MENLO PARK, Calif.,
Dec. 14, 2015 /PRNewswire/
-- BioPharmX Corporation (NYSE MKT: BPMX), a specialty
pharmaceutical company focusing on dermatology and women's health,
today announced its financial results for the third fiscal quarter
ended October 31, 2015.
Recent Highlights:
- Completed a direct investment of approximately $5.9 million in gross proceeds through the sale
of 4,100,000 shares of the company's common stock at a purchase
price of $1.43 per share to
investment vehicles of Franklin Advisers.
- Announced early positive pre-clinical data for BPX-01, the
company's unique topical formulation of minocycline, suggesting a
1% dose works as well as other 4% topical products under
development, reducing potential side effects.
- Added 3,025 GNC store locations supplying Violet® iodine, the
company's breast health supplement, raising its U.S. retail
footprint to more than 7,500 stores.
- Appointed AnnaMarie Daniels, a
life science industry veteran, as executive vice president of
clinical and regulatory affairs.
"We continue to make meaningful progress in our strategic and
clinical development initiatives," said Jim
Pekarsky, chief executive officer. "We are delighted to have
secured additional financing, as well as the confidence of Franklin
Advisers in our product development and growth plans. Their direct
investment has bolstered our balance sheet and enables further
investment in our clinical programs and product pipeline. We are in
a unique and exciting position today as we move towards further
clinical development of our topical acne treatment and other
initiatives in our pipeline. We look forward to bringing the
benefits of our health and wellness products to patients."
Third Quarter Financial Results
Total operating
expenses were $3.8 million for the quarter ended October 31, 2015, compared to $2.2
million the prior year quarter primarily as a result of
increased expenditures for the company's acne drug pre-clinical
preparations and continued marketing and commercialization efforts
for Violet iodine.
Net loss for the third quarter was $3.9 million, or
$0.18 per share, compared to a
net loss of $2.3 million, or $0.21 per share, during
the prior year quarter.
Excluding stock-based compensation expense and amortization of
purchased intangible assets, non-GAAP net loss for the third
quarter was $3.6 million, or
$0.17 per share, compared with a net
loss of $1.9 million, or $0.18 per share, during the prior year
quarter.
Cash and cash equivalents as of October
31, 2015 were $2.2
million. Since the close of the third quarter, the
company completed a direct investment with Franklin Advisers of
approximately $5.9 million in gross
proceeds. The company also expects proceeds of $2 million in cash from the closing of a
previously announced private placement with Korea Investment
Partners Overseas Expansion Platform Fund, an existing
shareholder.
Management Overview and Recent Business Developments
Beyond its first commercially available product, Violet iodine,
BioPharmX Corporation is also pursuing the development of novel
products targeting large dermatologic markets. These
include:
BPX-01
BPX-01, the company's topical acne drug, will
deliver minocycline in a directly applied, gel-like treatment that
effectively treats acne, but with fewer expected side effects than
its oral counterpart. During the third quarter, the company
presented pre-clinical data at three key dermatology seminars
suggesting that a 1% dose of minocycline in BPX-01 can work as well
as the 4% topical products that are under development by
competitors, lowering the likelihood of side effects. The company
expects to file an IND with the FDA for BPX-01 and currently
anticipates Phase 2 (505)(b) clinical trials to commence in early
calendar year 2016.
BPX-02
BPX-02 is still in research mode as the company
continues to make progress in the development of a prescription
drug formulating biologics materials for a dermatology
application.
BPX-03 and Violet Iodine
BPX-03, the company's
prescription strength molecular iodine product that complements its
Violet iodine product, is in development and the company plans to
complete a multi-site IRB study over the next 12 months in
preparation for Phase 3 trials. Phases 1 and 2 of these
trials have already been completed. Both the Violet iodine
supplement and BPX-03 are uniquely formulated for the treatment of
fibrocystic breast condition as well as overall breast
health.
Conference Call & Webcast
BioPharmX will host a
conference call at 4:30 p.m. Eastern
Time on Monday, December 14,
2015 to discuss its third quarter financial results. A live
webcast of the conference call will be available online on the
Investor page of BioPharmX corporate website at www.biopharmx.com.
You may also access this call through an operator by calling (866)
652-5200 for domestic callers and (412) 317-6060 for international
callers, and request to join the BioPharmX Corporation call.
A telephonic replay of the call will be available through
midnight ET on December 15, 2015. The replay dial-in numbers are
(877) 344-7529 for domestic callers and (412) 317-0088 for
international callers; and reference Conference ID: 10076919. The
webcast will also be available on the BioPharmX website for 90 days
following completion of the call.
About BioPharmX® Corporation
BioPharmX Corporation
(NYSE MKT: BPMX) is a Silicon Valley-based specialty pharmaceutical
company, which seeks to provide products through proprietary
platform technologies for prescription, over-the-counter (OTC), and
supplement applications in the health and wellness markets,
including dermatology and women's health. To learn more about
BioPharmX, visit www.BioPharmX.com.
