BOSTON, Nov. 15, 2016 /PRNewswire/ -- Juniper
Pharmaceuticals, Inc. (Nasdaq: JNP) ("Juniper" or the "Company"), a
women's health therapeutics company, today announced financial
results for the three- and nine- month periods ended September 30, 2016. Recent highlights
include:
- OneCrinone® 90 mg (progesterone) launched in
Japan by Merck KGaA, Darmstadt,
Germany ("Merck KGaA");
- Completed pilot study for JNP-0101 intravaginal ring ("IVR")
demonstrating delivery of oxybutynin in an animal model;
- Discontinued development of COL-1077 lidocaine vaginal gel
following Phase 2b results;
- Revenue increased to $11.6
million for the third quarter of 2016 and $33.6 million for the first nine months of 2016,
up 5% and 13%, respectively, versus the prior year periods;
- Service revenues increased for the seventh consecutive quarter
on a local currency basis;
- Cash and equivalents of $15.0
million at September 30, 2016;
and,
- Monetized U.S. Crinone® (progesterone gel) royalty
stream with Allergan, Inc., providing $11
million of non-dilutive cash to Juniper in November
2016.
"Ongoing strong quarterly revenue growth provides continued cash
flow which, coupled with the $11
million from Allergan, enables targeted investments in
product development while also supporting our solid cash position,"
said Alicia Secor, Juniper's
President and CEO.
"We continue to advance our IVR pipeline, targeting unmet and
underserved needs in women's health including overactive bladder,
HRT and preterm birth," Ms. Secor continued. "We are selectively
evaluating acquisition and in-licensing opportunities with the goal
of bringing in one or more women's health therapeutics to enhance
our product portfolio and establish a new trajectory to support our
mission of building a leading women's health company."
Juniper's current 505(b)(2) product candidates are: JNP-0101, an
oxybutynin IVR for the treatment of overactive bladder in women;
JNP-0201, a combination estrogen + progesterone IVR for menopausal
symptoms; and, JNP-0301, a progesterone IVR for the prevention of
preterm birth in women with a short cervical length at
mid-pregnancy.
Third Quarter Financial Results
Third quarter total revenues increased 5% to $11.6 million, compared with $11.0 million for the quarter ended September 30, 2015.
Product revenues were $7.1
million, an increase of $0.3
million, or 5%, versus the third quarter of last year,
driven by continued in-market growth and new market sales of
Crinone® by Merck KGaA.
Service revenues were $3.3
million, a $0.1 million, or
4%, increase versus the third quarter of last year. While we
experienced continued strong revenue growth in the local UK
currency, the weak pound versus the U.S. dollar continues to dampen
translated revenue. On a local currency basis, third quarter
service revenues increased 22% year-over-year.
Royalty revenues, based on Allergan's sales of
Crinone® in the U.S., increased by $0.1 million to $1.2
million.
Gross profit increased to $5.9
million as compared with $4.4
million in the prior year quarter.
Total operating expenses were $5.7
million in the third quarter of 2016. The $1.5 million increase as compared to the prior
year quarter was driven by a $0.7
million increase in R&D spending and a $0.9 million increase in general and
administrative costs.
Third quarter R&D expense was driven by costs associated
with the now-concluded Phase 2 clinical trial of COL-1077. The
increase in general and administrative costs was primarily
driven by costs associated with organizational growth.
Juniper recorded net income of $0.2
million, or $0.02 per diluted
share, in the third quarter of 2016, compared to net income of
$0.4 million, or $0.03 per diluted share, in the same period of
2015.
Nine Months Financial Results
For the nine months ended September 30,
2016, total revenues increased 13% to $33.6 million, compared with $29.7 million for the nine months ended
September 30, 2015.
Product revenues were $20.7
million, an increase of $2.3
million, or 13%, versus the same period last year.
Service revenues were $10.0 million,
up $1.6 million, or 19%, versus the
same period last year. On a local currency basis, service revenues
in the first nine months of 2016 increased 31%
year-over-year. Royalty revenues increased by $0.1 million to $3.0
million.
Gross profit increased to $15.1
million as compared with $12.7
million in the same period last year.
Total operating expenses were $19.0
million in the nine months ended September 30, 2016. The $5.5 million increase as compared to the prior
year period was driven by a $3.1
million increase in R&D spending and a $2.5 million increase in general and
administrative costs.
Juniper recorded a net loss of $3.7
million, or ($0.34) per
diluted share, in the nine months ended September 30, 2016, compared to a net loss of
$0.5 million, or ($0.05) per diluted share, in the same period of
2015.
Liquidity
Cash and cash equivalents increased to $15.0 million as of September 30, 2016, versus $13.0 million at June 30,
2016 and $13.9 million at
December 31, 2015.
On November 15, 2016, the Company
announced the monetization of U.S. Crinone® royalty stream with
Allergan, Inc. Juniper will record the $11
million payment and royalties for the month of October as
royalty income in the fourth quarter of 2016.
