our services and to ensure we have the scale to serve an expanded
client base. Both centers are expected to be completed during the
fourth quarter of 2020."
"In 2019 the global regenerative medicine market experienced
significant growth, resulting in an expanding pipeline of
therapies. According to the Alliance for Regenerative Medicine,
there are currently a total of 1,066 clinical trials in the
Regenerative Medicine market, globally, with 381 trials in Phase I,
591 in Phase II, and 94 in Phase III. A record total of five
Cryoport supported Marketing Authorization Applications (MAA's) or
Biologics Licensing Applications (BLA's) were filed during the
fourth quarter of 2019. We expect this momentum to accelerate, with
approximately 10 additional Cryoport-supported MAA's and BLA's
filed in 2020, based on internal information and forecasts from the
Alliance for Regenerative Medicine. These filings are
anticipated to be primary revenue drivers for Cryoport in the
future as each of them requires comprehensive
temperature-controlled solutions support at scale.
"During the Fourth Quarter, we added a net total of 11 clinical
trials, bringing the grand total of regenerative therapy clinical
trials supported by Cryoport to a record 436, of which 56 are
currently in Phase III. We anticipate the continued expansion of
the Regenerative Medicine market, together with growth in
Cryoport's market share, to drive an ongoing and significant
increase in the number of clinical trials we support," continued
Mr. Shelton.
"The Reproductive Medicine market is solid and growing, with
2019 revenue growing 34% year over year driven by increased
adoption of our specialized solutions in domestic and international
markets. The Prelude Network, which is the largest network of
fertility centers in the U.S., will accelerate our growth in the
Reproductive Medicine market as it rolls out our platform of
temperature-controlled solutions to its entire clinical network and
its strong pipeline of prospects.
"Revenue from the Animal Health market increased 2% year over
year and is expected to accelerate in 2020 due to expansion of
services to our existing base and the development of new clients in
this area. We are confident in our strategies to grow our presence
in both the Reproductive Medicine and Animal Health markets in
2020."
"In Fiscal 2019 we secured several new client agreements and
top-tier partnerships and invested in new infrastructure build. As
a result, we have entered 2020 with a strong foundation, supported
by approximately $94 million in cash
and short-term investments, to further drive infrastructure build
out, organic growth and acquisitions. We will continue to advance
our strategy to build out our Compliance Unified Ecosystem™ ("CUE")
within the life sciences industry by expanding both our global
network and platform solutions. We believe the Regenerative
Medicine market will continue to accelerate as new life changing
therapies enter clinical trials and reach commercial approval. This
is a pivotal time in Cryoport's evolution, and we are laser-focused
on seizing this unique opportunity to build value for our
shareholders and bring life changing therapies to market," Mr.
Shelton concluded.
Market Highlights:
Global Logistics Solutions
Biopharma
- Biopharma revenue increased by 64% in the twelve months ended
December 31, 2019 compared to the
same period in 2018; for the quarter ended December 31, 2019, biopharma revenue increased
42% compared to the same period in 2018.
- Commercial revenue increased $6.2
million or 295% to $8.3
million for year ended December 31,
2019, as compared to $2.1
million for the same period in 2018; for the quarter ended
December 31, 2019, commercial revenue
increased $1.6 million or 200% to
$2.4 million, as compared to
$0.8 million for the same period in
2018.
- Cryoport is now supporting a net total of 436 clinical trials
as of December 31, 2019 compared with
357 as of December 31, 2018. The
number of trials in Phase III grew to 56, compared with 47 as of
December 31, 2018. Of the 436
total trials Cryoport supports, 361 are in the Americas, 61 in EMEA
(Europe, the Middle East and Africa) and 14 in APAC (Asia Pacific). This compares to 317 in the
Americas and 40 in EMEA as of December 31,
2018.
- During 2019, Cryoport expanded its Compliance Unified
Ecosystem™ of global strategic alliances through previously
announced relationships with Lonza, Vineti, and EVERSANA to further
expand its leadership position in the markets.
Animal Health
- Animal Health revenue increased by 2% in the twelve months
ended December 31, 2019 compared to
the same period in 2018; for the quarter ended December 31, 2019, Animal Health revenue
increased 28% compared to the same period in 2018.
