Neos Therapeutics Reports Third Quarter 2017 Financial Results
08 November 2017 - 11:00PM
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) technologies, today reported financial
results for the third quarter ended September 30, 2017, and
provided a business update.
“We recently launched our second ADHD product,
Cotempla XR-ODT™, and we are very pleased to report that the
prescription trends so far are very encouraging. We believe this
is, in part, the result of our established relationships with
nearly 10,000 healthcare professionals, their awareness of our
XR-ODT technology and their interest in using our innovative
products,” said Vipin K. Garg, Ph.D., President and CEO of Neos
Therapeutics. “Along with our first product, Adzenys XR-ODT®, we
expect to see continued commercial growth, and believe that Neos
stands out as the only company to have both a branded
methylphenidate and a branded amphetamine product available in an
extended-release orally disintegrating tablet dosage form. We are
also looking forward to the launch of our amphetamine oral
suspension product, Adzenys ER™, expected in early 2018.”
Third Quarter and Recent
Announcements
- On September 5, 2017, Neos announced a limited-availability
early experience program for Cotempla XR-ODT, the first and only
methylphenidate extended-release orally disintegrating tablet for
the treatment of attention deficit/hyperactivity disorder (ADHD) in
patients 6 to 17 years old. The full US commercial launch occurred
on October 2, 2017.
- On September 15, 2017, Adzenys ER (amphetamine)
Extended-Release Oral Suspension, a once-daily, extended-release
liquid medication that does not require refrigeration or
reconstitution at the pharmacy level, received approval from the
U.S. Food and Drug Administration (FDA). The Company expects
Adzenys ER will be commercially available in early 2018.
- On October 17, 2017, the Company entered into a confidential
settlement and licensing agreement with Actavis Laboratories FL,
Inc. (Actavis) to resolve all ongoing litigation involving Neos'
patents protecting its Adzenys XR-ODT product. Under the settlement
and license agreement, Neos has granted Actavis the right to
manufacture and market its generic version of Adzenys XR-ODT under
the Actavis Abbreviated New Drug Application beginning on September
1, 2025, or earlier under certain circumstances.
- In October, the Company presented two posters at the 64th
Annual Meeting of the American Academy of Child & Adolescent
Psychiatry (AACAP) in Washington, D.C. One showed a lack of food
effect, a key favorable attribute of Adzenys ER, and the other
presented a PK/PD model for dose optimization of Cotempla XR-ODT
tablets in patients with ADHD.
Commercial Product
Highlights
- Adzenys XR-ODT®
- Prescription Trends Continue to Show Strong Growth
Momentum: Adzenys XR-ODT continued to perform well, and
the cumulative total number of prescriptions filled for Adzenys
XR-ODT, as reported by QuintilesIMS, were 50,697 for the three
months ended September 30, 2017, an increase of 20.8% over the
41,954 for the three months ended June 30, 2017. Monthly
prescriptions through October 27, 2017, for Adzenys XR-ODT, as
reported by QuintilesIMS, were 19,036. As of October 27, 2017, the
cumulative total number of prescriptions filled for Adzenys XR-ODT
since its launch in May 2016, as reported by QuintilesIMS, were
174,323.
- Number of Prescribers Continues to Increase
Nationally: The number of prescribers of Adzenys XR-ODT
continued to grow, and as of September 29, 2017, 9,086 health care
providers had written prescriptions for the product since its
launch. As of the week ended October 13, 2017, that number had
increased to 9,542.
- Doctors are Switching Patients Over to Adzenys
XR-ODT: Patients switching from another ADHD medication
accounted for approximately 73% of all new Adzenys XR-ODT
prescriptions, as reported by QuintilesIMS, as of the week ended
October 20, 2017.
- Product Appeal for All Patient Types: As of
the week ended October 20, 2017, as reported by QuintilesIMS, 60%
of all new Adzenys XR-ODT prescriptions were for pediatric patients
and 40% were for adult patients, indicating a broad appeal of
Adzenys XR-ODT in all patient types.
- Cotempla XR-ODT™
- Launch Off to Solid Start: The number of
equivalent unit prescriptions filled for Cotempla XR-ODT through
September 30, 2017, as reported by QuintilesIMS, during the
limited-availability early experience program was 648. Monthly
equivalent unit prescriptions through October 27, 2017, for
Cotempla XR-ODT, as reported by QuintilesIMS, were 2,100. As of
October 27, 2017, the cumulative total number of equivalent unit
prescriptions filled for Cotempla XR-ODT since its launch, as
reported by QuintilesIMS, were 2,748.