Use of Non-GAAP Measures
BioPharmX Corporation has
supplemented its reported GAAP financial information with non-GAAP
measures, non-GAAP net loss available to common shareholders, and
non-GAAP net loss available to common shareholders per share,
that do not include a one-time charge related to the modification
of certain warrants, stock-based compensation and the amortization
of purchased intangible assets. The presentation of this
additional information is not meant to be considered in isolation
or as a substitute for results prepared in accordance with
GAAP. Management uses the non-GAAP information internally to
evaluate its ongoing business, operational performance and cash
requirements and believes these non-GAAP measures are useful to
investors as they provide the same basis for evaluating BioPharmX
Corporation's performance as applied by management.
BioPharmX Corporation has provided a reconciliation of each
non-GAAP financial measure to the most directly comparable GAAP
financial measure. These non-GAAP measures may be different
from non-GAAP measures used by other companies, including peer
companies, and therefore, comparability may be limited. In
addition, these non-GAAP measures are not based on any
comprehensive set of accounting rules or principles.
BioPharmX Corporation believes that non-GAAP measures have
limitations in that they do not reflect all of the amounts
associated with its results of operations as determined in
accordance with GAAP and that these measures should be considered
in addition to, not as a substitute for or in isolation from,
measures prepared in accordance with GAAP. BioPharmX
Corporation encourages investors and others to review the company's
financial information in its entirety and not rely on a single
financial measure.
In the first quarter of fiscal year 2016, BioPharmX Corporation
amended certain warrants resulting in a one-time charge. This
amount is excluded from its non-GAAP net loss available to common
shareholders and non-GAAP net loss available to common shareholders
per share because it is not reflective of ongoing operating results
in the period incurred.
Stock-based compensation expenses represent non-cash charges
related to equity awards granted by BioPharmX Corporation. Although
these are recurring charges to BioPharmX Corporation's operations,
management believes the measurement of these amounts can vary
considerably from period to period and depend substantially on
factors that are not a direct consequence of operating performance
that is within management's control. Thus, management believes that
excluding these charges from non-GAAP net loss available to common
shareholders and non-GAAP net loss available to common shareholders
per share facilitates comparisons of BioPharmX Corporation's
operational performance in different periods, as well as with
similarly determined non-GAAP financial measures of comparable
companies.
Amortization of purchased intangible assets results from the
purchase of a license related to molecular iodine technology.
These amounts are excluded from non-GAAP net loss available to
common shareholders and non-GAAP net loss available to common
shareholders per share because it is not reflective of ongoing
operating results in the period incurred.
Forward-Looking Statements
The information in this
press release contains forward-looking statements and information
within the meaning of Section 27A of the Securities Act of 1933, as
amended, or the Securities Act, and Section 21E of the Securities
Exchange Act of 1934, as amended, or the Exchange Act, which are
subject to the "safe harbor" created by those sections. This press
release contains forward-looking statements about the company's
expectations, plans, intentions, and strategies, including, but not
limited to, statements regarding the success of the
commercialization of VI2OLET iodine, the effectiveness
of BPX-01, the timing with respect to filing an IND and clinical
trials for BPX-01, the successful completion of multi-site IRB
studies for BPX-03; the successful advancement of the company's
product candidates and development pipeline, the expected use of
proceeds from the financing and the successful completion of the
private placement with Korea Investment Partners Overseas Expansion
Platform Fund. These forward-looking statements may be identified
by words such as "plan," "expect," "anticipate," "believe" or
similar expressions that are intended to identify such
forward-looking statements.
These forward looking statements involve risks and
uncertainties, as well as assumptions, which, if they do not fully
materialize or prove incorrect, could cause our results to differ
materially from those expressed or implied by such forward-looking
statements. The risks and uncertainties include those described in
the company's filings with the Securities and Exchange Commission,
including our quarterly report on Form 10-Q for the period ended
October 31, 2015. Given these risks
and uncertainties, you are cautioned not to place undue reliance on
such forward-looking statements. The forward-looking statements
included in this news release are made only as of the date hereof,
and the company undertakes no obligation to publicly update or
revise any forward-looking statements, whether as a result of new
information, future events or otherwise, except as may be required
under applicable securities law.
BioPharmX and Violet are registered trademarks of BioPharmX,
Inc.
