IRVINE, Calif., Nov. 7, 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 nine-month periods ended September 30,
2019.
"Cryoport reported record revenue of $9.6
million for the three-month period ended September 30, 2019, an increase of 81% compared
with the same period in the prior year," stated Jerrell Shelton, Chief Executive Officer of
Cryoport. "This was primarily driven by record revenue from our
commercial agreements supporting Gilead's YESCARTA® and
Novartis' KYMRIAH® which contributed $2.6 million in the Third Quarter of 2019,
representing an increase of $2.0
million compared with the Third Quarter of 2018.
Notably, this also represents a 39% sequential quarterly
increase in revenue over the Second Quarter of 2019. We expect
revenue from our commercial agreements to continue to grow and
accelerate as the rollouts of these lifesaving therapies continue.
We also anticipate that this growth will be supplemented with
bluebird bio's anticipated commercial launch of ZYNTEGLO™ in in
early 2020 and followed by others later in the year.
"Our growth in the Third Quarter was also attributable to
Bioservices revenue of $1.2 million
from our Houston based operation,
Cryogene. We have begun to leverage Cryogene with cross-selling
opportunities that we believe will drive revenue growth and provide
more comprehensive supply chain solutions to existing and
prospective clients.
"Our global footprint continues to mature as our Global
Logistics Centre in Amsterdam
experienced higher revenue driven by strong regional demand
for reliable, integrated manufacturing and distribution solutions
during the quarter. To further expand our Global Supply Chain
Network, we are building partnerships with multinational
biopharmaceutical companies and biopharmaceutical support companies
in order to advance our mission to provide cell and gene therapy
developers with fully integrated supply chain solutions.
"We recently signed an agreement with, Swiss based, Lonza, one
of the world's leading and most-trusted integrated solutions
providers to the pharmaceutical, biotech, and consumer health
markets. This agreement makes Cryoport a Lonza preferred
partner in the transport and delivery of patient materials on
a global basis. Lonza has twenty-four major sites located
throughout the world, including four centers of excellence in cell
and gene therapy. Its flagship dedicated cell and gene therapy
manufacturing facility is located in Houston, Texas. This state-of-the-art
manufacturing facility produces treatments for thousands of
patients suffering from rare genetic disorders or life-threatening
diseases. It is the intent of Lonza and Cryoport that through their
new partnership, they will drive supply chain and manufacturing
efficiencies in the cell and gene therapy manufacturing processes
by integrating Cryoport's logistics and bioservices solutions with
Lonza's manufacturing services and expertise. The Lonza-Cryoport
partnership is expected to provide a best in class solution for the
outsourced manufacturing and logistics of cell and gene
therapies.
"We also partnered with Vineti to pair their supply chain
orchestration (SCO) platform with our integrated
temperature-controlled supply chain capabilities and near real-time
monitoring. This partnership provides end-to-end solutions for
advanced therapies, supporting improved product quality and patient
safety.
"Other recent announcements include a three-year agreement with
Adaptimmune Therapeutics plc, to optimize Adaptimmune's
manufacturing and supply operations and reduce "vein-to-vein" time
for patients in clinical trials. Forming valuable industry
partnerships such as these further integrates Cryoport into the
market at a time when biopharmaceutical companies are discovering
new ways to harness regenerative therapies and combat
illnesses.
"During the Third Quarter, we added a net total of 12 clinical
trials, bringing the grand total of regenerative therapy clinical
trials supported by Cryoport to a record 425, of which 54 are
currently in Phase III. As more and more of these therapies
approach commercialization, demand for reliable, integrated
outsourced manufacturing and distribution solutions continues to
increase. As the clear market leader, Cryoport is poised to capture
additional market share and expand as the market grows.
"Data provided by the Alliance for Regenerative Medicine states
that there are five anticipated BLA or MAA submissions in the
remainder of 2019 or early 2020 for therapies supported by
Cryoport. Data provided by the Alliance for Regenerative
Medicine states that there are currently a total of 1,052 clinical
trials in the Regenerative Medicine market, globally, with 363
trials in Phase I, 594 in Phase II, and 95 in Phase
III.
"With our strong business model and approximately
$94 million in cash and short-term
investments, we believe we are well positioned to drive growth
organically and through acquisitions as we further enmesh ourselves
within the Regenerative Medicine industry and build out our global
supply chain network at this pivotal time in the market's
evolution. With this strong foundation, we look forward to
continuing to advance our mission to bring life changing therapies
to patients while building shareholder value."