- Doctors are Switching Patients Over to Cotempla
XR-ODT: Patients switching from another ADHD medication
accounted for approximately 76% of all new Cotempla XR-ODT
prescriptions, as reported by QuintilesIMS, as of the week ended
October 20, 2017.
Select Financial Results for the Third
Quarter Ended September 30, 2017
- Total product revenues were $6.7 million for the three months
ended September 30, 2017, compared to $1.6 million for the same
period in 2016. This includes product revenue associated with
dispensed patient prescriptions of Adzenys XR-ODT of $5.3 million
and $1.4 million in net sales for generic Tussionex. Sales from the
early experience program for Cotempla XR-ODT, which commenced on
September 5, 2017, were negligible.
- The Company reported a gross profit of $4.3 million for the
three months ended September 30, 2017, compared to a gross loss of
$0.7 million for the same period in 2016.
- Research and development expenses for the three months ended
September 30, 2017, were $1.8 million, compared to $2.9 million for
the same period in 2016. The decrease was primarily due to a
decline in testing, materials and supply expenses for the Company’s
ADHD product candidates coupled with a reduction in clinical
expenses due to completion of studies for Cotempla XR-ODT and
Adzenys ER in 2016.
- Selling and marketing expenses were $12.6 million for the
three months ended September 30, 2017, compared to
$17.0 million for the same period in 2016. The decreased
expense was due to a decrease in advertising agency fees and other
costs expensed in 2016 for the Adzenys XR-ODT launch.
- General and administrative expenses for the three months ended
September 30, 2017, were $3.9 million, compared to $3.1
million for the same period in 2016.
- The Company reported a net loss of $16.3 million for the three
months ended September 30, 2017, compared to a net loss of
$25.8 million for the same period in 2016.
- The Company reported net loss per share of $0.58 for the three
months ended September 30, 2017, compared to a net loss per share
of $1.61 for the same period in 2016.
- At September 30, 2017, the Company held $66.5 million in cash
and cash equivalents and 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 97314658. 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. (NASDAQ:NEOS) is a pharmaceutical company
focused on developing, manufacturing and commercializing products
utilizing its proprietary modified-release drug delivery technology
platforms. Adzenys XR-ODT® (amphetamine) extended-release orally
disintegrating tablets (see Full Prescribing Information, including
Boxed WARNING), Cotempla XR-ODT™ (methylphenidate) extended-release
orally disintegrating tablets (see Full Prescribing Information,
including Boxed WARNING), and Adzenys-ER™ (amphetamine)
extended-release oral suspension (see Full Prescribing Information,
including Boxed WARNING), all for the treatment of ADHD, are the
first three approved products using the Company’s
extended-release technology platform. In addition, Neos
manufactures and markets its generic version of the branded product
Tussionex®1, an extended-release oral suspension of hydrocodone and
chlorpheniramine for the relief of cough and upper respiratory
symptoms of a cold (see Full Prescribing Information, including
Boxed WARNING). Additional information about Neos is available at
www.neostx.com.
1Tussionex® is a registered trademark of
the UCB Group of Companies.
Forward-Looking StatementsThis
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-ODT, Cotempla XR-ODT™ and Adzenys ER, the commercial
launch date for Adzenys ER, our marketing plans, the therapeutic
potential of our products, our settlement and licensing agreement
with Actavis and new product exclusivity for Cotempla XR-ODT.