---TABLES TO FOLLOW---
BIOPHARMX
CORPORATION
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
|
(in thousands,
except per share amounts; unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
|
|
|
October
31,
|
|
October
31,
|
|
|
|
|
2015
|
2014
|
|
2015
|
2014
|
|
|
|
|
|
|
|
|
|
Revenues,
net
|
$
20
|
$
-
|
|
$
29
|
$
-
|
Cost of goods
sold
|
19
|
-
|
|
38
|
-
|
Gross margin
(deficit)
|
1
|
-
|
|
(9)
|
-
|
|
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
|
Research and
development
|
1,649
|
664
|
|
3,866
|
1,827
|
|
Sales and
marketing
|
1,270
|
775
|
|
3,658
|
1,424
|
|
General and
administrative
|
930
|
753
|
|
3,074
|
2,016
|
|
|
Total operating
expenses
|
3,849
|
2,192
|
|
10,598
|
5,267
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(3,848)
|
(2,192)
|
|
(10,607)
|
(5,267)
|
|
Other income
(expense)
|
-
|
19
|
|
(436)
|
(17)
|
|
Loss before income
taxes
|
(3,848)
|
(2,173)
|
|
(11,043)
|
(5,284)
|
|
Provision for income
taxes
|
2
|
-
|
|
2
|
-
|
Net and
comprehensive loss
|
(3,850)
|
(2,173)
|
|
(11,045)
|
(5,284)
|
|
|
|
|
|
|
|
|
|
Accretion on Series A
convertible redeemable preferred stock
|
-
|
(39)
|
|
(202)
|
(66)
|
Deemed dividend on
Series A convertible redeemable preferred stock
|
-
|
(51)
|
|
(201)
|
(96)
|
Net loss available
to common stockholders
|
$
(3,850)
|
$ (2,263)
|
|
$ (11,448)
|
$ (5,446)
|
|
|
|
|
|
|
|
|
|
Net loss per
share
|
|
|
|
|
|
|
Basic and
diluted
|
($0.18)
|
($0.21)
|
|
($0.71)
|
($0.53)
|
Shares used in
computing net loss per share
|
|
|
|
|
|
|
Basic and
diluted
|
21,037
|
10,872
|
|
16,109
|
10,268
|
BIOPHARMX
CORPORATION
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(in thousands,
unaudited)
|
|
|
|
|
|
|
|
|
|
|
October
31,
|
January
31,
|
|
|
|
|
2015
|
2015
|
Assets
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
$
2,181
|
$ 1,305
|
|
|
Accounts
receivable
|
9
|
1
|
|
|
Inventories
|
336
|
160
|
|
|
Prepaid expenses and
other current assets
|
279
|
239
|
|
|
|
Total current
assets
|
2,805
|
1,705
|
|
|
|
|
|
|
|
Property and
equipment, net
|
224
|
234
|
|
Intangible assets,
net
|
127
|
149
|
|
Other
assets
|
85
|
85
|
|
|
|
Total
assets
|
$
3,241
|
$ 2,173
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity (Deficit)
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
$
1,761
|
$ 1,152
|
|
|
Accrued expenses and
other current liabilities
|
726
|
405
|
|
|
|
Total current
liabilities
|
2,487
|
1,557
|
|
|
|
|
|
|
|
Series A convertible
redeemable preferred stock
|
-
|
6,823
|
|
|
|
|
|
|
|
Stockholders' equity
(deficit)
|
754
|
(6,207)
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity (deficit)
|
$
3,241
|
$ 2,173
|
BIOPHARMX
CORPORATION
|
Reconciliation of
GAAP to Non-GAAP Net Loss and Net Loss Per Share Available to
Common Stockholders
|
(in thousands,
except per share amounts; unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
|
|
|
October
31,
|
|
October
31,
|
|
|
|
|
2015
|
2014
|
|
2015
|
2014
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss
available to common stockholders
|
$
(3,850)
|
$ (2,263)
|
|
$ (11,448)
|
$ (5,446)
|
|
|
|
|
|
|
|
|
|
|
|
Expense related to
modification of warrants
|
-
|
-
|
|
436
|
-
|
|
|
Amortization of
purchased intangible assets
|
7
|
-
|
|
22
|
-
|
|
|
Stock-based
compensation expense
|
|
|
|
|
|
|
|
-
|
Research and
development
|
38
|
54
|
|
163
|
131
|
|
|
-
|
Sales and
marketing
|
93
|
38
|
|
300
|
83
|
|
|
-
|
General and
administrative
|
111
|
225
|
|
403
|
429
|
|
|
|
Total stock-based
compensation expense
|
242
|
317
|
|
866
|
643
|
|
|
Total reconciling
items
|
249
|
317
|
|
1,324
|
643
|
|
Non-GAAP net loss
available to common stockholders
|
$
(3,601)
|
$ (1,946)
|
|
$ (10,124)
|
$ (4,803)
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss
available to common stockholders per share
|
$
(0.18)
|
$ (0.21)
|
|
$ (0.71)
|
$ (0.53)
|
|
|
Reconciling
items
|
|
|
|
|
|
|
|
-
|
Expense related to
modification of warrants
|
-
|
-
|
|
0.03
|
-
|
|
|
-
|
Amortization of
purchased intangible assets
|
-
|
-
|
|
-
|
-
|
|
|
-
|
Stock-based
compensation expense
|
0.01
|
0.03
|
|
0.05
|
0.06
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net loss
per share: basic and diluted
|
$
(0.17)
|
$ (0.18)
|
|
$ (0.63)
|
$ (0.47)
|
|
|
|
|
|
|
|
|
|
|
Shares used in
computing non-GAAP net loss per share
|
|
|
|
|
|
|
|
Basic and
diluted
|
21,037
|
10,872
|
|
16,109
|
10,268
|
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SOURCE BioPharmX Corporation