IRVINE, Calif., May 2, 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-month period ended March 31,
2019.
Jerrell Shelton, Chief Executive
Officer of Cryoport stated, "Our revenue increased 65% to
$6.7 million for the three-month
period ended March 31, 2019, compared
with the same period in the prior year. Revenue from our commercial
agreements supporting Gilead's Yescarta® and
Novartis' Kymriah® was
$1.4 million in the First Quarter of
2019, representing a 374% increase compared with the same quarter
last year and a sequential increase of 74% over the Fourth Quarter
of 2018. We continue to work in lockstep with Gilead and Novartis
to increase market penetration and help their respective,
much-needed CAR-T cell therapies safely reach patients around the
world. Our commercial revenue from these agreements were driven by
the advancement of the rollouts in the Americas and EMEA
(Europe, Middle East, and Africa) regions.
"We now support 383 clinical trials, up from 261 for the same
quarter last year and representing a net gain of 26 over the Fourth
Quarter of 2018. As the regenerative market continues to grow, we
continue to secure new agreements with world-leading regenerative
medicine companies in all geographic regions. As examples,
Celularity, a placental-based allogeneic cell therapy company,
recently selected Cryoport's complete range of
temperature-controlled solutions to support its clinical trials and
Biokin Pharma, a China-based
biopharmaceutical company, partnered with Cryoport for its pending
Phase I and II clinical trials in immuno-oncology in both the U.S.
and China. We think this momentum
will continue to drive accelerated revenue growth throughout the
remainder of 2019 as we secure new agreements and our clients'
clinical pipelines continue to advance. Examples of other market
drivers include the following: Subsequent to the quarter end, the
FDA agreed to a rolling review of Mesoblast's Biologics License
Application (BLA) for its cell therapy for children with
steroid-refractory acute graft versus host disease (aGVHD).
Secondly, in the United States,
the Centers for Medicare and Medicaid ("CMS") stated they are
considering several changes to payment policies for CAR-T in 2020
to drive improved patient access to these much-needed therapies.
CMS also confirmed that CAR-Ts will continue to be eligible for New
Technology Add-on Payment (NTAP) and that it would increase NTAP
from 50% of the cost of the therapy to 65%. The current maximum
NTAP is $186,000 and they are
recommending it be increased to $242,450.
"To meet current and future global demand from our Biopharma
clients both in clinical and commercial stages, we are building a
Global Logistics Network. Today we have four Global Logistics
Centers and one Embedded Logistics Center. Our new Global Logistics
Centers in New Jersey and
The Netherlands are ramping
revenue significantly, which we expect to continue throughout 2019.
By focusing on establishing a networked presence in leading life
sciences hubs around the world, driven by client activity, we
believe we are strategically positioning the Company at the core of
the growth which will take place in the global cellular therapy
market and which will drive significant revenue growth for
Cryoport.
"In addition to the fast-growing opportunities in the Biopharma
market, we are strengthening our growth strategies in the
Reproductive Medicine and Animal Health markets, both of which, we
believe, have considerable upside opportunity. For our first
quarter of 2019, revenue from Reproductive Medicine increased 56%
year over year, as a result of our marketing initiatives and
growing brand recognition in this market, driving stronger demand
in the Americas and EMEA.
"In closing, we are working diligently to continue to support
our clients with the most sophisticated and reliable
temperature-controlled solutions in the life sciences industry, to
build on our client base across all our markets and, of course, to
build value for our long-term shareholders."
Market Highlights:
Biopharma
- Biopharma revenue increased by 72% in the three months ended
March 31, 2019 compared to the same
period in 2018.
- A net addition of 26 new biopharma trials were added in the
three months ended March 31,
2019.
- Cryoport is supporting a net total of 383 clinical trials
compared with 261 as of March 31,
2018. The number of trials in Phase III grew to 49, compared
with 38 as of March 31, 2018.
- Selected by Amgen to be its primary provider of
temperature-controlled logistics solutions. Under the terms of the
agreement, Cryoport will support Amgen's cryogenic shipments of its
biomaterials globally. By employing the Cryoport Express™ High
Volume Dry Vapor Shippers, Amgen will ensure the safe transport and
delivery of its high value Global Cell Bank and other critical
commodities as it pursues the engineering and commercialization of
CAR T-cell therapies.
- Selected by Celularity, a world leading placental based
allogeneic cell therapy company, to utilize its complete range of
temperature-controlled solutions.
- Selected to support Biokin Pharma's pending Phase I and II
clinical trials in immuno-oncology in both the U.S. and
China.
- Activity is significantly ramping at new Global Logistics
Centers in Amsterdam, The
Netherlands and Livingston,
NJ.
- Based on internal information and forecasts from the Alliance
for Regenerative Medicine and Wells Fargo Securities, we reiterate
our expectation for five additional Cryoport supported BLA and MAA
submissions to occur this year.
Animal Health
- Revenue from the Animal Health market declined 5% for the three
months ended March 31, 2019 compared
to the same period in 2018 as a result of non-recurring activity in
the previous year.
Reproductive Medicine
- Reproductive Medicine revenue increased by 56% for the three
months ended March 31, 2019 compared
to the same period in 2018, as a result of strong demand in the
Americas and EMEA.
Financial Highlights:
- Revenue increased 65% to $6.7
million for the three-month period ended March 31, 2019, compared with the same period in
the prior year.
- Gross margin for the three months ended March 31, 2019 was 52%, compared to 54% for the
same period in the prior year.
- As a result of investments in the build out of infrastructure
during 2018, which included adding two new Global Logistics
Centers, new competencies and services, operating costs and
expenses increased by $1.6 million
for the three-month period ended March 31,
2019, as compared to the same period in 2018.
