IRVINE, Calif., March 7, 2019 /PRNewswire/ -- Cryoport, Inc.
(NASDAQ: CYRX) (NASDAQ: CYRXW) ("Cryoport" or the "Company"), the
world's leading temperature-controlled logistics company dedicated
to the life sciences industry, today announced financial results
for the three and twelve-month periods ended December 31, 2018.
Jerrell Shelton, Chief Executive
Officer of Cryoport, commented, "For 2018 we reported record
revenue of $19.6 million,
representing growth of 64% over our fiscal year 2017, driven
primarily by an 81% increase in the Biopharma market. This was the
result of the ramp in commercial regenerative medicine products we
are supporting and significant growth in the number of clinical
trials supported by Cryoport in the Americas and EMEA (Europe, the Middle
East and Africa), a region
we will now report separately given its growing significance.
"At the end of 2018, clinical trials supported by Cryoport
increased to a total of 357, which includes 40 in the EMEA
region. A record 47 trials are in Phase III, of which 9 are
in the EMEA region. This reflects the continued and rapid
maturation of the regenerative medicine market and, specifically,
the progress our clients are making in advancing their potentially
life-saving therapies to market.
"Revenue from our commercial agreements to provide logistics
support for Gilead's Yescarta™ and Novartis' Kymriah™ totalled
$2.1 million for 2018 as they rolled
out their therapies to patient populations in the United States. This revenue growth is
expected to accelerate throughout 2019 as the U.S. rollout
continues and the first revenues are generated in Europe,
Australia, Canada and Japan.
"In 2018 the global regenerative medicine market experienced
significant growth, resulting in a rich and diverse pipeline of
therapies. This generated significant investor interest, with
$13.3 billion invested in the global
regenerative medicine market in 2018, up 73% from 2017, according
to the Alliance for Regenerative Medicine. Four Marketing
Authorization Applications (MAA's) were filed in Europe and two Biologics Licensing
Applications (BLA's) were filed in the
United States during 2018. We expect this momentum to
continue, with six additional Cryoport supported BLA and MAA
submissions expected in 2019, based on internal information and
forecasts from the Alliance for Regenerative Medicine and Wells
Fargo Securities."
Moving to the Company's newly introduced Chain of
Compliance™ and infrastructure build out, Mr. Shelton said, "To
continue to strengthen and solidify our position as the world's
leading specialty logistic solutions provider for the life sciences
industry, we have built a strong foundation upon which to scale our
operations as our markets mature, including launching our Chain
of Compliance™ solution for Biopharma, which offers complete
traceability throughout our temperature-controlled logistics
solutions. Furthermore, with the opening of two state-of-the-art
Cryoport Global Logistics Centers located in Livingston, New Jersey and Amsterdam, The Netherlands, we continue to add
to our capacity and redundancy, enabling us to further improve our
services to the global market. Our expanding Global Logistics
Network supports our goal of ever improving our services in the
Biopharma market for commercial, clinical and pre-clinical
clients.
"Our leadership in the industry coupled with these investments
in infrastructure has enabled Cryoport to continue securing
valuable partnerships, such as our recent announced agreements with
Dacos A/S, a high-tech production company of life sciences products
with headquarters in Denmark, as
well as McKesson and Be The Match BioTherapies®, to
offer integrated, end-to-end supply chain services to the cell and
gene therapy industry. These agreements add to our ecosystem and
are expected to: (i) increase market penetration of our solutions,
(ii) provide a unified platform for compliance standardization and
(iii) drive meaningful revenue growth, both in the near and
long-term."
Mr. Shelton continued, "In the fourth quarter of 2018, we also
secured a $25 million investment from
Petrichor Healthcare Capital Management to provide us with the
financial flexibility to build, scale and create value for our
shareholders. Consequently, we entered 2019 with a strong balance
sheet and the ability to capitalize on market opportunities. As we
have said in the past, we are actively pursuing potential
acquisitions that have the ability to broaden and/or strengthen our
ability to serve the life sciences industry and especially those
that would enable us to provide more comprehensive support to the
Biopharma market as it pushes the boundaries of medicine."
