- Company appoints Beth Hecht to Board of Directors -
- Conference call scheduled for 8:30 a.m. ET today -
Neos Therapeutics, Inc. (NASDAQ: NEOS), a pharmaceutical company with a
late‐stage pipeline of innovative extended-release (XR) product
candidates for the treatment of attention deficit hyperactivity disorder
(ADHD), today announced financial results for the second quarter ended
June 30, 2015. The Company also announced the appointment of Beth Hecht
to its Board of Directors.
Recent Highlights
-
Completed an IPO of 5,520,000 shares of its common stock, including
the exercise in full by the underwriters of their overallotment
option, with gross proceeds of $82.8 million on July 28, 2015. Shares
are listed on the NASDAQ Global Market under the ticker NEOS.
-
Received FDA acknowledgement of the resubmission of the new drug
application (NDA) for NT-0202, the Company’s Amphetamine XR orally
disintegrating tablet (ODT), with a Prescription Drug User Fee Act
(PDUFA) goal date of January 27, 2016. This is the Company’s second
upcoming PDUFA goal date as the PDUFA goal date for its
Methylphenidate extended-release orally disintegrating tablet (now
provisionally called Cotempla XR-ODT™) is November 9, 2015.
-
Appointed Tom McDonnell as Chief Commercial Officer (announced prior
to IPO). Mr. McDonnell joined Neos after 10 years at Shire in various
roles, most recently as Vice President of US Marketing in the
Neuroscience Business Unit.
-
Appointed three new Board members: Beth Hecht (announced today) as
well as Paul Edick and John Schmid (announced prior to IPO).
“This has been a productive period for Neos Therapeutics, highlighted by
the completion of our IPO in July and listing of our shares on the
NASDAQ Global Market,” said Vipin K. Garg, Ph.D., President and CEO of
Neos. “The proceeds from our IPO provide us with the resources to
advance our three late-stage product candidates for the treatment of
ADHD. If approved, our two XR-ODT products would be the first
extended-release orally disintegrating tablets for once-daily treatment
of ADHD, representing a new patient-friendly therapeutic option for
patients of all ages.
“In addition to the positive business momentum we’ve achieved this
quarter, we are also continuing to add to our senior leadership team and
are pleased to welcome Beth Hecht to our Board of Directors. Beth brings
with her extensive life sciences experience, and we are confident that
she will be a valuable asset to the company going forward.”
Appointment of Beth Hecht to Board of Directors
Beth Hecht serves as Managing Director and Chief Legal and
Administrative Officer of Auven Therapeutics, a global private equity
firm with offices in the U.S., Bermuda, St. Thomas USVI and Switzerland
that acquires and develops pharmaceutical products that address unmet
medical needs. She has over twenty years of senior management experience
in the pharmaceutical and biotechnology industries, building and leading
legal, compliance and security teams at companies including Durata
Therapeutics Inc., MedPointe Inc., Warner Chilcott PLC, ChiRex, Ltd. and
Alpharma Inc. Ms. Hecht started her career as an attorney specializing
in corporate transactions and intellectual property at Willkie Farr &
Gallagher and then Kirkland & Ellis. Ms. Hecht received a J.D. from
Harvard Law School and a B.A. from Amherst College.
Select Financial Results for the Quarter Ended June 30, 2015
Total revenues were $1.5 million for the three months ended June 30,
2015, an increase of $1.4 million compared to the three months ended
June 30, 2014. All $1.5 million of product revenue in the three months
ended June 30, 2015 was generated from net sales of the company’s
generic Tussionex. Commercialization and profit rights for this product
were acquired in August 2014.
Cost of goods sold was $1.7 million for the three months ended June 30,
2015, an increase of $1.0 million compared to the three months ended
June 30, 2014. This increase was primarily due to a $600,000 increase in
raw material costs due to the increased sales of Tussionex, $200,000 of
amortization of the intangibles resulting from the acquisition of the
rights to commercialize and derive future profits from Tussionex ANDA
and a $200,000 increase in other costs related to Tussionex.
