SAN JOSE, Calif., March 14, 2019 /PRNewswire/ -- BioPharmX
Corporation (NYSE American: BPMX), a specialty pharmaceutical
company focused on developing innovative medical dermatology
products, today reports financial results for the quarter and year
ended January 31, 2019.
Fiscal Year 2019 and Recent Business Highlights
- Initiated and completed enrollment for its
Phase 2b clinical trial of BPX-041, a novel
topical gel formulation of fully solubilized minocycline for the
treatment of papulopustular rosacea. The randomized, double-blind,
vehicle-controlled study enrolled 207 subjects with
moderate-to-severe papulopustular rosacea across 12 sites and is
evaluating the safety and efficacy of once daily application of
BPX-04, a 1% minocycline gel, versus a vehicle control over a
12-week treatment period. The study's primary endpoint is the mean
change in the number of facial inflammatory lesions from baseline
to week 12. The company anticipates announcing topline efficacy and
safety data from the study in July
2019.
- Strengthened the management team with the appointment of Dr.
David S. Tierney as president and
chief executive officer. Dr. Tierney has nearly 30 years of
executive leadership experience and a proven track record of
success with three NDA approvals, one PMA approval and three
successful company exits.
- Bolstered the board of directors with the appointments of Dr.
David S. Tierney and Dr. R.
Todd Plott. Dr. Plott is a
board-certified dermatologist with 30 years' experience, 16 years
of which were spent working as a research physician in the
pharmaceutical industry. He has been involved in nine prescription
drug development programs that received approval from the U.S. Food
and Drug Administration for products including SOLODYN™, ZIANA™ and
NORITATE™.
- Reduced operating costs by reducing its workforce by
approximately 40%, discontinuing non-core development programs,
divesting its women's health business and relocating its
headquarters to a lower-cost location in San Jose, California.
- Received notice that the U.S. Patent and Trademark Office
awarded patent protection for its novel tetracycline-class topical
drug composition. This patent protects tetracycline-class
antibiotics carried by BioPharmX's HyantX topical delivery system,
which, for the first time, stabilizes and fully solubilizes these
drugs to make them effective in a topical formulation.
- Received notice that the U.S. Food and Drug Administration
waived its requirement for a dermal carcinogenicity study for
BPX-01, eliminating several years of non-clinical research normally
required for FDA review.
- Entered into agreements with certain stockholders to amend
certain existing warrants to reduce the exercise price per share
and to issue new warrants, in exchange for the stockholders'
agreement to exercise their existing warrants for cash, resulting
in net proceeds to the company of $3.6
million.
- Requested and was granted an extension from the NYSE American
until April 30, 2019 to regain
compliance with the continued listing standards related to the
company's low stock price. Additionally, the company has until
September 24, 2019 to regain
compliance with certain NYSE American continued listing standards
related to the stockholders' equity requirements. As previously
stated, maintaining compliance with listing standards is of
paramount importance and the company is working with NYSE American
to restore full compliance.
"We met our primary objectives this quarter in completing the
enrollment of our BPX-04 Phase 2b
clinical trial, bolstering our board of directors and reducing our
operating costs," said Dr. Tierney, BioPharmX CEO. "The company has
and will continue to make the necessary changes to position the
company for long-term success and we look forward to informing our
shareholders as we make further progress."
Fourth Quarter Financial Results
For the fourth quarter ended January 31, 2019, total
operating expenses were $3.2 million, compared with total
operating expenses of $3.6 million in the prior fiscal
year's fourth quarter.
Net loss for the quarter ended January 31,
2019 was $4.1 million, or $0.02 per share,
compared with a net loss of $3.8 million, or $0.03 per
share, during the prior fiscal year's fourth quarter.
Excluding stock-based compensation expense, a charge related to
the modification of certain warrants and the impact of the change
in the fair value of the warrant liability, non-GAAP net loss for
the quarter ended January 31, 2019 was $2.9 million,
or $0.01 per share. During the fourth quarter of the
prior fiscal year, the comparable non-GAAP net loss was $3.4
million, or $0.03 per share.
Fiscal Year 2019 Financial Results
Total operating
expenses for the fiscal year ended January
31, 2019 were $16.5 million, compared
with $16.7 million in the prior fiscal year. The
decrease resulted primarily from lower headcount-related and
consulting expenses, partially offset by higher clinical trial and
product development costs related to BPX-04.