Mr. Shelton concluded, "As a result of the strong growth in
Biopharma market revenue in 2018, our revenue from the Reproductive
Medicine and Animal Health markets contributed a lesser proportion
of our total revenue. However, they are solid and growing markets
and we will continue to invest in them. Our best-in-class
technology for the Reproductive Medicine market has driven
increased adoption of our solutions tailored to this market's
needs. In the Animal Health market, our revenue has fluctuated
throughout the year as a result of fulfilling special one-time
requirements. Both markets show growing demand for our solutions
and we expect to grow our presences in them, respectively, in
2019."
Market Highlights:
Biopharma
- Biopharma revenue increased by 81% in the twelve months ended
December 31, 2018 compared to the
same period in 2017; for the quarter ended December 31, 2018, biopharma revenue increased
94% compared to the same period in 2017.
- Cryoport is supporting a net total of 357 clinical trials in
the Americas and EMEA, of which 47 are in Phase III, compared with
237 as of December 31, 2017, 33 of
which were in Phase III.
- Partnered with Dacos A/S ("Dacos"), a high-tech production
company of life sciences products with headquarters in Denmark, to deliver temperature-controlled
logistics solutions to Dacos' global client base of
biopharmaceutical companies.
- Opened our new Global Logistics Center in Amsterdam, The Netherlands, near the Schiphol
Amsterdam Airport, which serves as one of the European Union's main
aviation hubs for international air traffic.
Animal Health
- Revenue from the Animal Health market declined 14% for the
twelve months ended December 31, 2018
compared to the same period in 2017 as a result of some one-time
activity in 2017; for the quarter ended December 31, 2018, Animal Health revenue declined
35% compared to the same period in 2017 as a result of
non-recurring activity in 2017.
Reproductive Medicine
- Reproductive Medicine revenue increased by 27% for the twelve
months ended December 31, 2018
compared to the same period in 2017; for the quarter ended
December 31, 2018, Reproductive
Medicine revenue increased 30% compared to the same period in
2017.
Financial Highlights:
- Revenue increased 64% to $19.6
million and 71% to $5.7
million for the twelve and three-month periods ended
December 31, 2018, respectively,
compared with the same periods in the prior year. This growth was
driven by an overall increase in the number of clients utilizing
the Company's solutions complemented by growth and frequency of
shipments from current clients, including the increase in revenue
from our commercial agreements with Novartis and Gilead.
- Gross margin for the twelve and three months ended December 31, 2018 was 52% and 50%, respectively,
compared to 50% and 52% for the same periods in the prior year,
respectively.
- As a result of investments in the build out of infrastructure
during 2018, which includes adding two new Global Logistics
Centers, new competencies and services, operating costs and
expenses increased by $5.0 million
and $1.1 million for the twelve and
the three-month periods ended December 31,
2018, respectively, as compared to the same periods in
2017.
- Net losses for the twelve and three-month periods ended
December 31, 2018 were $9.6 million, or $0.34 per share, and $2.3
million, or $0.08 per share,
respectively. This is compared to net losses of $7.9 million, or $0.34 per share, and $2.3
million, $0.09 per share, for
the same twelve and three-month periods in the prior year.
- Adjusted EBITDA for the twelve and three-month periods ended
December 31, 2018 was ($2.2 million) and ($0.4
million), respectively, compared with ($3.7 million) and ($1.1
million) for the same twelve and three-month periods in the
prior year.
- The Company reported $47.3
million in cash and cash equivalents and short-term
investments as of December 31, 2018,
compared to $15.0 million as of
December 31, 2017. The increase in
cash and cash equivalents includes gross proceeds of $25 million from Petrichor Healthcare Capital
Management.