Research and development expenses were $2.1 million for the three months
ended June 30, 2015, a decrease of $1.1 million compared to the three
months ended June 30, 2014. The decrease was primarily due to a
$1.1 million reduction in clinical expense, primarily the result of the
completion of the Company’s classroom efficacy study of NT-0102 and the
completion of clinical trials for NT-0201 and NT-0202 in 2014.
Selling, general & administrative expenses were $2.3 million for the
three months ended June 30, 2015, an increase of $0.9 million from the
$1.4 million for the three months ended June 30, 2014. The increase was
primarily due to pre-commercialization activities for the NT-0102 and
NT-0202 product candidates and increased salary expenses associated with
the building out of the commercial team.
The Company reported a net loss of $5.8 million in the three months
ended June 30, 2015 compared with $5.6 million for the same period in
2014.
At June 30, 2015, the company's cash, cash equivalents and investments
amounted to $25.6 million. This amount does not include the net proceeds
from the Company's initial public offering, which closed on July 28,
2015. The net proceeds from this offering, after deducting underwriting
discounts and commissions and other offering expenses payable by us,
were approximately $75.0 million.
Conference Call Details
Neos Therapeutics will host a conference call at 8:30 a.m. ET today to
discuss the Company’s 2015 second quarter financial results. To access
the call, dial 866-842-7969 (U.S.) or 704-908-0466 (outside of the
U.S.). The Conference ID is 19474416. A live webcast will be available
on the Investor Relations page of the company’s website at http://investors.neostx.com/.
Please log in approximately 5-10 minutes prior to the scheduled start
time.
The archived webcast will be available on the company’s Investor
Relations page under Presentations.
About Neos Therapeutics
Neos Therapeutics, Inc. is a pharmaceutical company focused on
developing, manufacturing and commercializing products utilizing its
proprietary modified‐release drug delivery technology platform. The
Company is initially focusing on ADHD and has developed three branded
product candidates that are XR medications in patient‐friendly orally
disintegrating tables (“ODT”) or liquid suspension dosage forms. In
addition, Neos manufactures and markets its generic equivalent of the
branded product Tussionex®1, an XR liquid suspension of
hydrocodone and chlorpheniramine indicated for the relief of cough and
upper respiratory symptoms of a cold.
Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements concerning the PDUFA dates for Cotempla XR-ODT™ and
NT-0202 and capabilities of our two XR-ODT products. Forward-looking
statements generally relate to future events or our future financial or
operating performance. In some cases, you can identify forward-looking
statements because they contain words such as "may," "will," "should,"
"expects," "plans," "anticipates," "could," "intends," "target,"
"projects," "contemplates," "believes," "estimates," "predicts,"
"potential" or "continue" or the negative of these words or other
similar terms or expressions that concern our expectations, strategy,
plans, prospects or intentions. These forward-looking statements
reflect our current views about our expectations, strategy, plans,
prospects or intentions, which are based on the information currently
available to us and on assumptions we have made. Although we believe
that our plans, intentions, expectations, strategies and prospects as
reflected in or suggested by those forward-looking statements are
reasonable, we can give no assurance that the plans, intentions,
expectations or strategies will be attained or achieved. Furthermore,
actual results may differ materially from those described in the
forward-looking statements and will be affected by a variety of risks
and factors that are beyond our control including, without limitation,
the receipt of regulatory approval for our product candidates, our
ability to market and sell our product candidates, and other risks set
forth under the caption “Risk Factors” in our final prospectus filed on
July 24, 2015 pursuant to Rule 424(b) of the Securities Act of 1933, as
amended, as updated by our subsequently filed Quarterly Reports on Form
10-Q and our other SEC filings. We assume no obligation to update any
forward-looking statements contained in this document as a result of new
information, future events or otherwise.