- Net loss for the three-month period ended March 31, 2019 was $2.4
million, or $0.08 per share.
This is compared to a net loss of $2.7
million, or $0.10 per share,
for the same three-month period in the prior year.
- Adjusted EBITDA for the three-month period ended March 31, 2019 was ($0.3
million), compared with ($0.5
million) for the three-month period in the prior year.
- The Company reported $47.3
million in cash and cash equivalents and short-term
investments as of March 31, 2019 and
as of December 31, 2018.
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 March 31, 2019, which will be filed with the
Securities and Exchange Commission ("SEC") on May 8, 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
IMPORTANT INFORMATION: A document titled "Cryoport First
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, May 2. 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 May 2,
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, May 2,
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 10006692
|
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 May 9, 2019.
To access the replay, dial +1 (844) 512-2921 (United States) or +1 (412) 317-6671
(International) and enter replay pin number: 10006692.
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, 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
|
|
|
|
March
31,
|
|
|
|
2019
|
|
2018
|
|
Revenues
|
|
$
6,652,912
|
|
$
4,023,189
|
|
Cost of
revenues
|
|
3,199,011
|
|
1,838,826
|
|
Gross
margin
|
|
3,453,901
|
|
2,184,363
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
General and
administrative
|
|
2,696,859
|
|
2,068,510
|
|
|
Sales and
marketing
|
|
2,407,992
|
|
1,584,428
|
|
|
Engineering and
development
|
|
489,596
|
|
329,730
|
|
Total operating costs
and expenses
|
|
5,594,447
|
|
3,982,668
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(2,140,546)
|
|
(1,798,305)
|
|
Other income
(expense):
|
|
|
|
|
|
|
Interest
expense
|
|
(338,728)
|
|
-
|
|
|
Warrant repricing
expense
|
|
-
|
|
(899,410)
|
|
|
Other income,
net
|
|
91,472
|
|
15,768
|
|
Loss before provision
for income taxes
|
|
(2,387,802)
|
|
(2,681,947)
|
|
Benefit (provision)
for income taxes
|
|
900
|
|
(813)
|
|
Net
loss
|
|
$
(2,386,902)
|
|
$
(2,682,760)
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted
|
|
$
(0.08)
|
|
$
(0.10)
|
|
Weighted average
shares outstanding - basic and diluted
|
|
30,441,996
|
|
26,774,179
|
|
Cryoport Inc. and
Subsidiaries
|
|
Condensed
Consolidated Balance Sheets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
December
31,
|
|
|
|
|
|
2019
|
|
2018
|
|
|
|
|
|
(unaudited)
|
|
|
|
Current
Assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
32,771,986
|
|
$
37,327,125
|
|
|
Short-term
investments
|
|
14,500,748
|
|
9,930,968
|
|
|
Accounts receivable,
net
|
|
4,208,333
|
|
3,543,666
|
|
|
Inventories
|
|
227,090
|
|
220,514
|
|
|
Prepaid expenses and
other current assets
|
|
741,614
|
|
752,269
|
|
|
|
Total current
assets
|
|
52,449,771
|
|
51,774,542
|
|
Property and
equipment, net
|
|
5,124,655
|
|
4,357,498
|
|
Operating lease
right-of-use assets
|
|
1,711,727
|
|
-
|
|
Intangible assets,
net
|
|
157,708
|
|
137,220
|
|
Deposits
|
|
350,494
|
|
350,837
|
|
|
|
Total
assets
|
|
$
59,794,355
|
|
$
56,620,097
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts payable and
other accrued expenses
|
|
$
2,326,143
|
|
$
1,709,397
|
|
|
Accrued compensation
and related expenses
|
|
1,753,499
|
|
1,262,478
|
|
|
Operating lease
liabilities
|
|
390,790
|
|
-
|
|
|
Deferred
revenue
|
|
37,918
|
|
66,315
|
|
|
Finance lease
obligations
|
|
23,531
|
|
23,191
|
|
|
|
Total current
liabilities
|
|
4,531,881
|
|
3,061,381
|
|
|
Convertible note,
net
|
|
14,707,215
|
|
14,711,580
|
|
|
Operating lease
liabilities, net
|
|
1,621,183
|
|
-
|
|
|
Deferred rent
liability, net
|
|
-
|
|
267,415
|
|
|
Finance lease
obligations, net
|
|
27,138
|
|
33,156
|
|
|
|
Total
liabilities
|
|
20,887,417
|
|
18,073,532
|
|
|
|
Total stockholders'
equity
|
|
38,906,938
|
|
38,546,565
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
59,794,355
|
|
$
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 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
Subsidiaries
|
Adjusted EBITDA
Reconciliation
|
(unaudited)
|
|
|
|
|
Three Months
Ended
March 31,
|
|
|
|
|
2019
|
|
2018
|
|
GAAP net
loss
|
$
(2,386,902)
|
|
$
(2,682,760)
|
|
|
Non-GAAP adjustments
to net loss:
|
|
|
|
|
|
|
Depreciation and
amortization expense
|
300,565
|
|
187,834
|
|
|
|
Interest
expense
|
338,728
|
|
-
|
|
|
|
Stock-based
compensation expense
|
1,413,735
|
|
1,049,510
|
|
|
|
Warrant repricing
expense
|
-
|
|
899,410
|
|
|
|
Income
taxes
|
(900)
|
|
813
|
|
Adjusted
EBITDA
|
$
(334,774)
|
|
$
(545,193)
|
|
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SOURCE Cryoport, Inc.