Neos Therapeutics Reports Third Quarter 2016 Financial Results
November 10 2016 - 7:00AM
Neos Therapeutics, Inc. (NASDAQ:NEOS), a pharmaceutical company
focused on developing, manufacturing and commercializing innovative
extended-release (XR) products for the treatment of
attention-deficit/hyperactivity disorder (ADHD), today reported
financial results for the third quarter ended September 30, 2016
and provided a business update.
“Adzenys XR-ODT™ has been performing very well
since our launch in May 2016, as demonstrated by the prescription
growth reported by IMS. We are seeing product adoption across both
pediatric and adult patient populations and the feedback from
physicians and patients continues to be positive,” said Vipin K.
Garg, Ph.D., President and CEO of Neos Therapeutics. “We also
remain on track to resubmit the NDA for Cotempla XR-ODT™, our
extended-release methylphenidate ODT product, and to submit the NDA
for NT-0201, our extended-release amphetamine liquid suspension, in
the fourth quarter of 2016. If approved, we anticipate the launch
of both these products during the second half of 2017.”
Adzenys XR-ODT™ Launch
Update
- For the three months ended September 30, 2016, total
prescriptions filled for Adzenys XR-ODT, as reported by IMS, were
8,959. For the four-week period ending October 28, 2016, IMS
reported an additional 5,177 prescriptions filled for Adzenys
XR-ODT.
- Since the launch in May 2016 through October 28, 2016, the
cumulative total number of prescriptions filled, as reported by
IMS, were 15,186.
- Weekly prescriptions increased approximately 13% per week
during the three months ended September 30, 2016.
- Patients switching from another ADHD medication accounted for
approximately 75% of all new Adzenys XR-ODT prescriptions, as
reported by IMS.
- As of the week ended October 21, 2016, as reported by IMS, 62%
of all new Adzenys XR-ODT prescriptions were for pediatric patients
and 38% were for adult patients, indicating a broad appeal of
Adzenys XR-ODT in all patient types.
- The number of new prescribers has continued to grow since
launch. The cumulative total number of prescribers of Adzenys
XR-ODT, as reported by IMS through the week ended October 21, 2016,
was 2,887.
- Managed care coverage for Adzenys XR-ODT has increased to 83%
of lives covered by commercial payers compared to 70% covered lives
in the last quarter.
Anticipated Milestones for Other
Pipeline Product Candidates
- Resubmit the New Drug Application (NDA) for Cotempla XR-ODT,
the Company’s methylphenidate extended-release ODT product, in the
fourth quarter of 2016.
- Submit the NDA for NT-0201, the Company’s amphetamine XR liquid
suspension, in the fourth quarter of 2016.
Select Financial Results for the Third
Quarter Ended September 30, 2016
- Total product revenues were $1.6 million for the three months
ended September 30, 2016, compared to $0.2 million for the same
period in 2015. Adzenys XR-ODT revenues were approximately $0.7
million, and the remainder of the increase is attributed to an
increase in sales of the Company’s generic Tussionex.
- Gross loss for the three months ended September 30, 2016 was
$0.7 million, compared to $1.0 million for the same period of 2015.
This improvement was due to increased revenue offset by the cost of
goods for the increased volume of product sales.
- Research and development expenses for the three months ended
September 30, 2016 were $2.9 million, compared to $2.7 million for
the same period in 2015. This increase was primarily due to
completion of the bioequivalence studies for Cotempla XR-ODT and
NT-0201.
- Selling and marketing expenses were $17.0 million for the three
months ended September 30, 2016, compared to $1.4 million for the
same period in 2015. The increase is primarily directly
attributable to the commercialization of Adzenys XR-ODT, which
launched in May 2016.
- General and administrative expenses for the three months ended
September 30, 2016 were $3.1 million, compared to $2.0 million for
the same period in 2015. This increase was a result of higher
professional fees and salary and compensation expenses associated
with becoming a public reporting and commercial company.
- The Company reported a net loss of $25.8 million in the three
months ended September 30, 2016, compared to $9.4 million for the
same period in 2015.
- At September 30, 2016, the Company’s cash, cash equivalents and
short-term investments amounted to $60.0 million.