Net loss for the fiscal year was $17.3 million,
or $0.09 per share, compared with a net loss
of $16.6 million, or $0.19 per share, during the
prior fiscal year.
Excluding stock-based compensation expense, a charge related to
the modification of certain warrants and the impact of the change
in the fair value of the warrant liability, non-GAAP net loss for
the fiscal year ended January 31,
2019 was $14.4 million, or $0.07 per share.
In the prior fiscal year, the comparable non-GAAP net loss
was $15.0 million, or $0.17 per share.
Cash and cash equivalents, as of January 31, 2019,
were $3.1 million.
BioPharmX also disclosed, in its Annual Report on Form 10-K for
the fiscal year ended January 31, 2019, filed March 14,
2019 with the Securities and Exchange Commission, that its audited
financial statements contained an audit opinion from its
independent registered public accounting firm that included a going
concern paragraph. See further discussion in footnote 2 to
BioPharmX's consolidated financial statements included in its
Annual Report on Form 10-K. This announcement is made pursuant to
NYSE American Company Guide Section 610(b), which requires separate
public announcement of the receipt of an audit opinion containing a
going concern paragraph.
About BioPharmX® Corporation
BioPharmX Corporation
(NYSE American: BPMX) is a specialty pharmaceutical company focused
on developing prescription products utilizing its proprietary
HyantX Topical Delivery System for dermatology indications. To
learn more about BioPharmX, visit www.BioPharmX.com.
Use of Non-GAAP Measures
BioPharmX Corporation has
supplemented its financial information prepared in accordance with
generally accepted accounting principles in the United States ("GAAP") with non-GAAP
measures, including non-GAAP net loss and non-GAAP net loss per
share, which do not include stock-based compensation expense,
expense related to the modification of warrants and the impact of
changes in the fair value of the warrant liability. 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.
Stock-based compensation expense represents non-cash charges
related to equity awards granted by BioPharmX Corporation. In the
fourth quarter of fiscal year 2019 and in the third quarter of
fiscal year 2018, BioPharmX Corporation amended certain warrants
resulting in one-time charges. The change in the fair value of
the warrant liability results from the periodic revaluing of the
warrant liability. These amounts are excluded from the
company's non-GAAP net loss and non-GAAP net loss per share because
they are not reflective of ongoing operating results in the period
incurred. Although these may be 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 and non-GAAP net loss 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.
Forward-Looking Statement
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, and Section 21E of the Securities Exchange Act of 1934, as
amended, 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 the timing to complete
the Phase 2b study for BPX-04, the
commencement and results of future trials for BPX-04, level of
operating expenditures, the company's ability to obtain patent
protection and defend its intellectual property and the company's
ability to regain compliance with the NYSE American LLC's continued
listing standards and maintain its listing in the future.
Additional risks are set forth in our filings with the Securities
and Exchange Commission, including those described in the company's
Annual Report on Form 10-K for the fiscal year ended January 31, 2019. The forward-looking statements
included in this press release are made only as of the date hereof,
and the company undertakes no obligation to publicly update such
statements.
BioPharmX and HyantX are a registered trademarks of BioPharmX,
Inc.
1Caution: BPX-04 is a new drug limited by the U.S.
law to investigational use only.
