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“We’ve launched three ADHD products in the last two years and are very pleased with our product portfolio, which we believe reflects both the strength of our unique technology platform as well as our ability to develop, manufacture and commercialize products,” said
Neos’ three commercial products are Adzenys XR-ODT®, Cotempla XR-ODT™ and Adzenys ER™ which launched in
Commercial Product Highlights as Reported by
|Cumulative total EUTRx* (4Q17)||Cumulative total EUTRx (4Q16)||Year-over-year increase||Cumulative total EUTRx since launch
(as of 3.2.18)
|Patients switching from another medication
(as of 2.23.18)
*EUTRx = Equivalent Unit TRx
Additional Commercial Product Highlights as Reported by
- Continued Strong Growth in Adzenys XR-ODT and Cotempla XR-ODT Prescription Trends: The cumulative total number of EUTRx for Adzenys XR-ODT were 62,737 for the three months ended
December 31, 2017, an increase of 23.7% over the 50,697 for the three months ended September 30, 2017. For Cotempla XR-ODT, the cumulative total number of EUTRx for the three months ended December 31, 2017were 12,073, compared to 648 EUTRx for the three months ended September 30, 2017.
- Market Share of Neos’ XR-ODT Products is Increasing: The combined total weekly prescriptions for Adzenys XR-ODT and Cotempla XR-ODT continued to grow and had increased to 9,031 weekly EUTRx for the week ended
March 2, 2018. This represents an aggregate market share of 0.54% of the entire ADHD market.
- The Number of Prescribers of Adzenys XR-ODT and Cotempla XR-ODT Continues to Grow: As of
December 31, 2017, 10,870 health care providers had written prescriptions for Adzenys XR-ODT since its launch, and 1,949 health care providers had written prescriptions for Cotempla XR-ODT since its launch. As of the week ended February 16, 2018, those numbers had increased to 11,619 and 3,480, respectively.
- Patient Switching from Another ADHD Medication Continues to be an Important Driver of Product Uptake: Doctors are switching patients over from other ADHD medications to both Adzenys XR-ODT (71% switching) and Cotempla XR-ODT (79% switching).
January 2018, the Company announced that study findings for two of its ADHD medications, Cotempla XR-ODT and Adzenys ER, were presented in three posters at the 2018 Annual Meeting of the American Professional Society of ADHD and Related Disorders. The results showed efficacy, safety and tolerability of Cotempla XR-ODT in children 6-12 years of age in a laboratory classroom study, and demonstrated bioequivalence of Adzenys ER with Adderall XR.
February 26, 2018, the Company announced the U.S. commercial launch of Adzenys ER (amphetamine) Extended-Release Oral Suspension, its third ADHD product. This product received approval from the U.S. Food and Drug Administration( FDA) on September 15, 2017for the treatment of ADHD in patients six years and older. This extended-release liquid medication does not require refrigeration or reconstitution at the pharmacy level. Adzenys ER oral suspension utilizes the same proprietary modified-release drug delivery technology as Adzenys XR-ODT.
Select Financial Results for the Fourth Quarter and Fiscal Year Ended
- Total product revenues were
$7.8 millionfor the three months ended December 31, 2017, compared to $3.5 millionfor the same period in 2016, and for the fiscal year ended December 31, 2017, total product revenues were $25.0 million, compared with $9.2 millionfor the same period in 2016. For the three months ended December 31, 2017, total product revenues associated with dispensed patient prescriptions for the Company’s ADHD products were $7.2 million.
|Net product sales (in $millions)|
|Q4 2017||Q4 2016||Change %||FY 2017||FY 2016||Change %|
- The Company reported a gross profit of
$5.0 millionfor the three months ended December 31, 2017, compared to a gross loss of $0.5 million for the same period in 2016, and for the fiscal year ended December 31, 2017, gross profit was $12.6 millionas compared to a gross loss of $2.3 millionfor the same period of 2016.
- Research and development expenses for the three months ended
December 31, 2017, were $1.8 million, compared to $3.6 millionfor the same period in 2016, and for the fiscal year ended December 31, 2017, research and development expenses were $9.0 millioncompared to $12.2 millionfor the same period of 2016. The decrease in the fourth quarter was primarily due to a decline in testing, materials and supply expenses due to the approval of the Company’s ADHD product candidates in 2017 coupled with a non-recurring FDAfee associated with the filing of the New Drug Application for Adzenys ER in 2016.
