IRVINE, Calif., Aug. 8, 2019 /PRNewswire/ -- Cryoport, Inc.
(NASDAQ: CYRX) (NASDAQ: CYRXW) ("Cryoport"), the world's leading
temperature-controlled logistics company dedicated to the life
sciences industry, today announced financial results for the three
and six-month periods ended June 30,
2019.
"Cryoport reported revenue of $8.5
million for the three-month period ended June 30, 2019, an increase of 83% compared with
the same period in the prior year," stated Jerrell Shelton, Chief Executive Officer of
Cryoport.
"Revenue from our commercial agreements supporting Gilead's
YESCARTA® and Novartis'
KYMRIAH® contributed $1.9 million in the Second Quarter of 2019 as
volumes continued to ramp in their respective ongoing commercial
rollouts. Revenue from these commercial products represent a 320%
increase compared with the same quarter last year and a sequential
increase of 34% over the First Quarter of 2019. The continued
global rollout of YESCARTA® and KYMRIAH® is
expected to drive sustained momentum and revenue growth for
Cryoport.
"A milestone during the quarter was the European Union's
Conditional Marketing Authorization for bluebird bio's ZYNTEGLO™,
which represents the third commercially approved product that we
support. ZYNTEGLO™ is the first gene therapy approved for
transfusion-dependent β-thalassemia (TDT), a severe genetic disease
caused by mutations in the β-globin gene that results in reduced or
absent hemoglobin. Logistics requirements are expected to ramp
in 2020 with the commercial launch, driving revenue to Cryoport. We
are proud to be working with bluebird bio to bring this pioneering
therapy to patients.
"We added a net total of 30 clinical trials during the Second
Quarter, bringing the grand total of regenerative therapy clinical
trials supported by Cryoport to a record 413, of which 52 are
currently in Phase III. As the regenerative medicine market
continues to gain pace, we expect to continue to grow the number of
clinical trials we support, which, together with the increasing
number of cell therapies that are approaching commercialization,
will continue to be a main source of revenue growth.
"The global Regenerative Medicine market continues to experience
significant growth with a range of diverse therapies entering
development. Data provided by the Alliance for Regenerative
Medicine states that there are currently a total of 1,069 clinical
trials in the Regenerative Medicine market globally, with 358
trials in Phase I, 617 in Phase II, and 94 in Phase III. We
continue to focus on adding clinical trials as a core part of our
strategy as the industry approaches its inflection point and many
therapies advance toward commercialization. Demand for
temperature-controlled logistics solutions is expected to
significantly increase as these therapies are approved across new
indications and countries.
"We think the growth of the regenerative medicine market has
just begun; and, to support this growth, we will continue to
further build out our ecosystem to better serve all our life
sciences markets through investing in infrastructure, forming
strategic partnerships and developing new, innovative solutions for
the life sciences.
"During the Second Quarter, we entered the bioservices market
through the acquisition of Cryogene Partners, a Houston-based company that operates a 21,000
square foot state-of-the-art biostorage facility. This acquisition
was immediately accretive, contributing approximately $577,000 to Cryoport's revenue for the Second
Quarter. We expect Cryogene's revenues to grow over the next
several quarters as it continues to attract new customers and
further serve its major customers in the region, such as MD
Anderson, Houston Methodist Hospital, Texas Childrens, Bellicum,
and Merck.
"We believe Cryoport is well capitalized with approximately
$95 million in cash and short term
investments to execute on its growth strategies in all its markets,
which we expect to provide us with the financial wherewithal to
finance our growth, to continue our global infrastructure buildout,
to invest in new product offerings, and to build out our global
supply chain network. Our strong balance sheet also allows us to
more aggressively pursue acquisitions and other strategic
initiatives that will further entrench Cryoport within this new and
expanding life sciences ecosystem."
Highlights by market:
Biopharma
- Biopharma revenue increased by 81% to $7.0 million for the three months ended
June 30, 2019 compared to
$3.8 million for the same period in
2018.
- A net addition of 30 new biopharma trials were added during the
three months ended June 30,
2019.
- Cryoport is supporting a net total of 413 clinical trials as of
June 30, 2019 compared with 283 as of
June 30, 2018. The number of trials
in Phase III grew to 52, compared with 41 as of June 30, 2018. Of the 413 total trials we
support, 353 are in the Americas, 53 in EMEA (Europe, the Middle
East and Africa) and seven
in APAC (Asia Pacific), as of
June 30, 2019. This compares to 257
in the Americas, 25 in EMEA and one in APAC, as of June 30, 2018.
- Formed a strategic alliance with EVERSANA™ to further develop
another fully integrated regenerative medicine supply chain
solution. The alliance is designed to leverage EVERSANA's position
as the leading provider of commercial services addressing access,
affordability and adherence challenges for cell and gene therapies
and Cryoport's suite of temperature-controlled logistics solutions
to ensure a safe and effective supply chain solution for innovative
therapeutic advancements.