1 Tussionex® is a registered trademark of the UCB Group of
Companies
Financial Tables Follow
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neos Therapeutics, Inc. and Subsidiaries
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
In thousands, except per share data
|
|
|
2015
|
|
|
2014
|
ASSETS
|
|
|
(unaudited)
|
|
|
|
Current assets:
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
$
|
25,631
|
|
|
|
$
|
13,343
|
|
Short term investments
|
|
|
|
-
|
|
|
|
|
3,000
|
|
Accounts receivable, net of allowances of $2,579 and $204,
respectively
|
|
|
|
2,096
|
|
|
|
|
367
|
|
Inventories
|
|
|
|
1,703
|
|
|
|
|
2,031
|
|
Other current assets
|
|
|
|
235
|
|
|
|
|
264
|
|
Total current assets
|
|
|
|
29,665
|
|
|
|
|
19,005
|
|
Property and equipment, net
|
|
|
|
5,334
|
|
|
|
|
5,831
|
|
Intangible Assets, net
|
|
|
|
17,420
|
|
|
|
|
18,167
|
|
Other Assets
|
|
|
|
3,471
|
|
|
|
|
2,227
|
|
Total assets
|
|
|
$
|
55,890
|
|
|
|
$
|
45,230
|
|
LIABILITIES, REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT
|
|
|
|
|
|
|
Current Liabilities:
|
|
|
|
|
|
|
Accounts payable
|
|
|
$
|
1,333
|
|
|
|
$
|
1,257
|
|
Accrued expenses
|
|
|
|
2,430
|
|
|
|
|
2,715
|
|
Current portion of long-term debt
|
|
|
|
3,257
|
|
|
|
|
1,653
|
|
Total current liabilities
|
|
|
|
7,020
|
|
|
|
|
5,625
|
|
Long-Term Liabilities:
|
|
|
|
|
|
|
Long-term debt, net of current portion
|
|
|
|
31,198
|
|
|
|
|
23,121
|
|
Earnout liability
|
|
|
|
356
|
|
|
|
|
756
|
|
Deferred gain on leaseback
|
|
|
|
967
|
|
|
|
|
1,383
|
|
Deferred rent
|
|
|
|
1,172
|
|
|
|
|
1,189
|
|
Warrant liabilities
|
|
|
|
3,934
|
|
|
|
|
1,789
|
|
Total long-term liabilities
|
|
|
|
37,627
|
|
|
|
|
28,238
|
|
Redeemable Preferred Stock, $0.001 par value
|
|
|
|
|
|
|
Series A – 1,170,000 authorized; issued and outstanding; liquidation
preference of $5,850 as of June 30, 2015 and at December 31, 2014
|
|
|
|
1,068
|
|
|
|
|
1,068
|
|
Series B – 4,000,000 authorized; 3,113,099 issued and outstanding;
liquidation preference of $15,565 as of June 30, 2015 and at
December 31, 2014
|
|
|
|
14,730
|
|
|
|
|
14,559
|
|
Series B-1 – 8,830,000 authorized; 5,461,802 issued and outstanding;
liquidation preference of $62,731 as of June 30, 2015 and at
December 31, 2014
|
|
|
|
33,803
|
|
|
|
|
32,391
|
|
Series C – 13,500,000 authorized; 11,528,483 issued and outstanding
as of June 30, 2015 and 8,753,547 issued and outstanding at December
31, 2014; liquidation preference of $57,642 as of June 30, 2015 and
$43,768 at December 31, 2014
|
|
|
|
54,648
|
|
|
|
|
42,131
|
|
|
|
|
|
104,249
|
|
|
|
|
90,149
|
|
Stockholders’ Deficit:
|
|
|
|
|
|
|
Common stock, $0.001 par value, 35,000,000 authorized; 887,414
issued and outstanding as of June 30, 2015 and 938,859 and 882,954
issued and outstanding at December 31, 2014, respectively
|
|
|
|
1
|
|
|
|
|
1
|
|
Additional paid-in capital
|
|
|