Upcoming Events and
Presentations
- Global Mizuho Investor Conference, New York City, November
14th
- Stifel 2016 Healthcare Conference, New York City, November
15th
- BMO Capital Markets Prescriptions for Success Healthcare
Conference, New York City, December 14th
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,
November 10, 2016. 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 5573407. 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 Therapeutics
Neos Therapeutics, Inc. is a pharmaceutical
company focused on developing, manufacturing and commercializing
products utilizing its proprietary modified‐release drug delivery
technology platforms. Adzenys XR-ODTTM, indicated for the treatment
of ADHD, is the first approved product using the Company’s XR-ODT
technology platform. Neos, which is initially focusing on the
treatment of ADHD, has two other branded product candidates that
are XR medications in 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.
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 resubmission of the NDA for Cotempla
XR-ODTTM, the submission of the NDA for NT‑0201, the commercial
launch of Cotempla XR-ODTTM and NT-0201, and the Company’s upcoming
events and presentations. 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, our ability to successfully
launch Adzenys XR-ODTTM, market acceptance by physicians, patients,
third-party payors and the medical community, our ability to
successfully address the deficiencies identified by
the FDA or which may be identified by
the FDA which preclude approval of the NDA for our
Cotempla XR-ODTTM product candidate, including that we
demonstrate bioequivalence between the clinical trial material and
to-be-marketed drug product and that we assess the food effect on
the to-be-marketed drug product, the receipt of regulatory approval
for Cotempla XR-ODTTM and NT-0201, our ability to market and
sell our product candidates, our ability to raise capital when
needed and other risks set forth under the caption “Risk Factors”
in our most recent Quarterly Report on Form 10-Q, as updated by our
other subsequently filed 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.
|
Neos Therapeutics, Inc. and
SubsidiariesCONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED) |
|
In
thousands, except share and per share data |
September 30, 2016 |
|
|
|
December 31, 2015 |
|
|
ASSETS |
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
|
43,489 |
|
|
|
$ |
|
90,763 |
|
|
Short-term investments |
|
|
16,547 |
|
|
|
|
|
- |
|
|
Accounts
receivable, net of allowances of $1,193 and $1,039,
respectively |
|
|
4,263 |
|
|
|
|
|
3,903 |
|
|
Inventories |
|
|
5,683 |
|
|
|
|
|
2,520 |
|
|
Other
current assets |
|
|
1,980 |
|
|
|
|
|
1,058 |
|
|
Total current assets |
|
|
71,962 |
|
|
|
|
|
98,244 |
|
|
Property and equipment,
net |
|
|
6,952 |
|
|
|
|
|
5,124 |
|
|
Intangible assets,
net |
|
|
15,969 |
|
|
|
|
|
16,672 |
|
|
Other assets |
|
|
2,552 |
|
|
|
|
|
2,470 |
|
|
Total assets |
$ |
|
97,435 |
|
|
|
$ |
|
122,510 |
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
Current
Liabilities: |
|
|
|
|
|
|
|
Accounts
payable |
$ |
|
7,808 |
|
|
|
$ |
|
4,824 |
|
|
Accrued
expenses |
|
|
7,860 |
|
|
|
|
|
3,141 |
|
|
Deferred
revenue |
|
|
2,558 |
|
|
|
|
|
- |
|
|
Current
portion of long-term debt |
|
|
3,188 |
|
|
|
|
|
7,973 |
|
|
Total current liabilities |
|
|
21,414 |
|
|
|
|
|
15,938 |
|
|
Long-Term
Liabilities: |
|
|
|
|
|
|
|
Long-term
debt, net of current portion |
|
|
58,524 |
|
|
|
|
|
26,271 |
|
|
Earnout
liability |
|
|
355 |
|
|
|
|
|
214 |
|
|
Deferred