Market Highlights:
Global Logistics Solutions
Biopharma
- Biopharma revenue increased by 67% to $7.5 million for the three months ended
September 30, 2019 compared to
$4.5 million for the same period in
2018.
- A net addition of 12 new biopharma clinical trials were added
during the three months ended September 30,
2019.
- Cryoport is now supporting a net total of 425 clinical trials
as of September 30, 2019 compared
with 323 as of September 30, 2018.
The number of trials in Phase III grew to 54, compared with 46 as
of September 30, 2018. Of the 425
total trials Cryoport supports, 360 are in the Americas, 55 in EMEA
(Europe, the Middle East and Africa) and 10 in APAC (Asia Pacific). This compares to 295 in the
Americas and 28 in EMEA as of September 30,
2018.
- Lonza announced Cryoport as its preferred partner in the
transport and delivery of patient tissues on a global basis, with
the continued goal of seamless service for Lonza's customers and
their patients.
- Vineti announced a commercial partnership with Cryoport
designed to extend end-to-end delivery of cell therapies and gene
therapies to a growing number of patients. Pairing Cryoport's
integrated temperature-controlled capabilities and near real-time
monitoring with Vineti's supply chain orchestration (SCO) platform
with will support improved drug product quality for advanced
therapies and patient safety.
- Cryoport announced the industry's first Advanced Therapy
Shipper™ in its Cryoport Express® product line for the
Regenerative Medicine market. The Cryoport Express®
Advanced Therapy Shipper™ guarantees each shipper has been used
only for human use and provides complete traceability of all
equipment, components and commodities. The result is an industry
first, providing unmatched verification information and supply
chain support for biopharma companies researching and
commercializing cell and gene therapies.
Animal Health
Revenue from Animal Health was $0.2
million for both the three months ended September 30, 2019 and 2018. We are now in a
position to grow our revenue in the Animal Health market through
new dedicated resources that are focused on this market on a global
basis. During the quarter we made significant increases in
our Animal Health pipeline, which we anticipate translating to
revenue growth in 2020.
Reproductive Medicine
Reproductive Medicine revenue increased 26% for the three months
ended September 30, 2019 compared to
the same period in 2018, growing both domestically as well as
internationally. This growth can be attributed to increasing
awareness of our CryostorkTM platform which was launched
in 2018 as well as maturing commercial relationships with large
clinic networks.
Global Bioservices
Bioservices revenue for the three months ended September 30, 2019 was $1.2 million, resulting from our acquisition of
the Cryogene business consummated in May
2019.
Financial Highlights:
- Revenue increased 81% to $9.6
million for the three-month period ended September 30, 2019, compared with the same period
in the prior year.
- Revenue increased 77% to $24.7
million for the nine-month period ended September 30, 2019, compared with the same period
in the prior year.
- Excluding the $1.2 million of
revenue for the three months ended September
30, 2019 from the Cryogene acquisition, consummated in May
of 2019, revenue grew 59% and 65% for the three and nine-month
periods ended September 30, 2019,
compared with the same period in the prior year.
- Gross margin for the three and nine-months ended September 30, 2019 was 48% and 50%, respectively,
compared to 52% and 53% for both the respective periods in the
prior year.
- Third quarter financial results include a one-time charge of
$10.8 million in stock-based
compensation expense (non-cash) of which $0.4 million and $10.4
million are included in cost of revenues and operating costs
and expenses, respectively. This charge reflects 24 months of
automatic accelerated vesting under the terms of certain
outstanding stock option grants as a result of the Company meeting
certain financial performance criteria defined in such grants,
including reaching positive adjusted EBITDA for two consecutive
quarters.
- Operating costs and expenses increased by $12.1 million, and $15.4
million, for the three and nine-month periods ended
September 30, 2019, respectively,
compared to the same periods in the prior year, as a result of
$10.4 million in one-time accelerated
stock-based compensation expenses (as explained above) as well as
continued investments in the build out of infrastructure, including
the addition of two new Global Logistics Centers in the U.S. and
Europe during the second half of
2018. Without one-time accelerated stock-based compensation
expenses the operating costs and expenses increased by $1.7 million, and $5.0
million, for the three and nine-month periods ended
September 30, 2019, respectively,
compared to the same periods in the prior year.
