Company to host conference call today at 8:30am
ET
Neos Therapeutics, Inc. (Nasdaq: NEOS), a fully-integrated
pharmaceutical company focused on developing, manufacturing, and
commercializing innovative modified-release products using its
proprietary microparticle, drug delivery technology, today reported
financial results for the third quarter ended September 30, 2018
and provided a business update.
“Our ADHD business grew 9% in prescription
volume in the third quarter compared to the previous quarter of
2018 and we reported that the net revenue per pack for both Adzenys
XR-ODT and Cotempla XR-ODT was $108. This compares to $95 and $89
respectively for the prior quarter. This improvement in net revenue
per pack resulted in part from the programs that we are just
beginning to implement to accelerate our path to profitability,”
said Jerry McLaughlin, Chief Executive Officer of Neos
Therapeutics. “With our ADHD products providing a solid and growing
base of business, and the additional financial flexibility from our
recently completed financing and debt restructuring, we look
forward to advancing our whole business and expanding our
development pipeline and commercial portfolio. We were pleased to
have recently announced the licensing of a pipeline candidate for
the treatment of sialorrhea and plan to continue this momentum into
2019.”
Commercial Product
Highlights
Neos’ three commercial attention deficit
hyperactivity disorder (ADHD) products are Adzenys
XR-ODT®, Cotempla XR-ODT® and Adzenys
ER™ which launched in May 2016, September 2017 and
February 2018, respectively. Continued growth in
prescription trends for Adzenys XR-ODT and Cotempla XR-ODT builds
momentum for the Neos ADHD franchise.
|
Cumulative TRx (3Q18) |
Cumulative TRx (3Q17) |
Year-over-year
increase |
Patients switching from
another medication (3Q18) |
Adzenys XR-ODT® |
64,397 |
48,418 |
33 |
% |
70 |
% |
Cotempla
XR-ODT® |
39,695 |
N/A |
N/A |
72 |
% |
* As reported by IQVIA
Additional Commercial Product
Highlights
- Strong Growth Continues Into Second Year of Launch for
Cotempla XR-ODT: Monthly prescriptions for Cotempla
XR-ODT, as reported by IQVIA, have grown 29.6% per month since its
launch in September 2017.
- Substantial Increase in Net Revenue Per Pack from Prior
Quarter: As of September 30, 2018, the company’s net
revenue per pack for Adzenys XR-ODT and Cotempla XR-ODT was $108
compared to $95 and $89, respectively for the quarter ended June
30, 2018. Because of seasonality due to high deductible plans, as
an additional comparison, the company’s net revenue per pack for
Adzenys XR-ODT in the third quarter of 2017 was $96.
- The Number of Prescribers of Neos ADHD Products
Continues to Grow: As of September 30, 2018, as reported
by IQVIA, 15,036 health care providers had written prescriptions
for Adzenys XR-ODT since its launch, and 7,485 health care
providers had written prescriptions for Cotempla
XR-ODT since its launch.
Corporate Updates
On November 8, 2018, the Company closed an
underwritten public offering of 19,999,999 shares of its common
stock at a public offering price of $2.30 per share, which includes
the exercise in full by the underwriters of their option to
purchase up to an additional 2,608,695 shares of common stock. The
net proceeds to the company from this offering, after deducting
underwriting discounts and commissions and offering expenses
payable by the company and taking into account of certain
reimbursement by the underwriters, were approximately $43.4
million.
Simultaneous with this financing, the company
amended its $60.0 million term loan from Deerfield Management. The
company agreed to pay $7.5 million of principal under the Facility
otherwise due in May 2019 upon completion of the financing. The
Second Amendment provides an option for the $15.0 million principal
on the Facility due in May 2020 to be paid in either May 2021 or
May 2022 upon the achievement of certain revenue milestones as
described in the Second Amendment. Also, pursuant to the Second
Amendment, the Company amended and restated its outstanding notes
under the Facility in the form of senior secured convertible notes.
