Full Press Release Details
Iovance Biotherapeutics Reports Fourth
Quarter and Full-Year 2017 Financial Results
and Provides Corporate Update
- Company to Host Conference Call at 4:30pm
SAN CARLOS, CA - March 12, 2018 -- Iovance Biotherapeutics,
Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL)
technology, today reported its fourth quarter and year-end 2017 financial results and provided a corporate update.
"We ended 2017 having completed significant accomplishments
involving both manufacturing and clinical aspects of development of TIL as a viable commercial therapy. We developed a new manufacturing
method, lasting 22 days and yielding a cryopreserved product, conducted a clinical study investigating the efficacy of this method,
reported preliminary data showing responses from this generation 2 manufacturing method in late-line metastatic melanoma patients
and subsequently selected this manufacturing method for all ongoing and future clinical trials for Iovance. We have also expanded
our manufacturing capacity in the US, in commercial-ready suites, and built out our capacity in the EU. On the clinical front,
we are currently running four studies to evaluate the potential breadth of utility of TIL therapy in multiple indications,"
said Dr. Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. "In early 2018, we successfully
completed a common stock public offering adding approximately $162 million in net proceeds to the cash reserves. The proceeds from
this public offering, combined with the year-end cash balance, puts us in a strong position to execute on our upcoming milestones."
2017 Achievements and
Fourth Quarter and Full-Year 2017 Financial and Operating
At December 31, 2017, the company held $145.4 million in cash,
cash equivalents and short-term investments, compared to $166.5 million at December 31, 2016. Net cash used in operating activities
was $78.7 million during the year ended December 31, 2017.
Iovance anticipates cash, cash equivalents and investments to
be between $190 million and $210 million at December 31, 2018.
The company is providing both GAAP
and non-GAAP financial information. All non-GAAP information excludes amounts related to stock-based compensation. See "Use
of Non-GAAP Financial Measures" below for a description of the company's non-GAAP Financial Measures. Reconciliation
between certain GAAP and non-GAAP measures is provided at the end of this press release.
GAAP and Non-GAAP Net Loss Attributable
to Common Stockholders
GAAP net loss attributable to common
stockholders for the quarter ended December 31, 2017 was $25.9 million, or $0.36 per share, compared to GAAP net loss of $15.7
million or $0.25 per share for the quarter ended December 31, 2016.
Non-GAAP net loss attributable to common
stockholders for the quarter ended December 31, 2017 was $23.1 million, or $0.32 per share, compared to $12.6 million, or $0.20
per share for the quarter ended December 31, 2016. The non-GAAP net loss for the quarters ended December 31, 2017 and 2016 excludes
$2.8 million and $3.1 million of non-cash stock-based compensation, respectively.
GAAP net loss attributable to common
stockholders for the year ended December 31, 2017 was $92.1 million, or $1.41 per share, compared to $102.3 million or $1.85 per
share for the year ended December 31, 2016. The 2016 GAAP net loss attributable to common stockholders included a one-time deemed
dividend related to a charge of $49.5 million incurred because of the conversion feature of the Series B convertible preferred
stock. Non-GAAP net loss for the year ended December 31, 2017 was $80.1 million, or $1.23 per share, compared to non-GAAP net loss
of $34.0 million or $0.62 per share for the year ended December 31, 2016. The non-GAAP net loss for the years ended December 31,
2017 and 2016 excludes $12.0 million and $18.9 million of non-cash stock-based compensation, respectively. The 2016 non-GAAP net
loss also excludes the one-time charge of $49.5 million related to the deemed dividend.
GAAP and Non-GAAP Expenses
GAAP research and development (R&D) expenses were $20.7
million for the quarter ended December 31, 2017, an increase of $10.6 million compared to $10.1 million for the quarter ended December
31, 2016. The increase in R&D expenses is due to increased spending on clinical activities and manufacturing. R&D associated
stock-based compensation expense was $0.9 million for the three months ended December 31, 2017 and $1.5 million for the three months
ended December 31, 2016. Non-GAAP R&D expenses were $19.8 million for the quarter ended December 31, 2017, an increase of $11.1
million, compared to $8.7 million for the quarter ended December 31, 2016.