Animal Health
- Revenue from the Animal Health remained flat with $0.3 million for both, the three months ended
June 30, 2019 and 2018.
Reproductive Medicine
- Reproductive Medicine revenue increased 34% for the three
months ended June 30, 2019 compared
to the same period in 2018, growing both domestically as well as
internationally.
Bioservices
- Bioservices revenue for the three months ended June 30, 2019 was $0.6
million, resulting from the acquisition of the Cryogene
business consummated during the quarter.
Financial Highlights:
- Revenue increased 83% to $8.5
million for the three-month period ended June 30, 2019, compared with the same period in
the prior year.
- Revenue increased 75% to $15.1
million for the six-month period ended June 30, 2019, compared with the same period in
the prior year.
- Excluding the Cryogene acquisition consummated in May of 2019,
revenue grew 71% and 68% for the three and six-month periods ended
June 30, 2019, compared with the same
period in the prior year.
- Gross margin for the three and six-months ended June 30, 2019 was 51% and 52%, respectively,
compared to 54% for both periods in the prior year.
- As a result of in the continued investments in the build out of
infrastructure, including the addition of two new Global Logistics
Centres in the U.S. and Europe
during the second half of 2018, new competencies and services,
operating costs and expenses increased by $1.7 million, and $3.3
million, for the three and six-month periods ended
June 30, 2019, respectively, compared
to the same periods in the prior year.
- Adjusted EBITDA for the three-month period ended June 30, 2019 was $0.3
million, compared with ($0.8
million) in the same three-month period in the prior year.
Adjusted EBITDA for the six-month period ended June 30, 2019, was ($0.1
million), compared with ($1.4
million) in the same six-month period in the prior
year.
- Net loss for the three-month period ended June 30, 2019 was $2.5
million, or $0.08 per share,
compared to a net loss of $2.5
million, or $0.09 per share in
the same three-month period in 2018.
- Net loss for the six-month period ended June 30, 2019 was $4.9
million, or $0.16 per share,
compared with $5.2 million, or
$0.19 per share, in the same
six-month period in 2018.
- Cryoport reported $94.7 million
in cash, cash equivalents and short-term investments as of
June 30, 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 during the three-month period ended
June 30, 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 is provided in Cryoport's quarterly report on
Form 10-Q for the three-month period ended June 30, 2019, which will be filed with the
Securities and Exchange Commission ("SEC") on August 9, 2019. 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 2019 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, August 8. 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 8,
2019. 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:
|
Thursday, August 8,
2019
|
Time:
|
5:00 p.m.
ET
|
Dial-in
numbers:
|
+1 (855) 327-6837
(U.S.) or +1 (631) 891-4304 (International)
|
Confirmation
code:
|
Request "Cryoport
Call" or provide code 10007349
|
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 Cryoport's
website at www.cryoport.comfor 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 August 15, 2019. To access the replay, dial
+1 (844) 512-2921 (United States)
or +1 (412) 317-6671 (International) and enter replay pin number:
10007349.
About Cryoport, Inc.
Cryoport, Inc. ("Cryoport") is the premier provider of
temperature-controlled solutions to the life sciences industry
through its purpose-built proprietary packaging, information
technology, specialized cold chain logistics expertise, and
biostorage and biobanking services. The Company provides leading
edge solutions to the biopharma, reproductive medicine and animal
health markets to ship, store and deliver biologic materials, such
as immunotherapies, stem cells, CAR-T cell therapies, vaccines and
reproductive cells for clients worldwide Cryoport
actively supports pharmaceutical and biotechnology companies,
points-of-care, contract research organizations, central
laboratories, contract manufacturers, university researchers and
other entities service the life sciences industry.
Cryoport's proprietary Cryoport
Express® Shippers, Cryoportal® Logistics
Management Platform, leading-edge SmartPak II™ Condition Monitoring
System and geo-sensing technology, paired with unparalleled cold
chain logistics expertise and 24/7 client support, make Cryoport
the end-to-end cold chain logistics partner that the industry
trusts.
For more information, visit www.cryoport.com. Sign up to
follow @cryoport on Twitter at www.twitter.com/cryoport.
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. It is important to note that Cryoport'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 Cryoport's cash flow, market
acceptance risks, and technical development risks. 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, 2018 filed with the SEC.