The Company has the right to pay principal and future interest in
shares of Common Stock not to exceed 2,135,625 shares in the
aggregate. Additionally, Deerfield has the right to convert the
remaining principal under the Facility into shares of Common Stock
not to exceed 3,796,668 shares in the aggregate at a conversion
price of 95% of the greater of (A) the average of the volume
weighted average price per share of the Common Stock for the three
trading day period immediately preceding such conversion and (B)
$10.00.
Select Financial Results for the Third
Quarter Ended September 30, 2018
- Total product revenues were $12.5 million for the three months
ended September 30, 2018, compared to $7.1 million for the same
period in 2017. For the three months ended September 30, 2018,
total product revenues were $11.9 million for the Company’s ADHD
products and $0.6 million for generic Tussionex.
|
Q3 2018 |
Q3 2017 |
% Change |
Adzenys XR-ODT |
$7.0MM |
$5.3MM |
32.1 |
% |
Cotempla XR-ODT |
$4.9MM |
$0.4MM |
1,125.0 |
% |
Generic Tussionex |
$0.6MM |
$1.4MM |
(57.1 |
)% |
Total |
$12.5MM |
$7.1MM |
76.1 |
% |
Adzenys ER revenue was
negligible in Q3 2018 |
- The Company reported a gross profit of $5.5 million for the
three months ended September 30, 2018, compared to a gross profit
of $4.3 million for the same period in 2017.
- Research and development expenses for the three months ended
September 30, 2018, were $2.0 million compared to $1.8 million for
the same period in 2017.
- Selling and marketing expenses were $10.4 million for the
three months ended September 30, 2018, compared to
$12.6 million for the same period in 2017.
- General and administrative expenses for the three months ended
September 30, 2018, were $3.5 million compared to $3.9 million for
the same period in 2017.
- The Company reported a net loss of $12.7 million, or $0.43 per
share, for the three months ended September 30, 2018, compared to a
net loss of $16.3 million, or $0.58 per share, for the same
period in 2017.
- At September 30, 2018, the Company held $16.6 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 6737227. 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 three
approved products using the Company’s extended-release technology
platform. Additional information about Neos is available at
www.neostx.com.
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 prescription growth
for our products, our marketing plans, the therapeutic potential of
our products, the strategic expansion of our product pipeline and
commercial product portfolio, the research and development plan for
our potential product candidates, including licensed product
candidates, the terms of our amended senior debt facility, our
financial position and cash runway, and the growth and
profitability of our business. 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, the inherent uncertainty of drug
research and development and commercialization, that we may use our
cash resources more quickly than anticipated, 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 |
|
(In thousands, except share and
per share data) |
|
(unaudited) |
|
|
|
|
|
September
30, |
|
December 31, |
|
|
|
2018 |
|
|
2017(as
adjusted) |
|
ASSETS |
|
|
|
|
|
Current Assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
16,555 |
|
|
$ |
31,969 |
|
Short-term investments |
|
— |
|
|
18,448 |
|
Accounts receivable, net of allowances for
chargebacks and cash discounts of $1,114 and $1,154,
respectively |
|
20,338 |
|
|
13,671 |
|
Inventories |
|
11,974 |
|
|
11,732 |
|
Other current assets |
|
1,175 |
|
|
3,575 |
|
Total current assets |
|
50,042 |
|
|
79,395 |
|
|
|
|
|
|
|