- Cryoport is growing its revenue in the Animal Health market
through new dedicated resources. It has a strong pipeline of
potential clients, which is anticipated to drive revenue growth in
2020.
Reproductive Medicine
- Reproductive Medicine revenue increased by 34% for the twelve
months ended December 31, 2019
compared to the same period in 2018; for the quarter ended
December 31, 2019 Reproductive
Medicine revenue increased by 23%, growing both domestically as
well as internationally. This growth can be attributed to
increasing awareness of our CryostorkTM platform as well
as maturing commercial relationships with large clinical
networks.
Global Bioservices
- Bioservices revenue was $1.3
million and $3.0 million for
the three and twelve-month periods ended December 31, 2019 resulting from the acquisition
of Cryogene consummated in May
2019.
Financial Highlights:
- Revenue increased 73% to $33.9
million and 62% to $9.2
million for the twelve and three-month periods ended
December 31, 2019, compared with the
same periods in the prior year.
- Excluding revenue from the Cryogene acquisition, consummated in
May of 2019, for the three and twelve-month periods ended
December 31, 2019, revenue grew 40%
and 58%, compared with the same periods in the prior year.
- Gross margin for the three and twelve-months ended December 31, 2019 was 53% and 51%, respectively,
compared to 50% and 52% for the respective periods in the prior
year.
- The 2019 financial results include a one-time charge of
$9.6 million in accelerated
stock-based compensation expense (non-cash) of which $0.4 million and $9.2
million are included in cost of revenues and operating costs
and expenses, respectively. The charge recorded in the third
quarter of 2019 incorrectly included stock option grants to
nonemployee directors which was reversed in the fourth quarter
resulting in a reduction of $0.8
million of stock-based compensation expense in the fourth
quarter of 2019.
- Operating costs and expenses increased by $0.8 million, and $16.1
million, for the three and twelve-month periods ended
December 31, 2019, respectively,
compared to the same periods in the prior year, as a result of
$9.6 million in one-time accelerated
stock-based compensation expenses (non-cash) as well as continued
investments in the build out of infrastructure to support the
accelerating market demands.
- Adjusted EBITDA for the three-month period ended December 31, 2019 was $0.8
million, compared with ($0.4
million) in the same three-month period in the prior year.
Adjusted EBITDA for the twelve-month period ended December 31, 2019, was $2.0 million, compared with ($2.2 million) in the same twelve-month period in
the prior year.
- Net loss for the three-month period ended December 31, 2019 was $0.9
million, or $0.03 per share
(Adjusted net loss was $1.7 million,
or $0.05 per share, excluding the
reversal of accelerated stock-based compensation expense for
nonemployee directors described above), compared to a net loss of
$2.3 million, or $0.08 per share in the same three-month period in
2018.
- Net loss for the twelve-month period ended December 31, 2019 was $18.3 million, or $0.55 per share (Adjusted net loss was $8.8
million, or $0.26 per share, excluding the accelerated
vesting stock-based compensation expense described above), compared
with $9.6 million, or $0.34 per share, in the same twelve-month period
in 2018.
- Cryoport reported $94.3 million
in cash, cash equivalents and short-term investments as of
December 31, 2019, compared with
$47.3 million as of December 31, 2018. This increase includes net
proceeds of $68.8 million received
from a public offering completed in June
2019.
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 annual report on
Form 10-K for the twelve months ended December 31, 2019, which will be filed with the
Securities and Exchange Commission ("SEC") on March 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 2019
Year in Review", which will provide a review of Cryoport's recent
financial and operational performance and a general business
update, will be issued by management at 4:05
pm ET on Thursday, March 5. 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 March 5,
2020. The conference call will be in the format of a
questions and answers session and will address any queries
investors have regarding Cryoport's reported results.
Conference Call Information
Date:
|
March 5,
2020
|
Time:
|
5:00 p.m.
