Neos Therapeutics Reports First Quarter 2017 Financial Results
May 09 2017 - 7:00AM
Neos Therapeutics, Inc. (NASDAQ:NEOS), a pharmaceutical company
focused on developing, manufacturing and commercializing innovative
extended-release (XR) products using its proprietary
modified-release drug delivery and orally disintegrating tablet
(ODT) technology platforms, today reported financial results for
the first quarter ended March 31, 2017 and provided a business
update.
“The first year of launch for Adzenys XR-ODT™
continues to be successful and in fact, the numbers show that
during the first quarter of 2017, we reached more than 32,000
quarterly prescriptions and more than 13,000 monthly prescriptions
for the first time,” said Vipin K. Garg, Ph.D., President and CEO
of Neos Therapeutics. “Given the positive physician and patient
feedback and continually increasing prescription numbers for
Adzenys XR-ODT, we hope to achieve a similar success with the
anticipated launch of Cotempla XR-ODT™, our methylphenidate
extended-release ODT product, this fall. We expect to use our
current infrastructure and salesforce to launch Cotempla XR-ODT as
well as our other product candidate, NT-0201, our amphetamine XR
liquid suspension, if they are approved.”
Commercial Highlights for Adzenys
XR-ODT™
- Becoming a Leading Alternative Dosage Form for
ADHD: In less than one year on the market, Adzenys XR-ODT™
has become the second most prescribed alternative dosage form
product for the treatment of ADHD.
- Prescriptions Continue to Show Strong Growth:
Since the launch in May 2016 through March 31, 2017, Adzenys XR-
ODT™ continued to perform well and the cumulative total number of
prescriptions filled for Adzenys XR-ODT, as reported by IMS, were
62,635, including 32,296 for the three months ended March 31, 2017.
Monthly prescriptions increased approximately 20% per month during
the three months ended March 31, 2017. As of April 28, 2017, the
cumulative total number of prescriptions filled for Adzenys XR-ODT,
as reported by IMS, were 75,320.
- Number of Prescribers Continues to Increase:
The number of prescribers of Adzenys XR-ODT continued to grow since
launch and as of March 31, 2017, 5,986 health care providers had
written prescriptions for the product. As of April 14, 2017, that
number had increased to 6,249.
- Patients are Switching to Adzenys XR-ODT:
Patients switching from another ADHD medication accounted for
approximately 74% of all new Adzenys XR-ODT prescriptions, as
reported by IMS, as of the week ended April 21, 2017.
- Strong Adoptions Across all Patient Types: As
of the week ended April 21, 2017, as reported by IMS, 61% of all
new Adzenys XR-ODT prescriptions were for pediatric patients and
39% were for adult patients, indicating a broad appeal of Adzenys
XR-ODT in all patient types.
Key
Recent Accomplishments and Anticipated Milestones for
2017
- In February 2017, the Company announced the pricing of an
underwritten public offering of 5,000,000 shares of its common
stock at a public offering price of $5.00 per share, before
underwriting discounts and commissions. The underwriters for this
offering elected to exercise in full their option to purchase an
additional 750,000 shares of common stock at the public offering
price, less the underwriting discounts and commissions. Net
proceeds from this offering were approximately $26.7 million.
During the same month, the Company closed on a capital lease line
of up to $5 million to finance its capital expenditures for the
2017 fiscal year.
- A New Drug Application (NDA) for Cotempla XR-ODT, the Company’s
methylphenidate extended-release ODT product, is currently under
review at the U.S. Food and Drug Administration (FDA) and its
Prescription Drug User Fee Act (PDUFA) goal date is June 19, 2017.
If approved, the Company anticipates a launch in the fall of
2017.
- A second NDA is also under review for NT-0201, the Company’s
amphetamine XR liquid suspension product candidate and its PDUFA
goal date is September 15, 2017. If approved, the Company
anticipates a launch of this product in January 2018.