--TABLES TO FOLLOW --
BIOPHARMX
CORPORATION
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
|
(in thousands,
except per share amounts; unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Twelve Months
Ended
|
|
|
|
|
January
31,
|
|
January
31,
|
|
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
|
Revenues,
net
|
|
$
5
|
|
$
19
|
|
$
57
|
|
$
73
|
Cost of goods
sold
|
3
|
|
222
|
|
83
|
|
250
|
Gross
margin
|
|
2
|
|
(203)
|
|
(26)
|
|
(177)
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
1,794
|
|
1,675
|
|
9,079
|
|
9,140
|
|
Sales and
marketing
|
440
|
|
486
|
|
2,157
|
|
2,415
|
|
General and
administrative
|
992
|
|
1,473
|
|
5,244
|
|
5,144
|
|
|
Total operating
expenses
|
3,226
|
|
3,634
|
|
16,480
|
|
16,699
|
|
Loss from
operations
|
(3,224)
|
|
(3,837)
|
|
(16,506)
|
|
(16,876)
|
|
Change in fair value
of warrant liability
|
29
|
|
34
|
|
28
|
|
364
|
|
Other income
(expense), net
|
(861)
|
|
16
|
|
(778)
|
|
(126)
|
|
Loss before provision
for income taxes
|
(4,056)
|
|
(3,787)
|
|
(17,256)
|
|
(16,638)
|
|
Provision for income
taxes
|
-
|
|
1
|
|
2
|
|
2
|
Net and
comprehensive loss
|
$
(4,056)
|
|
$
(3,788)
|
|
$
(17,258)
|
|
$
(16,640)
|
Net loss per
share
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
($0.02)
|
|
($0.03)
|
|
($0.09)
|
|
($0.19)
|
Shares used in
computing net loss per share
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
209,874
|
|
121,281
|
|
193,178
|
|
85,900
|
BIOPHARMX
CORPORATION
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(in thousands,
unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
January
31,
|
|
January
31,
|
|
|
|
|
2019
|
|
2018
|
Assets
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
$
3,069
|
|
$
7,576
|
|
|
Accounts receivable,
net
|
4
|
|
7
|
|
|
Prepaid expenses and
other current assets
|
312
|
|
398
|
|
|
|
Total current
assets
|
3,385
|
|
7,981
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
148
|
|
109
|
|
Other
assets
|
121
|
|
-
|
|
|
|
Total
assets
|
$
3,654
|
|
$
8,090
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts
payable
|
$
1,363
|
|
$
1,376
|
|
|
Accrued expenses and
other current liabilities
|
934
|
|
1,603
|
|
|
|
Total current
liabilities
|
2,297
|
|
2,979
|
|
Long-term
liabilities
|
59
|
|
39
|
|
|
|
Total
liabilities
|
2,356
|
|
3,018
|
|
|
|
|
|
|
|
|
Stockholders'
equity
|
1,298
|
|
5,072
|
|
|
|
Total liabilities and
stockholders' equity
|
$
3,654
|
|
$
8,090
|
BIOPHARMX
CORPORATION
|
Reconciliation of
GAAP Net Loss to Non-GAAP Net Loss
|
(in thousands,
except per share amounts; unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Twelve Months
Ended
|
|
|
|
|
January
31,
|
|
January
31,
|
|
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss
available to common stockholders
|
$
(4,056)
|
|
$
(3,788)
|
|
$
(17,258)
|
|
$
(16,640)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value
of warrant liability
|
(29)
|
|
(34)
|
|
(28)
|
|
(364)
|
|
|
Expense related to
modification of warrants
|
874
|
|
-
|
|
874
|
|
151
|
|
|
Stock-based
compensation expense:
|
|
|
|
|
|
|
|
|
|
-
|
Research and
development
|
129
|
|
148
|
|
654
|
|
545
|
|
|
-
|
Sales and
marketing
|
59
|
|
104
|
|
414
|
|
393
|
|
|
-
|
General and
administrative
|
116
|
|
219
|
|
993
|
|
949
|
|
|
|
Total stock-based
compensation expense
|
304
|
|
471
|
|
2,061
|
|
1,887
|
|
|
Total reconciling
items
|
1,149
|
|
437
|
|
2,907
|
|
1,674
|
|
Non-GAAP net loss
available to common stockholders
|
$
(2,907)
|
|
$
(3,351)
|
|
$
(14,351)
|
|
$
(14,966)
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss
available to common stockholders
|
$
(0.02)
|
|
$
(0.03)
|
|
$
(0.09)
|
|
$
(0.19)
|
|
|
Reconciling
items
|
|
|
|
|
|
|
|
|
|
-
|
Change in fair value
of warrant liability
|
-
|
|
-
|
|
-
|
|
-
|
|
|
-
|
Expense related to
modification of warrants
|
0.01
|
|
-
|
|
0.01
|
|
-
|
|
|
-
|
Stock-based
compensation expense
|
-
|
|
-
|
|
0.01
|
|
0.02
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net loss
per share: basic and diluted
|
$
(0.01)
|
|
$
(0.03)
|
|
$
(0.07)
|
|
$
(0.17)
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in
computing non-GAAP net loss per share
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
209,874
|
|
121,281
|
|
193,178
|
|
85,900
|
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SOURCE BioPharmX Corporation