ET
|
Dial-in
numbers:
|
+1 (855) 327-6837
(U.S.) or +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.
|
An archive of the question and answer webcast will be available
approximately three hours after completion of the live event and
will be accessible on the Investor Relations section of the
Company's website at www.cryoport.com for a limited time. To
access the replay of the webcast, please follow this link. A
dial-in replay of the call will also be available to those
interested until March 12, 2020. To
access the replay, dial +1 (844) 512-2921 (United States) or +1 (412) 317-6671
(International) and enter replay pin number: 10008682.
About Cryoport, Inc.
Cryoport, Inc. (Nasdaq: CYRX) is redefining logistics by
providing a platform of temperature-controlled solutions for the
life sciences industry, 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 through our advanced
technologies, Global Supply Chain Network and dedicated scientists,
technicians and supporting team of professionals. Through
purpose-built proprietary packaging; information technology; smart,
sustainable cold chain logistics; and biostorage/biobanking
services, Cryoport helps its customers advance life sciences
research, support life-saving advanced therapies and deliver
vaccines, protein producing materials, and IVF treatments 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, Inc.'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. 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 listed from time to time in the Company's SEC
reports including, but not limited to, the Company's 10-K for the
year ended December 31, 2019 filed
with the SEC. The Company cautions investors not to place undue
reliance on the forward-looking statements contained in this press
release. Cryoport, Inc. 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
|
|
|
|
|
|
|
|
Three Months
Ended
December 31,
|
|
Year Ended
December 31,
|
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
(unaudited)
|
|
(unaudited)
|
|
|
|
|
Revenues
|
|
$
9,242,066
|
|
$
5,690,898
|
|
$
33,941,900
|
|
$
19,626,453
|
Cost of
revenues
|
4,309,757
|
|
2,874,710
|
|
16,590,244
|
|
9,386,188
|
Gross
margin
|
4,932,309
|
|
2,816,188
|
|
17,351,656
|
|
10,240,265
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
|
General and
administrative
|
2,132,865
|
|
2,447,962
|
|
17,465,191
|
|
9,798,793
|
|
Sales and
marketing
|
2,608,210
|
|
1,989,330
|
|
13,820,868
|
|
7,245,644
|
|
Engineering and
development
|
1,069,585
|
|
598,761
|
|
3,740,642
|
|
1,840,443
|
Total operating costs
and expenses
|
5,810,660
|
|
5,036,053
|
|
35,026,701
|
|
18,884,880
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(878,351)
|
|
(2,219,865)
|
|
(17,675,045)
|
|
(8,644,615)
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Interest
expense
|
(445,876)
|
|
(69,253)
|
|
(1,366,924)
|
|
(69,253)
|
|
Warrant inducement
and repricing expense
|
-
|
|
-
|
|
-
|
|
(899,410)
|
|
Other income,
net
|
427,653
|
|
35,068
|
|
772,065
|
|
77,631
|
Loss before provision
for income taxes
|
(896,574)
|
|
(2,254,050)
|
|
(18,269,904)
|
|
(9,535,647)
|
Provision for income
taxes
|
(50,965)
|
|
(4,214)
|
|
(61,575)
|
|
(19,954)
|
Net loss
|
|
(947,539)
|
|
(2,258,264)
|
|
(18,331,479)
|
|
(9,555,601)
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share - basic and diluted
|
$
(0.03)
|
|
$
(0.08)
|
|
$
(0.55)
|
|
$
(0.34)
|
Weighted average
shares outstanding - basic and diluted
|
36,196,524
|
|
29,454,077
|
|
33,394,285
|
|
28,210,648
|
Cryoport Inc. and
Subsidiaries
|
Condensed
Consolidated Balance Sheets
|
|
|
|
|
December
31,
|
|
|
|
2019
|
|
2018
|
Current
Assets:
|
|
|
|
|
Cash and cash
equivalents
|
$
47,234,770
|
|
$
37,327,125