- Adjusted EBITDA for the three-month period ended September 30, 2019 was $1.2 million, compared with ($0.4 million) in the same three-month period in
the prior year. Adjusted EBITDA for the nine-month period ended
September 30, 2019, was $0.9 million, compared with ($1.8 million) in the same nine-month period in
the prior year.
- Net loss for the three-month period ended September 30, 2019 was $12.5 million, or $0.35 per share (Adjusted net loss was
$1.7 million, or $0.05 per share, excluding the one-time charge of
$10.8 million in accelerated vesting
stock-based compensation expense), compared to a net loss of
$2.1 million, or $0.07 per share in the same three-month period in
2018.
- Net loss for the nine-month period ended September 30, 2019 was $17.4 million, or $0.54 per share (Adjusted net loss was
$6.6 million, or $0.20 per share, excluding the one-time charge of
$10.8 million in accelerated vesting
stock-based compensation expense), compared with $7.3 million, or $0.26 per share, in the same nine-month period in
2018.
- Cryoport reported $93.5 million
in cash, cash equivalents and short-term investments as of
September 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 completed in June
2019.
- Subsequent to the quarter end, Cryoport's Board of Directors
unanimously authorized a share repurchase program, under which
Cryoport may repurchase up to $15
million of its outstanding common stock through December 31, 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 is provided in Cryoport's quarterly report on
Form 10-Q for the three-month period ended September 30, 2019, which will be filed with the
Securities and Exchange Commission ("SEC") on November 12, 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 Third
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, November 7. 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 November 7,
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 Conference Call
Information
Date:
|
November 7,
2019
|
Time:
|
5:00 p.m.
ET
|
Dial-in
numbers:
|
+1 (800) 895-3361
(U.S.) or +1 (785) 424-1062 (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 November 14, 2019.
To access the replay, dial +1 (844) 512-2921 (United States) or +1 (412) 317-6671
(International) and enter replay pin number: 136824.
About Cryoport, Inc.
Cryoport, Inc. (Nasdaq: CYRX) is the world's premier
provider of temperature-controlled supply chain solutions for the
life sciences industry, serving the Biopharma, Human
Reproductive, 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, 2018 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
|
|
|
|
Consolidated
Statements of Operations
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
Three Months Ended September
30,
|
|
Nine
Months Ended
September 30,
|
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Revenues
|
|
$
9,583,334
|
|
$
5,285,355
|
|
$
24,699,834
|
|
$
13,935,555
|
Cost of
revenues
|
4,956,277
|
|
2,549,348
|
|
12,280,487
|
|
6,511,478
|
Gross
margin
|
4,627,057
|
|
2,736,007
|
|
12,419,347
|
|
7,424,077
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
|
General and
administrative
|
9,376,686
|
|
2,613,476
|
|
15,332,326
|
|
7,350,831
|
|
Sales and
marketing
|
5,961,593
|
|
1,820,430
|
|
11,212,658
|
|
5,256,314
|
|
Engineering and
development
|
1,640,528
|
|
463,361
|
|
2,671,057
|
|
1,241,682
|
Total operating costs
and expenses
|
16,978,807
|
|
4,897,267
|
|
29,216,041
|
|
13,848,827
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(12,351,750)
|
|
(2,161,260)
|
|
(16,796,694)
|
|
(6,424,750)
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Interest
expense
|
(248,410)
|
|
-
|
|
(921,048)
|
|
-
|
|
Warrant inducement
and repricing expense
|
-
|
|
-
|
|
-
|
|
(899,410)
|
|
Other income,
net
|
133,499
|
|
19,675
|
|
344,412
|
|
42,563
|
Loss before provision
for income taxes
|
(12,466,661)
|
|
(2,141,585)
|
|