Select Financial Results for the First
Quarter Ended March 31, 2017
- Total product revenues were $5.6 million for the three months
ended March 31, 2017, compared to $2.6 million for the same period
in 2016. This includes product revenue associated with
dispensed patient prescriptions of Adzenys XR-ODT of $3.1 million
and $2.5 million in net sales for generic Tussionex.
- Cost of goods sold for the three months ended March 31, 2017
was $4.6 million, compared to $2.7 million for the same period of
2016. The increase was due to increased sales of Adzenys
XR-ODT.
- Research and development expenses for the three months ended
March 31, 2017 were $1.7 million, compared to $2.0 million for the
same period in 2016.
- Selling and marketing expenses were $10.7 million for the three
months ended March 31, 2017, compared to $6.4 million for the same
period in 2016. The increased expense was due to commercial sales
organization and other selling costs associated with the
commercialization of Adzenys XR-ODT, which launched in May
2016.
- General and administrative expenses for the three months ended
March 31, 2017 were $3.5 million, compared to $3.3 million for the
same period in 2016.
- The Company reported a net loss of $17.1 million in the three
months ended March 31, 2017, compared to $12.6 million for the same
period in 2016.
- At March 31, 2017, the Company held $43.7 million in cash and
cash equivalents and $10.6 million in short-term investments.
Conference Call Details Neos
management will host a conference call and live audio webcast to
discuss results and provide a company update at 8:30 a.m. ET today.
The live call may be accessed by dialing (877) 388-8985 for
domestic calls, or +1 (562) 912-2654 for international callers, and
referencing conference ID number 94755525. A live audio
webcast for the conference call will be available on the Investor
Relations page of the Company’s website at
http://investors.neostx.com/.
About Neos TherapeuticsNeos
Therapeutics, Inc. is a pharmaceutical company focused on
developing, manufacturing and commercializing products utilizing
its proprietary modified-release drug delivery technology
platforms. Adzenys XR-ODT™, indicated for the treatment of ADHD in
patients 6 years of age and older, is the first approved product
using the Company’s extended-release (XR)-orally disintegrating
tablet (ODT) technology platform. Neos, which is initially focusing
on the treatment of ADHD, has filed New Drug Applications with the
U.S. Food and Drug Administration for two other branded product
candidates that are XR medications in ODT or oral suspension dosage
forms. In addition, Neos manufactures and markets its generic
equivalent of the branded product Tussionex®, an XR oral suspension
of hydrocodone and chlorpheniramine indicated for the relief of
cough and upper respiratory symptoms of a cold.1
1Tussionex® is a registered trademark of the UCB Group of
Companies.
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 commercialization of
Adzenys XR-ODTTM, the regulatory submissions, including PDUFA
review periods and approvals, marketing plans and timing and the
therapeutic potential of Cotempla XR-ODT and NT-0201.
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 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, our ability to successfully obtain regulatory approval
of our Cotempla XR-ODT and NT-0201 product candidates, the
timing of such approval, our ability to market and sell our
product candidates and other risks set forth under the
caption “Risk Factors” in our most recently filed Annual Report on
Form 10-K as updated by our subsequently filed
other SEC filings, including our Quarterly
Report(s) on Form 10-Q. We assume no obligation to update
any forward-looking statements contained in this document as a
result of new information, future events or otherwise.