|
5,069
|
|
|
|
|
4,831
|
|
Accumulated deficit
|
|
|
|
(98,076
|
)
|
|
|
|
(83,614
|
)
|
Total stockholders' deficit
|
|
|
|
(93,006
|
)
|
|
|
|
(78,782
|
)
|
Total liabilities, redeemable preferred stock and stockholders’
deficit
|
|
|
$
|
55,890
|
|
|
|
$
|
45,230
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neos Therapeutics, Inc. and Subsidiaries
|
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|
(UNAUDITED)
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
In thousands, except share and per share amounts
|
|
|
2015
|
|
|
2014
|
|
|
2015
|
|
|
2014
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
|
|
|
$
|
1,484
|
|
|
|
$
|
—
|
|
|
|
$
|
1,912
|
|
|
|
$
|
—
|
|
Manufacturing
|
|
|
|
—
|
|
|
|
|
0
|
|
|
|
|
—
|
|
|
|
|
113
|
|
Development
|
|
|
|
—
|
|
|
|
|
25
|
|
|
|
|
—
|
|
|
|
|
93
|
|
Profit Sharing
|
|
|
|
—
|
|
|
|
|
30
|
|
|
|
|
—
|
|
|
|
|
141
|
|
|
|
|
|
1,484
|
|
|
|
|
55
|
|
|
|
|
1,912
|
|
|
|
|
347
|
|
Cost of Goods Sold
|
|
|
|
1,659
|
|
|
|
|
638
|
|
|
|
|
2,754
|
|
|
|
|
1,443
|
|
Gross loss
|
|
|
|
(175
|
)
|
|
|
|
(583
|
)
|
|
|
|
(842
|
)
|
|
|
|
(1,096
|
)
|
Research and Development
|
|
|
|
2,102
|
|
|
|
|
3,183
|
|
|
|
|
6,422
|
|
|
|
|
5,468
|
|
Selling and Marketing Expenses
|
|
|
|
602
|
|
|
|
|
8
|
|
|
|
|
928
|
|
|
|
|
11
|
|
General and Administrative Expenses
|
|
|
|
1,659
|
|
|
|
|
1,404
|
|
|
|
|
2,996
|
|
|
|
|
2,951
|
|
Loss from operations
|
|
|
|
(4,538
|
)
|
|
|
|
(5,178
|
)
|
|
|
|
(11,188
|
)
|
|
|
|
(9,526
|
)
|
Interest Expense, net
|
|
|
|
(884
|
)
|
|
|
|
(618
|
)
|
|
|
|
(1,641
|
)
|
|
|
|
(1,637
|
)
|
Other Income, net
|
|
|
|
208
|
|
|
|
|
208
|
|
|
|
|
415
|
|
|
|
|
410
|
|
Change in fair value of earnout and warrant liabilities
|
|
|
|
(539
|
)
|
|
|
|
—
|
|
|
|
|
105
|
|
|
|
|
—
|
|
Net loss
|
|
|
$
|
(5,753
|
)
|
|
|
$
|
(5,588
|
)
|
|
|
$
|
(12,309
|
)
|
|
|
$
|
(10,753
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
(5,753
|
)
|
|
|
|
(5,588
|
)
|
|
|
|
(12,309
|
)
|
|
|
|
(10,753
|
)
|
Preferred Stock Accretion to Redemption Value
|
|
|
|
(586
|
)
|
|
|
|
(265
|
)
|
|
|
|
(1,070
|
)
|
|
|
|
(582
|
)
|
Preferred Stock Dividends
|
|
|
|
(544
|
)
|
|
|
|
(544
|
)
|
|
|
|
(1,083
|
)
|
|
|
|
(1,083
|
)
|
Net loss attributable to common stock
|
|
|
$
|
(6,883
|
)
|
|
|
$
|
(6,397
|
)
|
|
|
$
|
(14,462
|
)
|
|
|
$
|
(12,418
|
)
|
Weighted average common shares outstanding used to compute net loss
per share, basic and diluted
|
|
|
|
887,397
|
|
|
|
|
873,060
|
|
|
|
|
886,323
|
|
|
|
|
872,176
|
|
Net loss per share attributable to common stock, basic and diluted
|
|
|
$
|
(7.76
|
)
|
|
|
$
|
(7.33
|
)
|
|
|
$
|
(16.32
|
)
|
|
|
$
|
(14.24
|
)
|
![](http://cts.businesswire.com/ct/CT?id=bwnews&sty=20150903005294r1&sid=ntxv4&distro=nx&lang=en)
View source version on businesswire.com: http://www.businesswire.com/news/home/20150903005294/en/
Copyright Business Wire 2015