Cryoport 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
|
|
|
|
Consolidated
Statements of Operations
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
June 30,
|
|
Six Months
Ended
June 30,
|
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Revenues
|
|
$
8,463,588
|
|
$
4,627,011
|
|
$
15,116,500
|
|
$
8,650,200
|
Cost of
revenues
|
4,125,199
|
|
2,123,304
|
|
7,324,210
|
|
3,962,130
|
Gross
margin
|
4,338,389
|
|
2,503,707
|
|
7,792,290
|
|
4,688,070
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
|
General and
administrative
|
3,258,781
|
|
2,668,845
|
|
5,955,640
|
|
4,737,355
|
|
Sales and
marketing
|
2,843,073
|
|
1,851,456
|
|
5,251,065
|
|
3,435,884
|
|
Engineering and
development
|
540,933
|
|
448,591
|
|
1,030,529
|
|
778,321
|
Total operating costs
and expenses
|
6,642,787
|
|
4,968,892
|
|
12,237,234
|
|
8,951,560
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(2,304,398)
|
|
(2,465,185)
|
|
(4,444,944)
|
|
(4,263,490)
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Interest
expense
|
(333,910)
|
|
-
|
|
(672,638)
|
|
-
|
|
Warrant inducement
and repricing expense
|
-
|
|
-
|
|
-
|
|
(899,410)
|
|
Other income,
net
|
119,441
|
|
7,120
|
|
210,913
|
|
22,888
|
Loss before provision
for income taxes
|
(2,518,867)
|
|
(2,458,065)
|
|
(4,906,669)
|
|
(5,140,012)
|
Provision for income
taxes
|
(9,624)
|
|
(12,825)
|
|
(8,724)
|
|
(13,638)
|
Net
loss
|
|
$
(2,528,491)
|
|
$
(2,470,890)
|
|
$
(4,915,393)
|
|
$
(5,153,650)
|
|
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted
|
$
(0.08)
|
|
$
(0.09)
|
|
$
(0.16)
|
|
$
(0.19)
|
Weighted average
shares outstanding - basic and diluted
|
31,176,166
|
|
27,808,873
|
|
30,811,109
|
|
27,294,384
|
Cryoport Inc. and
Subsidiaries
|
Condensed
Consolidated Balance Sheets
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
December
31,
|
|
|
|
2019
|
|
2018
|
|
|
|
(unaudited)
|
|
|
Current
Assets:
|
|
|
|
|
Cash and cash
equivalents
|
$
80,642,213
|
|
$
37,327,125
|
|
Short-term
investments
|
14,103,653
|
|
9,930,968
|
|
Accounts receivable,
net
|
6,095,858
|
|
3,543,666
|
|
Inventories
|
306,438
|
|
220,514
|
|
Prepaid expenses and
other current assets
|
526,648
|
|
752,269
|
|
|
Total current
assets
|
101,674,810
|
|
51,774,542
|
Property and
equipment, net
|
10,338,007
|
|
4,357,498
|
Operating lease
right-of-use assets
|
4,160,747
|
|
-
|
Goodwill
|
|
11,149,663
|
|
-
|
Other intangible
assets, net
|
5,415,499
|
|
137,220
|
Deposits
|
|
407,369
|
|
350,837
|
|
|
Total
assets
|
$
133,146,095
|
|
$
56,620,097
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable and
other accrued expenses
|
$
3,416,805
|
|
$
1,709,397
|
|
Accrued compensation
and related expenses
|
1,534,468
|
|
1,262,478
|
|
Operating lease
liabilities
|
534,586
|
|
-
|
|
Deferred
revenue
|
221,776
|
|
66,315
|
|
Finance lease
obligations
|
25,940
|
|
23,191
|
|
|
Total current
liabilities
|
5,733,575
|
|
3,061,381
|
|
Convertible note,
net
|
14,722,625
|
|
14,711,580
|
|
Operating lease
liabilities, net
|
3,920,739
|
|
-
|
|
Deferred rent
liability, net
|
-
|
|
267,415
|
|
Finance lease
obligations, net
|
18,981
|
|
33,156
|
|
|
Total
liabilities
|
24,395,920
|
|
18,073,532
|
|
|
Total stockholders'
equity
|
108,750,175
|
|
38,546,565
|
|
|
Total liabilities and
stockholders' equity
|
$
133,146,095
|
|
$
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 the following
non-GAAP financial measure, adjusted EBITDA, to 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
Subsidiaries
|
|
|
|
Adjusted EBITDA
Reconciliation
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
June 30,
|
|
Six Months
Ended
June 30,
|
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
GAAP net
loss
|
$
(2,528,491)
|
|
$
(2,470,890)
|
|
$
(4,915,393)
|
|
$
(5,153,650)
|
|
Non-GAAP adjustments
to net loss:
|
|
|
|
|
|
|
|
|
|
Depreciation and
amortization expense
|
496,690
|
|
191,359
|
|
797,255
|
|
379,193
|
|
|
Interest expense,
net
|
280,648
|
|
-
|
|
563,701
|
|
-
|
|
|
Stock-based
compensation expense
|
1,991,755
|
|
1,445,729
|
|
3,405,490
|
|
2,495,239
|
|
|
Warrant inducement
and repricing expense
|
-
|
|
-
|
|
-
|
|
899,410
|
|
|
Income
taxes
|
9,624
|
|
12,825
|
|
8,724
|
|
13,638
|
Adjusted
EBITDA
|
$
250,226
|
|
$
(820,977)
|
|
$
(140,223)
|
|
$
(1,366,170)
|
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SOURCE Cryoport, Inc.