GAAP general and administrative (G&A) expenses were $5.4
million for the quarter ended December 31, 2017, a decrease of $0.5 million compared to $5.8 million for the quarter ended December
31, 2016. G&A associated stock-based compensation expense was $1.8 million for the three months ended December 31, 2017 and
$1.7 million for the three months ended December 31, 2016. Non-GAAP G&A expenses were $3.5 million for the quarter ended December
31, 2017, a decrease of $0.6 million, compared to $4.1 million for the quarter ended December 31, 2016.
Use of Non-GAAP Financial Measures
This press release contains non-GAAP
financial measures, including expenses adjusted to exclude certain non-cash expenses. These measures are not in accordance with,
or an alternative to, generally accepted accounting principles (GAAP), and may be different from non-GAAP financial measures used
by other companies. The items included in GAAP presentations but excluded for purposes of determining non-GAAP financial measures
for the periods presented in this press release are: (i) the non-cash stock-based compensation expense which may fluctuate from
period-to-period based on factors including the timing and accounting of grants for stock options and changes in the company's
stock price which impacts the fair value of options granted, and (ii) the one-time non-cash deemed dividend related to the conversion
feature of the Series B Preferred Stock. The company believes the presentation of non-GAAP financial measures provides useful information
to management and investors regarding various financial and business trends relating to the company's financial condition
and results of operations. When GAAP financial measures are viewed in conjunction with non-GAAP financial measures, investors are
provided with a more meaningful understanding of Iovance's ongoing operating performance. In addition, these non-GAAP financial
measures are among those indicators the company uses as a basis for evaluating operational performance, allocating resources and
planning and forecasting future periods. Non-GAAP financial measures are not intended to be considered in isolation or as a substitute
for GAAP financial measures. To the extent this release contains historical or future non-GAAP financial measures, the company
has also provided corresponding GAAP financial measures for comparative purposes. Reconciliation between certain GAAP and non-GAAP
measures is provided at the end of this press release. Beginning in 2018, Iovance will no longer report non-GAAP expenses or non-GAAP
Webcast and Conference Call
Iovance will host a conference call today at 4:30 p.m. ET to
discuss these fourth quarter and full-year 2017 results and provide a corporate update. The conference
call dial-in numbers are: 1-844-646-4465 (domestic) or 1-615-247-0257 (international). The conference ID access number for the
call is 1497629. The live webcast can be accessed under "News & Events" in the "Investors" section
of the company's website at http://www.iovance.com/ or you may use the link:
A replay of the call will be
available from March 12, 2018 at 7:30 p.m. ET to April 18, 2018 at 8:30 p.m. ET. To access the replay, please dial 1-855-859-2056
(domestic) or 1-404-537-3406 (international). The conference ID number for the replay is 1497629. The archived webcast will be
available for thirty days in the Investors section of Iovance Biotherapeutics' website at http://www.iovance.com.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. is a clinical-stage biotechnology
company focused on the development of cancer immunotherapy products for the treatment of various cancers. The company's lead product
candidate is an adoptive cell therapy using tumor-infiltrating lymphocyte (TIL) technology being investigated for the treatment
of patients with metastatic melanoma, recurrent and/or metastatic squamous cell carcinoma of the head and neck, recurrent, metastatic
or persistent cervical cancer, and locally advanced or metastatic non-small cell lung cancer. For more information, please visit http://www.iovance.com.
Forward-Looking Statements
Certain matters discussed in this press release are "forward-looking
statements". We may, in some cases, use terms such as "predicts," "believes," "potential,"
"continue," "estimates," "anticipates," "expects," "plans," "intends,"
"may," "could," "might," "will," "should" or other words that convey
uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the company's statements
regarding trends and potential future results are examples of such forward-looking statements. These forward-looking statements
include, but are not limited to, the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for
our current product candidates, including statements regarding the timing of initiation and completion of the trials; the timing