- Selling and marketing expenses were
$11.9 million for the three months ended December 31, 2017, compared to $9.7 million for the same period in 2016, and for the fiscal year ended December 31, 2017, selling and marketing expenses were $46.9 millioncompared to $49.3 millionfor the same period in 2016. The fourth quarter increase was principally due to higher medical marketing costs as well as increased transaction fees associated with the higher level of prescriptions processed for the Company’s products.
- General and administrative expenses for the three months ended
December 31, 2017, were $3.0 million compared to $3.0 millionfor the same period in 2016, and for the fiscal year ended December 31, 2017, general and administrative expenses were $13.8 millioncompared to $12.6 millionfor the same period in 2016.
- The Company reported a net loss of
$14.2 million, or $0.49per share, for the three months ended December 31, 2017, compared to a net loss of $18.4 million, or $1.14per share, for the same period in 2016. For the fiscal year ended December 31, 2017, the Company reported a net loss of $66.2 million, or $2.68per share, compared to a net loss of $83.3 million, or $5.19per share for the fiscal year ended December 31, 2016.
December 31, 2017, the Company held $50.4 millionin cash and cash equivalents and short-term investments.
Conference Call Details
1Tussionex® is a registered trademark of the UCB Group of Companies.
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-ODT, Cotempla XR-ODT™ and Adzenys ER, our marketing plans, and the therapeutic potential of our 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 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 Subsidiaries|
|CONSOLIDATED BALANCE SHEETS|
|(In thousands, except share and per share data)|
|Cash and cash equivalents||$||31,969||$||24,352|
|Accounts receivable, net of allowances for chargebacks and cash discounts of $1,154
and $950, respectively
|Deferred contract sales organization fees||—||720|
|Other current assets||5,093||2,865|
|Total current assets||82,640||55,269|
|Property and equipment, net||8,203||7,076|
|Intangible assets, net||16,348||17,647|
|LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)|
|Current portion of long‑term debt||896||4,921|
|Total current liabilities||37,602||21,645|
|Long‑term debt, net of current portion||58,938||58,599|
|Other long-term liabilities||180||272|
|Total long‑term liabilities||61,861||60,045|
|Stockholders’ Equity (Deficit):|
|Preferred stock, $0.001 par value, 5,000,000 shares authorized, no shares issued or outstanding at
December 31, 2017 and December 31, 2016
|Common stock, $0.001 par value, 100,000,000 authorized at December 31, 2017 and December 31, 2016;
29,030,757 and 28,996,956 issued and outstanding, respectively, at December 31, 2017; 16,079,902 and
16,060,996 issued and outstanding, respectively, at December 31, 2016
|Treasury stock, at cost, 33,801 shares at December 31, 2017 and 18,906 shares at December 31, 2016||(352||)||(232||)|
|Additional paid‑in capital||274,584||198,787|
|Accumulated other comprehensive loss||(6||)||(1||)|
|Total stockholders’ equity (deficit)||7,890||(1,548||)|
|Total liabilities and stockholders’ equity (deficit)||$||107,353||$||80,142|
|Neos Therapeutics, Inc. and Subsidiaries|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except share and per share data)|
|Three Months Ended
|Net product sales||$||7,787||$||3,503||$||25,018||$||9,154|
|Cost of goods sold||2,778||4,020||12,391||11,437|
|Gross profit (loss)||5,009||(517||)||12,627||(2,283||)|
|Research and development expenses||1,784||3,602||8,957||12,207|
|Selling and marketing expenses||11,851||9,661||46,881||49,291|
|General and administrative expenses||3,039||3,025||13,805||12,625|
|Loss from operations||(11,665||)||(16,805||)||(57,016||)||(76,406||)|
|Loss on debt extinguishment||—||—||—||(1,187||)|
|Other income, net||276||622||854||1,197|
|Weighted average common shares outstanding used to compute net loss per share,
basic and diluted
|Net loss per share of common stock, basic and diluted||$||(0.49||)||$||(1.14||)||$||(2.68||)||$||(5.19||)|
Chief Financial Officer
Stern Investor Relations, Inc.