|
|
Short-term
investments
|
47,060,786
|
|
9,930,968
|
|
Accounts receivable,
net
|
7,098,191
|
|
3,543,666
|
|
Inventories
|
473,961
|
|
220,514
|
|
Prepaid expenses and
other current assets
|
1,096,855
|
|
752,269
|
|
|
Total current
assets
|
102,964,563
|
|
51,774,542
|
Property and
equipment, net
|
11,833,057
|
|
4,357,498
|
Operating lease
right-of-use assets
|
4,460,319
|
|
-
|
Intangible assets,
net
|
5,177,578
|
|
137,220
|
Goodwill
|
|
10,999,722
|
|
-
|
Deposits
|
|
437,299
|
|
350,837
|
|
|
Total
assets
|
$
135,872,538
|
|
$
56,620,097
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable and
other accrued expenses
|
$
2,498,375
|
|
$
1,709,397
|
|
Accrued compensation
and related expenses
|
1,903,720
|
|
1,262,478
|
|
Deferred
revenue
|
367,867
|
|
66,315
|
|
Operating lease
liabilities
|
665,901
|
|
|
|
Finance lease
liabilities
|
24,617
|
|
23,191
|
|
|
Total current
liabilities
|
5,460,480
|
|
3,061,381
|
|
Convertible note,
net
|
-
|
|
14,711,580
|
|
Operating lease
liabilities, net
|
4,101,236
|
|
-
|
|
Finance lease
liabilities, net
|
8,539
|
|
33,156
|
|
Deferred rent
liability, net
|
-
|
|
267,415
|
|
Deferred tax
liability
|
20,935
|
|
-
|
|
|
Total
liabilities
|
9,591,190
|
|
18,073,532
|
|
|
Total stockholders'
equity
|
126,281,348
|
|
38,546,565
|
|
|
Total liabilities and
stockholders' equity
|
$
135,872,538
|
|
$
56,620,097
|
Note Regarding Use of Non-GAAP Financial Measures
This news release contains non-GAAP financial measures as defined
in Regulation G of the Securities Exchange Act of 1934. These
financial measures are not calculated in accordance with generally
accepted accounting principles (GAAP) and are 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 measures,
adjusted net loss and adjusted EBITDA, provide 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 these non-GAAP
financial measures 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 these non-GAAP financial measures, 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 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
Subsidiary
|
Adjusted EBITDA
Reconciliation
|
(unaudited)
|
|
|
|
|
Three Months
Ended
December 31,
|
|
Year Ended
December 31,
|
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
GAAP net
loss
|
$
(947,539)
|
|
$
(2,258,264)
|
|
$
(18,331,479)
|
|
$
(9,555,601)
|
|
Non-GAAP adjustments
to net loss:
|
|
|
|
|
|
|
|
|
|
Depreciation and
amortization expense
|
825,051
|
|
264,746
|
|
2,415,222
|
|
857,939
|
|
|
Interest
expense
|
445,876
|
|
69,253
|
|
1,366,924
|
|
69,253
|
|
|
Stock-based
compensation expense
|
382,467
|
|
1,484,723
|
|
16,523,506
|
|
5,478,625
|
|
|
Warrant repricing
expense
|
-
|
|
-
|
|
-
|
|
899,410
|
|
|
Income
taxes
|
50,965
|
|
4,214
|
|
61,575
|
|
19,954
|
Adjusted
EBITDA
|
$
756,820
|
|
$
(435,328)
|
|
$
2,035,748
|
|
$
(2,230,420)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cryoport Inc. and
Subsidiaries
|
Adjusted Net Loss and
Net Loss per Share Reconciliation
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
December 31,
|
|
Year Ended
December 31,
|
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
GAAP net
loss
|
$
(947,539)
|
|
$
(2,258,264)
|
|
$
(18,331,479)
|
|
$
(9,555,601)
|
|
Accelerated vesting
stock-based compensation expense
|
(765,099)
|
|
-
|
|
9,561,884
|
|
-
|
Adjusted net
loss
|
$
(1,712,638)
|
|
$
(2,258,264)
|
|
$
(8,769,595)
|
|
$
(9,555,601)
|
|
|
|
|
|
|
|
|
|
|
Adjusted net loss per
share - basic and diluted
|
$
(0.05)
|
|
$
(0.08)
|
|
$
(0.26)
|
|
$
(0.34)
|
Weighted average
shares outstanding - basic and diluted
|
36,196,524
|
|
29,454,077
|
|
33,394,285
|
|
28,210,648
|
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SOURCE Cryoport, Inc.