Restatement
Financial results for prior periods discussed above are based on
the Company's restated financial results as filed on Forms 10-K/A
and 10-Q/A filed on November 14, 2016
with the SEC.
Under the revised methodology, product revenue is
recognized upon shipment to Merck KGaA at the minimum
price (our direct manufacturing cost plus 20%). Amounts
invoiced above the minimum price for countries where we are
entitled to a percentage of Merck KGaA's net revenue are recorded
as deferred revenue. Upon receiving sell-through information
from Merck KGaA, revenue is recorded to reflect the percentage of
Merck KGaA's net selling price for specific countries.
Conference Call
As previously announced, Juniper's management team will hold a
conference call to discuss financial results for the third quarter
ended September 30, 2016, as
follows:
Date:
|
Tuesday, November 15,
2016
|
Time:
|
8:30 a.m.
EST
|
Dial-in
numbers:
|
Toll free: (866)
374-4635 (U.S.), (855) 669-9657 (Canada), or
International: (412)
902-4218
|
Audio webcast (live
& archive):
|
www.juniperpharma.com, under 'Investors' or
click here
|
A replay of the teleconference will be available at
approximately one hour after completion through Monday, November 21, 2016, at (877) 344-7529
(U.S.), (855) 669-9658 (Canada) or
(412) 317-0088 (International). The conference ID for the replay is
10095855.
The archived webcast will be available for one year via the
aforementioned URLs.
About Juniper Pharmaceuticals
Juniper Pharmaceuticals, Inc. is focused on developing
therapeutics that address unmet medical needs in women's
health. The Company is advancing a pipeline of
proprietary product candidates that leverage its
differentiated intravaginal ring technology and the
505(b)(2) regulatory pathway. Juniper's core operating
business includes the Crinone® (progesterone gel)
franchise and Juniper Pharma Services, which provides high-end
fee-for-service pharmaceutical development and clinical trials
manufacturing to clients. Please
visit www.juniperpharma.com for more information.
Juniper Pharmaceuticals™ is a trademark of Juniper
Pharmaceuticals, Inc., in the U.S. and EU.
Crinone® is a registered trademark of Merck KGaA, Darmstadt,
Germany, outside the U.S. and of
Allergan, Inc. in the U.S.
OneCrinone® is a registered trademark of Merck KGaA,
Darmstadt, Germany.
Forward Looking Statements
This press release contains "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995, including statements relating to anticipated
future financial performance; the timing of clinical
trials for Juniper's product candidates and the announcement
of results from these trials; and the
potential of Juniper's IVR to improve the delivery of
therapeutics to women. Management believes that these
forward-looking statements are reasonable as and when made.
However, such forward-looking statements involve known and unknown
risks, uncertainties, and other factors that may cause actual
results to differ materially from those projected in the
forward-looking statements. These risks and uncertainties
include, but are not limited to: risks associated with
the drug development process generally, including the outcomes of
planned clinical trials and the regulatory review process; the risk
that the results of previously conducted studies involving our
product candidates will not be repeated or observed in ongoing or
future studies or following commercial launch, if such product
candidates are approved; risks associated with obtaining,
maintaining and protecting intellectual property; risks associated
with Juniper Pharmaceuticals' ability to enforce its patents
against infringers and defend its patent portfolio against
challenges from third parties; the risk of competition from
currently approved therapies and from other companies developing
products for similar uses; risk associated with Juniper
Pharmaceuticals' ability to manage operating expenses and/or obtain
additional funding to support its business activities; and risks
associated with Juniper Pharmaceuticals' dependence on third
parties. For a discussion of certain risks and uncertainties
associated with Juniper Pharmaceuticals'
forward-looking statements, please review the
Company's reports filed with the SEC, including, but not
limited to, its Annual Report on Form 10-K/A for the
period ended December 31, 2015 and Quarterly Report on
Form 10-Q for the period ended September 30, 2016 as filed with
the SEC on November 14, 2016. Readers
are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of
the date on which they are made. These statements are based on
management's current expectations and Juniper
Pharmaceuticals does not undertake any responsibility
to revise or update any forward-looking statements contained
herein, except as expressly required by law.
Contact
Amy Raskopf
Director, Corporate Communications, Juniper Pharmaceuticals,
Inc.
(917) 673-5775 / ir@juniperpharma.com
Media:
Amy Covino
Tell Med Strategies
(201) 774-3111 / amy.covino@tmstrat.com
To receive Juniper's press releases, SEC filings or calendar
alerts by email click here.
Follow us on LinkedIn
(tables follow)
Juniper
Pharmaceuticals, Inc.