Neos Therapeutics, Inc. and
Subsidiaries |
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) |
(In thousands, except share and per share data) |
|
|
|
March 31, |
|
December 31, |
|
|
|
2017 |
|
2016 |
|
ASSETS |
|
|
|
|
|
Current Assets: |
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
43,661 |
|
|
$ |
24,352 |
|
|
Short-term investments |
|
10,571 |
|
|
15,430 |
|
|
Accounts
receivable, net of allowances for chargebacks and cash discounts of
$2,371 and $950, respectively |
|
11,852 |
|
|
6,135 |
|
|
Inventories |
|
5,592 |
|
|
5,767 |
|
|
Deferred
contract sales organization fees |
|
623 |
|
|
720 |
|
|
Other
current assets |
|
2,356 |
|
|
2,865 |
|
|
Total current assets |
|
74,655 |
|
|
55,269 |
|
|
|
|
|
|
|
|
Property and equipment,
net |
|
6,953 |
|
|
7,076 |
|
|
Intangible assets,
net |
|
15,189 |
|
|
15,579 |
|
|
Other assets |
|
2,219 |
|
|
2,218 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
99,016 |
|
|
$ |
80,142 |
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY (DEFICIT) |
|
|
|
|
|
|
|
|
|
|
|
Current
Liabilities: |
|
|
|
|
|
Accounts
payable |
|
$ |
6,985 |
|
|
$ |
7,798 |
|
|
Accrued
expenses |
|
7,065 |
|
|
5,264 |
|
|
Deferred
revenue |
|
4,933 |
|
|
3,662 |
|
|
Current
portion of long-term debt |
|
6,996 |
|
|
4,921 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
25,979 |
|
|
21,645 |
|
|
|
|
|
|
|
|
Long-Term
Liabilities: |
|
|
|
|
|
Long-term
debt, net of current portion |
|
59,010 |
|
|
58,599 |
|
|
Deferred
rent |
|
1,151 |
|
|
1,174 |
|
|
Other
long-term liabilities |
|
266 |
|
|
272 |
|
|
|
|
|
|
|
|
Total long-term liabilities |
|
60,427 |
|
|
60,045 |
|
|
|
|
|
|
|
|
Stockholders’ Equity
(Deficit): |
|
|
|
|
|
Preferred
stock, $0.001 par value, 5,000,000 shares authorized, no shares
issued or outstanding at March 31, 2017 and December 31,
2016 |
|
— |
|
|
— |
|
|
Common
stock, $0.001 par value, 100,000,000 authorized at March 31, 2017
and December 31, 2016; 22,579,541 and 22,560,635 issued and
outstanding at March 31, 2017, respectively; 16,079,902 and
16,060,996 issued and outstanding at December 31, 2016,
respectively |
|
23 |
|
|
16 |
|
|
Treasury
stock, at cost, 18,906 shares at March 31, 2017 and
December 31, 2016 |
|
(232 |
) |
|
(232 |
) |
|
Additional paid-in capital |
|
230,030 |
|
|
198,787 |
|
|
Accumulated deficit |
|
(217,208 |
) |
|
(200,118 |
) |
|
Accumulated other comprehensive loss |
|
(3 |
) |
|
(1 |
) |
|
|
|
|
|
|
|
Total stockholders’ equity (deficit) |
|
12,610 |
|
|
(1,548 |
) |
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity |
|
$ |
99,016 |
|
|
$ |
80,142 |
|
|
Neos Therapeutics, Inc. and
Subsidiaries |
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED) |
|
(In thousands, except share and per share data) |
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
2017 |
|
|
2016 |
|
|
|
Revenues: |
|
|
|
|
|
|
|
Net
product sales |
|
$ |
5,627 |
|
|
$ |
2,583 |
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
4,615 |
|
|
2,756 |
|
|
|
Gross profit (loss) |
|
1,012 |
|
|
(173 |
) |
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
1,724 |
|
|
1,977 |
|
|
|
Selling and marketing
expenses |
|
10,706 |
|
|
6,424 |
|
|
|
General and
administrative expenses |
|
3,539 |
|
|
3,291 |
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(14,957 |
) |
|
(11,865 |
) |
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
(2,211 |
) |
|
(1,012 |
) |
|
|
Other income, net |
|
78 |
|
|
263 |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(17,090 |
) |
|
$ |
(12,614 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding used to compute net loss per share, basic and
diluted |
|
19,624,712 |
|
|
16,025,318 |
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share of common stock, basic and diluted |
|
$ |
(0.87 |
) |
|
$ |
(0.79 |
) |
|
|
Contacts:
Richard Eisenstadt
Chief Financial Officer
Neos Therapeutics
(972) 408-1389
reisenstadt@neostx.com
Sarah McCabe
Stern Investor Relations, Inc.
(212) 362-1200
sarah@sternir.com
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