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 annual report on
Form 10-K for the twelve and three-month periods ended December 31, 2018, which will be filed with the
Securities and Exchange Commission ("SEC") on March 12, 2019. The full report will be available
on the SEC Filings section of the Investor Relations section of the
Company's website at www.cryoport.com.
Earnings Conference Call Information
A document titled "Cryoport 2018 Year in Review", which will
provide a review of Cryoport's recent financial and operational
performance and a general business outlook, will be issued by
management at 4:05 pm EST on
Thursday, March 7. The document is designed to be read by
investors before the question and answer 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 EST on March 7,
2019. 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:
|
Thursday, March 7,
2019
|
Time:
|
5:00 p.m.
ET
|
Dial-in
numbers:
|
+1 (877) 407-9716
(U.S.) or +1 (201) 493-6779 (International)
|
Confirmation
code:
|
Request "Cryoport
Call" or provide code 13687775
|
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 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 14, 2019. To access the replay, dial
+1 (844) 512-2921 (United States)
or +1 (412) 317-6671 (International) and enter replay pin number:
13687775.
About Cryoport, Inc.
Cryoport is the life sciences
industry's most trusted global provider of temperature-controlled
logistics solutions for temperature-sensitive life sciences
commodities, serving the biopharmaceutical market with leading-edge
logistics solutions for biologic materials, such as regenerative
medicine, including immunotherapies, stem cells and CAR T-cells.
Cryoport's solutions are used by points-of-care, CRO's, central
laboratories, pharmaceutical companies, manufacturers, university
researchers et al; as well as the reproductive medicine market,
primarily in IVF and surrogacy; and the animal health market,
primarily in the areas of vaccines and reproduction. 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.
Cryoport is dedicated to: simplifying global cold chain
logistics through innovative technology, unmatched monitoring and
data capture and support, including consulting; delivering the most
advanced temperature-controlled logistics solutions for the life
sciences industry; and providing vital information that provides
peace of mind throughout the life of each logistics process.
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, 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, 2017 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,
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|
(unaudited)
|
|
(unaudited)
|
|
|
|
|
Revenues
|
$
5,690,898
|
|
$
3,322,000
|
|
$
19,626,453
|
|
$
11,954,267
|
Cost of
revenues
|
2,874,710
|
|
1,608,750
|
|
9,386,188
|
|
5,987,834
|
Gross
margin
|
2,816,188
|
|
1,713,250
|
|
10,240,265
|
|
5,966,433
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
|
General and
administrative
|
2,447,962
|
|
2,031,446
|
|
9,798,793
|
|
7,420,837
|
|
Sales and
marketing
|
1,989,330
|
|
1,572,664
|
|
7,245,644
|
|
5,232,406
|
|
Engineering and
development
|
598,761
|
|
380,315
|
|
1,840,443
|
|
1,205,692
|
Total operating costs
and expenses
|
5,036,053
|
|
3,984,425
|
|
18,884,880
|
|
13,858,935
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(2,219,865)
|
|
(2,271,175)
|
|
(8,644,615)
|
|
(7,892,502)
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Interest
expense
|
(69,253)
|
|
-
|
|
(69,253)
|
|
(15,693)
|
|
Warrant inducement
and repricing expense
|
-
|
|
-
|
|
(899,410)
|
|
-
|
|
Other income,
net
|
35,068
|
|
2,418
