Cryoport Revenue Grows 76% for Third Quarter 2018; 91% Growth in Biopharma

Actualizado el 8 de noviembre, 2018 - 22.10hs.

Cryoport Revenue Grows 76% for Third Quarter 2018; 91% Growth in Biopharma

295 Regenerative Medicine Clinical Trials Now Supported by Cryoport; 38 Programs in Phase III

Revenue from Commercialized CAR-T Therapies Continues to Ramp

PR Newswire

IRVINE, Calif., Nov. 8, 2018 /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 nine-month periods ended September 30, 2018.

Cryoport, Inc.

"Third quarter revenue increased 76% year-over-year to $5.3 million," Jerrell Shelton, Chief Executive Officer of Cryoport, commented. "This growth was driven by the 37 new clinical trial agreements in the quarter, in addition to securing $555,000 in commercial revenue as we scaled our agreements to support the first two FDA and EMA approved CAR-T therapies, Novartis' Kymriah® and Gilead's Yescarta®. Over the last 12 months, we have added a net total of 100 clinical trials, bringing the grand total of regenerative therapy clinical trials supported by Cryoport to a record 295, of which 38 are currently in Phase III.

"During the quarter, The European Commission granted Marketing Authorization for both Yescarta® and Kymriah®, approving these treatments for use in the 28 countries of the European Union, Norway, Iceland and Liechtenstein. Moreover, Yescarta® and Kymriah® also received National Health Service (NHS) approval for the United Kingdom. Cryoport's agreements with Gilead and Novartis cover these global expansions of services, which are expected to further drive near term revenue growth. This, coupled with the rapidly increasing number of clinical stage therapies that we support along with advances in the regenerative medicine market that are propelling these therapies toward commercialization, provides additional momentum to our business. So far, in 2018 four Marketing Authorization Applications (MAAs) have been filed in Europe and one Biologics Licensing Application (BLA) in the United States.  We expect an additional BLA in the United States to be filed before year's end based on internal information and the forecast from the Alliance for Regenerative Medicine. 

"To expand our reach even further within the regenerative medicine industry we are forming strategic partnerships that will enable us to deliver our recently launched Chain of Compliance™ solution, which offers full traceability of equipment, processes, and handling of cell and gene therapies while in transit, to biopharmaceutical companies globally. Both World Courier and Be The Match BioTherapies®, which are leaders in cell therapy supply chain management, have chosen to include our solutions in their respective offerings, Mr. Shelton continued.

"While these initiatives, among others, continue to advance our strategy in the Biopharma market, we are also focused on executing on our growth strategies in both the Reproductive Medicine and Animal Health markets. The launch of CryoStork® Insurance, which is designed to better serve intended parents, coupled with continued progress in the Animal Health market, is expected to further contribute to our growth," concluded Mr. Shelton.

Market Highlights:

Biopharma

  • Biopharma revenue increased by 91% in the three months ended September 30, 2018 compared to the same period in 2017.
  • 37 new biopharma clinical trials were added, on a net total basis, in the three-months ended September 30, 2018 compared with the three-months ended June 30, 2018.
  • Cryoport is supporting a net total of 295 clinical trials compared with 195 as of the three-months ended September 30, 2017. The number of trials in Phase III grew from 20 as of the three-months ended September 30, 2017 to 38 during the quarter ended September 30, 2018.
  • Cryoport continued to support the commercial ramp of Novartis' Kymriah® and Gilead-Kite's Yescarta®. Revenue from these commercial agreements accounted for approximately $555,000 in the quarter.
  • The Company partnered with Be The Match BioTherapies® to deliver integrated end-to-end supply chain services to the cell and gene therapy industry.
  • Cryoport expects another BLA to be filed in 2018, bringing the 2018 total to six pre-commercial filings.

Animal Health

  • Revenue from the Animal Health market was 8% less for the three months ended September 30, 2018 compared to the same period in 2017.

Reproductive Medicine

  • Reproductive Medicine revenue increased by 43% for the three months ended September 30, 2018 compared to the same period in 2017, driven by both, domestic and international demand.
  • CryoStork® Insurance, which is designed to better serve intended parents, was launched in response to the rise in demand for assisted reproductive medicine.