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 market and sell our products 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
SubsidiariesCONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)(In thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
|
2017 |
|
2016 |
|
|
ASSETS |
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
43,398 |
|
$ |
24,352 |
|
|
Short-term investments |
|
23,089 |
|
15,430 |
|
|
Accounts
receivable, net of allowances for chargebacks and cash discounts of
$2,605 and $950, respectively |
|
8,619 |
|
6,135 |
|
|
Inventories |
|
9,992 |
|
5,767 |
|
|
Deferred
contract sales organization fees |
|
70 |
|
720 |
|
|
Other
current assets |
|
2,760 |
|
2,865 |
|
|
Total current assets |
|
87,928 |
|
55,269 |
|
|
|
|
|
|
|
|
|
Property and equipment,
net |
|
8,223 |
|
7,076 |
|
|
Intangible assets,
net |
|
16,739 |
|
17,647 |
|
|
Other assets |
|
192 |
|
150 |
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
113,182 |
|
$ |
80,142 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY (DEFICIT) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
Liabilities: |
|
|
|
|
|
|
Accounts
payable |
|
$ |
10,706 |
|
$ |
7,798 |
|
|
Accrued
expenses |
|
9,385 |
|
5,264 |
|
|
Deferred
revenue |
|
9,327 |
|
3,662 |
|
|
Current
portion of long-term debt |
|
6,949 |
|
4,921 |
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
36,367 |
|
21,645 |
|
|
|
|
|
|
|
|
|
Long-Term
Liabilities: |
|
|
|
|
|
|
Long-term
debt, net of current portion |
|
58,970 |
|
58,599 |
|
|
Derivative liability |
|
1,884 |
|
— |
|
|
Deferred
rent |
|
1,106 |
|
1,174 |
|
|
Other
long-term liabilities |
|
155 |
|
272 |
|
|
|
|
|
|
|
|
|
Total long-term liabilities |
|
62,115 |
|
60,045 |
|
|
|
|
|
|
|
|
|
Stockholders’ Equity
(Deficit): |
|
|
|
|
|
|
Preferred
stock, $0.001 par value, 5,000,000 shares authorized, no shares
issued or outstanding at September 30, 2017 and
December 31, 2016 |
|
— |
|
— |
|
|
Common
stock, $0.001 par value, 100,000,000 authorized at September 30,
2017 and December 31, 2016; 28,099,541 and 28,080,635 issued
and outstanding at September 30, 2017, respectively;
16,079,902 and 16,060,996 issued and outstanding at
December 31, 2016, respectively |
|
28 |
|
16 |
|
|
Treasury
stock, at cost, 18,906 shares at September 30, 2017 and
December 31, 2016 |
|
(232 |
) |
(232 |
) |
|
Additional paid-in capital |
|
267,046 |
|
198,787 |
|
|
Accumulated deficit |
|
(252,141 |
) |
(200,118 |
) |
|
Accumulated other comprehensive loss |
|
(1 |
) |
(1 |
) |
|
|
|
|
|
|
|
|
Total stockholders’ equity (deficit) |
|
14,700 |
|
(1,548 |
) |
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity |
|
$ |
113,182 |
|
$ |
80,142 |
|
|
|
|
|
|
|
|
Neos Therapeutics, Inc. and
SubsidiariesCONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (UNAUDITED)(In thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
2017 |
|
2016 |
|
2017 |
|
2016 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
Net
product sales |
|
$ |
6,695 |
|
$ |
1,583 |
|
$ |
17,231 |
|
$ |
5,651 |
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
2,422 |
|
2,318 |
|
9,613 |
|
7,418 |
|
Gross profit (loss) |
|
4,273 |
|
(735 |
) |
7,618 |
|
(1,767 |
) |
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
1,757 |
|
2,881 |
|
7,173 |
|
8,605 |
|
Selling and marketing
expenses |
|
12,618 |
|
16,977 |
|
35,030 |
|
39,630 |
|
General and
administrative expenses |
|
3,911 |
|
3,140 |
|
10,766 |
|
9,600 |
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(14,013 |
) |
(23,733 |
) |
(45,351 |
) |
(59,602 |
) |
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
(2,648 |
) |
(2,130 |
) |
(7,250 |
) |
(4,746 |
) |
Loss on debt
extinguishment |
|
— |
|
— |
|
— |
|
(1,187 |
) |
Other income, net |
|
403 |
|
57 |
|
578 |
|
575 |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(16,258 |
) |
$ |
(25,806 |
) |
$ |
(52,023 |
) |
$ |
(64,960 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding used to compute net loss per share, basic and
diluted |
|
27,884,983 |
|
16,070,705 |
|
23,404,617 |
|
16,048,801 |
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share of common stock, basic and diluted |
|
$ |
(0.58 |
) |
$ |
(1.61 |
) |
$ |
(2.22 |
) |
$ |
(4.05 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contacts:
Richard EisenstadtChief Financial OfficerNeos
Therapeutics(972) 408-1389reisenstadt@neostx.com
Sarah McCabeStern Investor Relations, Inc.(212)
362-1200sarah@sternir.com
Neos Therapeutics (NASDAQ:NEOS)
Historical Stock Chart
From Apr 2024 to May 2024
Neos Therapeutics (NASDAQ:NEOS)
Historical Stock Chart
From May 2023 to May 2024