Property and equipment, net |
|
8,047 |
|
|
8,203 |
|
Intangible assets, net |
|
15,042 |
|
|
16,348 |
|
Other assets |
|
149 |
|
|
162 |
|
|
|
|
|
|
|
Total assets |
|
$ |
73,280 |
|
|
$ |
104,108 |
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
(DEFICIT) |
|
|
|
|
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
Accounts payable |
|
$ |
7,503 |
|
|
$ |
11,460 |
|
Accrued expenses |
|
29,947 |
|
|
20,944 |
|
Current portion of long-term debt |
|
16,019 |
|
|
896 |
|
|
|
|
|
|
|
Total current liabilities |
|
53,469 |
|
|
33,300 |
|
|
|
|
|
|
|
Long-Term Liabilities: |
|
|
|
|
|
Long-term debt, net of current portion |
|
43,892 |
|
|
58,938 |
|
Derivative liability |
|
1,367 |
|
|
1,660 |
|
Deferred rent |
|
1,012 |
|
|
1,083 |
|
Other long-term liabilities |
|
177 |
|
|
180 |
|
|
|
|
|
|
|
Total long-term liabilities |
|
46,448 |
|
|
61,861 |
|
|
|
|
|
|
|
Stockholders’ Equity (Deficit): |
|
|
|
|
|
Preferred stock, $0.001 par value, 5,000,000 shares
authorized, no shares issued or outstanding at September 30, 2018
and December 31, 2017 |
|
— |
|
|
— |
|
Common stock, $0.001 par value, 100,000,000
authorized at September 30, 2018 and December 31, 2017; 29,707,711
and 29,673,910 issued and outstanding at September 30, 2018,
respectively; 29,030,757 and 28,996,956 issued and outstanding at
December 31, 2017, respectively |
|
30 |
|
|
29 |
|
Treasury stock, at cost, 33,801 shares at September
30, 2018 and December 31, 2017 |
|
(352 |
) |
|
(352 |
) |
Additional paid-in capital |
|
281,331 |
|
|
274,584 |
|
Accumulated deficit |
|
(307,646 |
) |
|
(265,308 |
) |
Accumulated other comprehensive income (loss) |
|
— |
|
|
(6 |
) |
|
|
|
|
|
|
Total stockholders’ (deficit)
equity |
|
(26,637 |
) |
|
8,947 |
|
|
|
|
|
|
|
Total liabilities and stockholders’
(deficit) equity |
|
$ |
73,280 |
|
|
$ |
104,108 |
|
Neos
Therapeutics, Inc. and Subsidiaries |
|
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS |
|
(In thousands, except share and
per share data) |
|
(unaudited) |
|
|
|
|
|
Three Months EndedSeptember
30, |
|
Nine
months Ended September 30, |
|
|
|
2018 |
|
2017(as
adjusted) |
|
2018 |
|
2017(as
adjusted) |
|
Revenues: |
|
|
|
|
|
|
|
|
|
Net product sales |
|
$ |
12,503 |
|
$ |
7,100 |
|
$ |
34,595 |
|
$ |
17,910 |
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
6,957 |
|
2,823 |
|
19,165 |
|
10,390 |
|
Gross profit |
|
5,546 |
|
4,277 |
|
15,430 |
|
7,520 |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
2,037 |
|
1,757 |
|
6,109 |
|
7,173 |
|
Selling and marketing expenses |
|
10,446 |
|
12,618 |
|
34,993 |
|
35,030 |
|
General and administrative expenses |
|
3,537 |
|
3,911 |
|
10,588 |
|
10,766 |
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(10,474 |
) |
(14,009 |
) |
(36,260 |
) |
(45,449 |
) |
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
(2,260 |
) |
(2,648 |
) |
(6,712 |
) |
(7,250 |
) |
Other income, net |
|
39 |
|
403 |
|
634 |
|
578 |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(12,695 |
) |
$ |
(16,254 |
) |
$ |
(42,338 |
) |
$ |
(52,121 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding used to compute net loss
per share, basic and diluted |
|
29,625,792 |
|
27,884,983 |
|
29,212,856 |
|
23,404,617 |
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of common stock, basic and
diluted |
|
$ |
(0.43 |
) |
$ |
(0.58 |
) |
$ |
(1.45 |
) |
$ |
(2.23 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contacts:
Richard EisenstadtChief Financial OfficerNeos
Therapeutics(972) 408-1389reisenstadt@neostx.com
Sarah McCabeStern Investor Relations, Inc.(212)
362-1200sarah@sternir.com
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