gain on leaseback |
|
|
60 |
|
|
|
|
|
547 |
|
|
Deferred
rent |
|
|
1,184 |
|
|
|
|
|
1,166 |
|
|
Total long-term liabilities |
|
|
60,123 |
|
|
|
|
|
28,198 |
|
|
Stockholders'
Equity: |
|
|
|
|
|
|
|
Preferred
stock, $0.001 par value, 5,000,000 shares authorized,
no shares issued or outstanding at September 30, 2016
and December 31, 2015 |
|
|
- |
|
|
|
|
|
- |
|
|
Common
stock, $0.001 par value, 100,000,000 authorized at
September 30, 2016 and December 31, 2015;
16,079,902 and 16,070,705 issued and outstanding at
September 30, 2016 respectively; 16,025,155 and
16,015,958 issued and outstanding at December 31,
2015, respectively |
|
|
16 |
|
|
|
|
|
16 |
|
|
Treasury
stock, at cost, 9,197 shares at September 30,
2016 and December 31, 2015 |
|
|
(171 |
) |
|
|
|
|
(171 |
) |
|
Additional paid-in capital |
|
|
197,789 |
|
|
|
|
|
195,314 |
|
|
Accumulated deficit |
|
|
(181,745 |
) |
|
|
|
|
(116,785 |
) |
|
Accumulated other comprehensive income |
|
|
9 |
|
|
|
|
|
- |
|
|
Total stockholders' equity |
|
|
15,898 |
|
|
|
|
|
78,374 |
|
|
Total liabilities and stockholders’ equity |
$ |
|
97,435 |
|
|
|
$ |
|
122,510 |
|
|
Neos Therapeutics, Inc. and
Subsidiaries CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (UNAUDITED) |
|
|
|
|
|
For the Three Months Ended September
30, |
|
|
Nine Months Ended
September 30, |
|
In
thousands, except share and per share amounts |
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
product sales |
|
$ |
|
1583 |
|
|
|
$ |
|
221 |
|
|
|
$ |
|
5,651 |
|
|
|
$ |
|
2,133 |
|
|
Cost of goods sold |
|
|
|
2,289 |
|
|
|
|
|
1,172 |
|
|
|
|
|
7,301 |
|
|
|
|
|
4,070 |
|
|
Gross loss |
|
|
|
(706 |
) |
|
|
|
|
(951 |
) |
|
|
|
|
(1,650 |
) |
|
|
|
|
(1,937 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
|
2,910 |
|
|
|
|
|
2,658 |
|
|
|
|
|
8,722 |
|
|
|
|
|
8,965 |
|
|
Selling and marketing expenses |
|
|
|
16,977 |
|
|
|
|
|
1,399 |
|
|
|
|
|
39,630 |
|
|
|
|
|
2,370 |
|
|
General and administrative expenses |
|
|
|
3,140 |
|
|
|
|
|
1,967 |
|
|
|
|
|
9,600 |
|
|
|
|
|
4,891 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
|
(23,733 |
) |
|
|
|
|
(6,975 |
) |
|
|
|
|
(59,602 |
) |
|
|
|
|
(18,163 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
|
(2,130 |
) |
|
|
|
|
(1,044 |
) |
|
|
|
|
(4,746 |
) |
|
|
|
|
(2,685 |
) |
|
Loss on debt extinguishment |
|
|
|
- |
|
|
|
|
|
- |
|
|
|
|
|
(1,187 |
) |
|
|
|
|
- |
|
|
Other income, net |
|
|
|
155 |
|
|
|
|
|
518 |
|
|
|
|
|
716 |
|
|
|
|
|
623 |
|
|
Change in fair value of
earnout and warrant liabilities |
|
|
|
(98 |
) |
|
|
|
|
(1,867 |
) |
|
|
|
|
(141 |
) |
|
|
|
|
(1,452 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
|
(25,806 |
) |
|
|
$ |
|
(9,368 |
) |
|
|
$ |
|
(64,960 |
) |
|
|
$ |
|
(21,677 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock
accretion to redemption value |
|
|
|
- |
|
|
|
|
|
(99 |
) |
|
|
|
|
- |
|
|
|
|
|
(1,169 |
) |
|
Preferred Stock
Dividends |
|
|
|
- |
|
|
|
|
|
(138 |
) |
|
|
|
|
- |
|
|
|
|
|
(1,221 |
) |
|
Net loss attributable to common stock |
|
$ |
|
(25,806 |
) |
|
|
$ |
|
(9,605 |
) |
|
|
$ |
|
(64,960 |
) |
|
|
$ |
|
(24,067 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding used to compute net loss per share, basic and
diluted |
|
|
|
16,070,705 |
|
|
|
|
|
12,403,182 |
|
|
|
|
|
16,048,801 |
|
|
|
|
|
4,767,479 |
|
|
Net loss per share of common stock, basic
and diluted |
|
$ |
|
(1.61 |
) |
|
|
$ |
|
(0.77 |
) |
|
|
$ |
|
(4.05 |
) |
|
|
$ |
|
(5.05 |
) |
|
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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