Financial Highlights:

  • Revenue increased 76% to $5.3 million and 61% to $13.9 million for the three and nine-month periods ended September 30, 2018, respectively, compared with the same periods in the prior year, while operating costs and expenses increased 36% and 40%, for the same periods, respectively.
  • Gross margin for the three and nine-month periods ended September 30, 2018 was 52% and 53% respectively, compared with 54% and 49% for the same three and nine-month periods, respectively, in the prior year. Gross margin for the third quarter of 2018 was slightly impacted by the running costs for the new logistics centers established in the U.S. and Europe, which commenced operations during the quarter.
  • As referenced above, operating costs and expenses increased by $1.3 million, and $4.0 million, for the three and nine-month periods ended September 30, 2018, respectively, including our investments in the build out of infrastructure, such as adding two logistics centers, as well as new competencies and services.
  • Adjusted EBITDA for the three and nine-month periods ended September 30, 2018 was ($0.4 million) and ($1.8 million), respectively, compared with ($0.8 million) and ($2.6 million) in the same three- and nine-month periods in the prior year.
    The Company has no debt and reported $23.7 million in cash, cash equivalents and short-term investments as of September 30, 2018, compared with $15.0 million as of December 31, 2017.

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-Q for the three and nine-month periods ended September 30, 2018, which will be filed with the Securities and Exchange Commission ("SEC") on November 8, 2018. 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

Date:

Thursday, November 8, 2018

Time:

4:30 p.m. ET

Dial-in numbers:

+1 (877) 407-9716 (U.S.) or +1 (201) 493-6779 (International)  

Confirmation code:

Request "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 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 15, 2018.  To access the replay, dial +1 (844) 512-2921 (United States) or 1 (412) 317-6671 (International) and enter replay pin number: 13684169.

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

 Consolidated Statements of Operations

(unaudited)



 Three Months Ended 
September 30, 


 Nine Months Ended
September 30, 


2018


2017


2018


2017

Revenues

$       5,285,355


$      3,002,655


$   13,935,555


$        8,632,267

Cost of revenues

2,549,348


1,396,158


6,511,478


4,379,084

Gross margin

2,736,007


1,606,497


7,424,077


4,253,183









Operating costs and expenses:









General and administrative

2,613,476


1,896,845


7,350,831


5,389,391


Sales and marketing

1,820,430


1,352,974


5,256,314


3,659,742


Engineering and development

463,361


344,798


1,241,682


825,377

Total operating costs and expenses

4,897,267


3,594,617


13,848,827


9,874,510









Loss from operations

(2,161,260)


(1,988,120)


(6,424,750)


(5,621,327)

Other income (expense):









Interest expense

-


-


-


(15,693)


Warrant inducement and repricing expense

-


-


(899,410)


-


Other income, net

19,675


8,456


42,563


11,919

Loss before provision for income taxes

(2,141,585)


(1,979,664)


(7,281,597)


(5,625,101)

Provision for income taxes

(2,102)


-


(15,740)


(4,231)

Net loss 

$     (2,143,687)


$   (1,979,664)


$   (7,297,337)


$      (5,629,332)









Net loss per share - basic and diluted

$                (0.07)


$              (0.08)


$              (0.26)


$                 (0.25)

Weighted average shares outstanding - basic and diluted

28,769,867


24,632,169


27,791,616


22,093,169

 

Cryoport Inc. and Subsidiaries

Condensed Consolidated Balance Sheets










September 30,


December 31,




2018


2017




(unaudited)



Current Assets:





Cash and cash equivalents

$     13,849,644


$   15,042,189


Short-term investments

9,884,918


-


Accounts receivable, net

3,197,224


1,625,476


Inventories

130,299


114,796


Prepaid expenses and other current assets

882,141


516,427



Total current assets

27,944,226


17,298,888

Property and equipment, net

3,578,494


2,511,174

Intangible assets, net

124,822


90,646

Deposits 


351,844


363,403



Total assets

$     31,999,386


$   20,264,111







Current liabilities:





Accounts payable and other accrued expenses

$       1,885,003


$      1,232,975


Accrued compensation and related expenses

884,893


925,514


Deferred revenue

15,387


26,654



Total current liabilities

2,785,283


2,185,143


Deferred rent liability

179,707


192,202



Total liabilities

2,964,990


2,377,345



Total stockholders' equity

29,034,396


17,886,766



     Total liabilities and stockholders' equity 

$     31,999,386


$   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 Subsidiaries

Adjusted EBITDA Reconciliation

(unaudited)





 Three Months Ended
September 30, 


 Nine Months Ended
September 30, 




2018


2017


2018


2017

GAAP net loss 

$  (2,143,687)


$  (1,979,664)


$  (7,297,337)


$  (5,629,332)


Non-GAAP adjustments to net loss:










Depreciation and amortization expense

214,000


184,075


593,193


491,980



Interest expense

-


-


-


15,693



Stock-based compensation expense

1,498,663


964,857


3,993,902


2,529,858



Warrant inducement and repricing expense

-


-


899,410


-



Income taxes

2,102


-


15,740


4,231

Adjusted EBITDA

$      (428,922)


$      (830,732)


$  (1,795,092)


$  (2,587,570)

 

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SOURCE Cryoport, Inc.

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