(17,373,330)
|
|
(7,281,597)
|
Provision for income
taxes
|
(1,886)
|
|
(2,102)
|
|
(10,610)
|
|
(15,740)
|
Net
loss
|
|
$
(12,468,547)
|
|
$
(2,143,687)
|
|
$
(17,383,940)
|
|
$
(7,297,337)
|
|
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted
|
$
(0.35)
|
|
$
(0.07)
|
|
$
(0.54)
|
|
$
(0.26)
|
Weighted average
shares outstanding - basic and diluted
|
35,674,162
|
|
28,769,867
|
|
32,449,940
|
|
27,791,616
|
Cryoport Inc. and
Subsidiaries
|
Condensed
Consolidated Balance Sheets
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
|
|
2019
|
|
2018
|
|
|
|
(unaudited)
|
|
|
Current
Assets:
|
|
|
|
|
Cash and cash
equivalents
|
$
44,585,154
|
|
$
37,327,125
|
|
Short-term
investments
|
48,917,336
|
|
9,930,968
|
|
Accounts receivable,
net
|
7,497,190
|
|
3,543,666
|
|
Inventories
|
350,920
|
|
220,514
|
|
Prepaid expenses and
other current assets
|
872,436
|
|
752,269
|
|
|
Total current
assets
|
102,223,036
|
|
51,774,542
|
Property and
equipment, net
|
11,378,987
|
|
4,357,498
|
Operating lease
right-of-use assets
|
4,612,788
|
|
-
|
Goodwill
|
|
11,149,663
|
|
-
|
Other intangible
assets, net
|
5,286,690
|
|
137,220
|
Deposits
|
|
406,686
|
|
350,837
|
|
|
Total
assets
|
$
135,057,850
|
|
$
56,620,097
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable and
other accrued expenses
|
$
3,130,663
|
|
$
1,709,397
|
|
Accrued compensation
and related expenses
|
1,567,365
|
|
1,262,478
|
|
Deferred
revenue
|
423,537
|
|
66,315
|
|
Lease
liablility
|
562,866
|
|
|
|
Finance lease
obligations
|
24,252
|
|
23,191
|
|
|
Total current
liabilities
|
5,708,683
|
|
3,061,381
|
|
Convertible note,
net
|
14,738,622
|
|
14,711,580
|
|
Operating lease
liabilities, net
|
4,266,589
|
|
-
|
|
Deferred rent
liability, net
|
-
|
|
267,415
|
|
Finance lease
obligations, net
|
14,834
|
|
33,156
|
|
|
Total
liabilities
|
24,728,728
|
|
18,073,532
|
|
|
Total stockholders'
equity
|
110,329,122
|
|
38,546,565
|
|
|
Total liabilities and
stockholders' equity
|
$
135,057,850
|
|
$
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
Subsidiaries
|
|
Adjusted EBITDA
Reconciliation
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
September 30,
|
|
Nine Months
Ended
September 30,
|
|
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
GAAP net
loss
|
$
(12,468,547)
|
|
$
(2,143,687)
|
|
$
(17,383,940)
|
|
$
(7,297,337)
|
|
|
Non-GAAP adjustments
to net loss:
|
|
|
|
|
|
|
|
|
|
|
Depreciation and
amortization expense
|
792,916
|
|
214,000
|
|
1,590,171
|
|
593,193
|
|
|
|
Interest expense,
net
|
114,911
|
|
-
|
|
576,636
|
|
-
|
|
|
|
Stock-based
compensation expense
|
1,945,775
|
|
1,498,663
|
|
5,351,265
|
|
3,993,902
|
|
|
|
Accelerated vesting
stock-based compensation expense
|
10,789,774
|
|
-
|
|
10,789,774
|
|
-
|
|
|
|
Warrant inducement
and repricing expense
|
-
|
|
-
|
|
-
|
|
899,410
|
|
|
|
Income
taxes
|
1,886
|
|
2,102
|
|
10,610
|
|
15,740
|
|
Adjusted
EBITDA
|
$
1,176,715
|
|
$
(428,922)
|
|
$
934,516
|
|
$
(1,795,092)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cryoport Inc. and
Subsidiaries
|
Adjusted Net Loss and
Net Loss per Share Reconciliation
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
September 30,
|
|
Nine Months
Ended
September 30,
|
|
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
GAAP net
loss
|
$
(12,468,547)
|
|
$
(2,143,687)
|
|
$
(17,383,940)
|
|
$
(7,297,337)
|
|
|
Accelerated vesting
stock-based compensation expense
|
10,789,774
|
|
-
|
|
10,789,774
|
|
-
|
|
Adjusted net
loss
|
$
(1,678,773)
|
|
$
(2,143,687)
|
|
$
(6,594,166)
|
|
$
(7,297,337)
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted net loss per
share - basic and diluted
|
$
(0.05)
|
|
$
(0.07)
|
|
$
(0.20)
|
|
$
(0.26)
|
|
Weighted average
shares outstanding - basic and diluted
|
35,674,162
|
|
28,769,867
|
|
32,449,940
|
|
27,791,616
|
|
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SOURCE Cryoport, Inc.