Condensed
Consolidated Statements of Operations
(unaudited)
(in thousands, except
per share data)
|
|
|
Three Months Ended September
30,
|
|
Nine Months Ended September
30,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
As
Restated
|
|
|
As
Restated
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
Product
revenues
|
$
|
7,057
|
|
$
|
6,735
|
|
$
|
20,716
|
|
$
|
18,375
|
Service
revenues
|
|
3,337
|
|
|
3,218
|
|
|
9,964
|
|
|
8,392
|
Royalties
|
|
1,162
|
|
|
1,040
|
|
|
2,963
|
|
|
2,895
|
Total net
revenues
|
|
11,556
|
|
|
10,993
|
|
|
33,643
|
|
|
29,662
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product
revenues
|
|
3,683
|
|
|
4,192
|
|
|
11,892
|
|
|
10,825
|
Cost of service
revenues
|
|
2,022
|
|
|
2,361
|
|
|
6,630
|
|
|
6,176
|
Total cost of
revenues
|
|
5,705
|
|
|
6,553
|
|
|
18,522
|
|
|
17,001
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
profit
|
|
5,851
|
|
|
4,440
|
|
|
15,121
|
|
|
12,661
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
Sales and
marketing
|
|
259
|
|
|
338
|
|
|
910
|
|
|
941
|
Research and
development
|
|
2,304
|
|
|
1,598
|
|
|
8,234
|
|
|
5,114
|
General and
administrative
|
|
3,111
|
|
|
2,220
|
|
|
9,815
|
|
|
7,356
|
Total operating
expenses
|
|
5,674
|
|
|
4,156
|
|
|
18,959
|
|
|
13,411
|
|
|
|
|
|
|
Income (loss) from
operations
|
|
177
|
|
|
284
|
|
|
(3,838)
|
|
|
(750)
|
|
|
|
|
|
|
Interest expense,
net
|
|
(24)
|
|
|
(27)
|
|
|
(74)
|
|
|
(81)
|
Other income,
net
|
|
90
|
|
|
114
|
|
|
296
|
|
|
322
|
Income (loss)
before income taxes
|
|
243
|
|
|
371
|
|
|
(3,616)
|
|
|
(509)
|
(Benefit from)
provision for
income taxes
|
|
(5)
|
|
|
3
|
|
|
47
|
|
|
11
|
Net income
(loss)
|
$
|
248
|
|
$
|
368
|
|
$
|
(3,663)
|
|
$
|
(520)
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income
(loss) per share
|
$
|
0.02
|
|
$
|
0.03
|
|
$
|
(0.34)
|
|
$
|
(0.05)
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted weighted
average shares
outstanding
|
|
11,060
|
|
|
11,009
|
|
|
10,791
|
|
|
10,758
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income
(loss) per share
|
$
|
0.02
|
|
$
|
0.03
|
|
$
|
(0.34)
|
|
$
|
(0.05)
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic weighted average
shares
outstanding
|
|
10,799
|
|
|
10,771
|
|
|
10,791
|
|
|
10,758
|
|
|
|
|
|
|
|
|
|
|
|
|
Juniper
Pharmaceuticals, Inc.
Condensed
Consolidated Balance Sheets
(unaudited)
(in
thousands)
|
|
|
September
30,
|
|
December 31,
|
|
2016
|
|
2015
|
|
|
|
As
Restated
|
Assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
14,971
|
|
$
|
13,901
|
Accounts receivable,
net
|
|
5,255
|
|
|
7,538
|
Inventories
|
|
4,838
|
|
|
3,623
|
Prepaid expenses and
other current assets
|
|
1,346
|
|
|
872
|
|
|
|
|
|
|
Total current
assets
|
|
26,410
|
|
|
25,934
|
Property and
equipment, net
|
|
12,562
|
|
|
12,850
|
Intangible assets,
net
|
|
1,099
|
|
|
1,598
|
Goodwill
|
|
8,770
|
|
|
10,010
|
Other
assets
|
|
168
|
|
|
185
|
|
|
|
|
|
|
Total
Assets
|
$
|
49,009
|
|
$
|
50,577
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity:
|
|
|
|
|
|
Accounts
payable
|
$
|
4,778
|
|
$
|
2,004
|
Accrued expenses and
other
|
|
4,451
|
|
|
3,430
|
Deferred
revenue
|
|
5,810
|
|
|
4,167
|
Notes
payable
|
|
214
|
|
|
238
|
|
|
|
|
|
|
Total current
liabilities
|
|
15,253
|
|
|
9,839
|
Deferred revenue, net
of current portion
|
|
-
|
|
|
710
|
Notes payable, net of
current portion
|
|
2,370
|
|
|
2,897
|
Other noncurrent
liabilities
|
|
66
|
|
|
69
|
|
|
|
|
|
|
Total
Liabilities
|
|
17,689
|
|
|
13,515
|
|
|
|
|
|
|
Commitments and
Contingencies
|
|
|
|
|
|
Series C preferred
stock
|
|
550
|
|
|
550
|
|
|
|
Total stockholders'
equity
|
|
30,770
|
|
|
36,512
|
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
$
|
49,009
|
|
$
|
50,577
|
|
|
|
|
|
|
Logo - http://photos.prnewswire.com/prnh/20150527/218998LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/juniper-pharmaceuticals-reports-third-quarter-2016-financial-results-300362716.html
SOURCE Juniper Pharmaceuticals, Inc.