|
|
77,631
|
|
14,337
|
Loss before provision
for income taxes
|
(2,254,050)
|
|
(2,268,757)
|
|
(9,535,647)
|
|
(7,893,858)
|
Provision for income
taxes
|
(4,214)
|
|
(912)
|
|
(19,954)
|
|
(5,143)
|
Net loss
|
(2,258,264)
|
|
(2,269,669)
|
|
(9,555,601)
|
|
(7,899,001)
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders - basic and diluted
|
$
(0.08)
|
|
$
(0.09)
|
|
$
(0.34)
|
|
$
(0.34)
|
Weighted average
shares outstanding - basic and diluted
|
29,454,077
|
|
25,545,645
|
|
28,210,648
|
|
22,963,382
|
Cryoport Inc. and
Subsidiaries
|
Condensed
Consolidated Balance Sheets
|
|
|
|
|
December
31,
|
|
|
|
2018
|
|
2017
|
Current
Assets:
|
|
|
|
|
Cash and cash
equivalents
|
$
37,327,125
|
|
$
15,042,189
|
|
Short-term
investments
|
9,930,968
|
|
-
|
|
Accounts receivable,
net
|
3,543,666
|
|
1,625,476
|
|
Inventories
|
220,514
|
|
114,796
|
|
Prepaid expenses and
other current assets
|
752,269
|
|
516,427
|
|
|
Total current
assets
|
51,774,542
|
|
17,298,888
|
Property and
equipment, net
|
4,357,498
|
|
2,511,174
|
Intangible assets,
net
|
137,220
|
|
90,646
|
Deposits
|
350,837
|
|
363,403
|
|
|
Total
assets
|
$
56,620,097
|
|
$
20,264,111
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable and
other accrued expenses
|
$
1,709,397
|
|
$
1,203,354
|
|
Accrued compensation
and related expenses
|
1,262,478
|
|
925,514
|
|
Deferred
revenue
|
66,315
|
|
73,444
|
|
Capital lease
obligations
|
23,191
|
|
-
|
|
|
Total current
liabilities
|
3,061,381
|
|
2,202,312
|
|
Convertible note,
net
|
14,711,580
|
|
-
|
|
Deferred rent
liability, net
|
267,415
|
|
175,033
|
|
Capital lease
obligations, net
|
33,156
|
|
-
|
|
|
Total
liabilities
|
18,073,532
|
|
2,377,345
|
|
|
Total stockholders'
equity
|
38,546,565
|
|
17,886,766
|
|
|
Total liabilities and
stockholders' equity
|
$
56,620,097
|
|
$
20,264,111
|
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
the Company'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 the
Company's operating results, a meaningful comparison with
historical results and with the results of other companies, and
insight into the Company's ongoing operating performance. Further,
management and the Board of Directors utilize these non-GAAP
financial measures to gain a better understanding of the Company'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 the Company's GAAP financials, are useful to
investors because they provide a basis for meaningful
period-to-period comparisons of the Company's ongoing operating
results, including results of operations, against investor and
analyst financial models, identifying trends in the Company's
underlying business and performing related trend analyses, and they
provide a better understanding of how management plans and measures
the Company's underlying business.
Cryoport Inc. and
Subsidiary
|
Adjusted EBITDA
Reconciliation
|
(unaudited)
|
|
|
|
|
Three Months
Ended
December 31,
|
|
Year Ended
December 31,
|
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
GAAP net
loss
|
$
(2,258,264)
|
|
$
(2,269,669)
|
|
$
(9,555,601)
|
|
$
(7,899,001)
|
|
Non-GAAP adjustments
to net loss:
|
|
|
|
|
|
|
|
|
|
Depreciation and
amortization expense
|
264,746
|
|
172,851
|
|
857,939
|
|
664,831
|
|
|
Interest
expense
|
69,253
|
|
-
|
|
69,253
|
|
15,693
|
|
|
Stock-based
compensation expense
|
1,484,723
|
|
1,017,923
|
|
5,478,625
|
|
3,547,781
|
|
|
Warrant repricing
expense
|
-
|
|
-
|
|
899,410
|
|
-
|
|
|
Income
taxes
|
4,214
|
|
912
|
|
19,954
|
|
5,143
|
Adjusted
EBITDA
|
$
(435,328)
|
|
$
(1,077,983)
|
|
$
(2,230,420)
|
|
$
(3,665,553)
|
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SOURCE Cryoport, Inc.