DALLAS and FORT WORTH, Texas, Aug. 08, 2018 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (Nasdaq: NEOS), a fully integrated pharmaceutical company focused on developing, manufacturing and commercializing innovative extended-release (XR) products using its proprietary modified-release drug delivery technologies, today reported financial results for the second quarter ended June 30, 2018 and provided a business update.
“Second quarter revenues for our ADHD products were $10.8 million which represents a 22.5% growth over first quarter revenues. With over 7,500 prescribers of Adzenys XR-ODT and over 4,700 prescribers of Cotempla XR-ODT in the second quarter alone, we believe we are in a strong position to drive prescription growth as many school-aged ADHD patients visit their health care provider for back to school physicals,” said Jerry McLaughlin, Chief Executive Officer of Neos Therapeutics. “Our ADHD products provide a solid and growing base of business and our primary goals are to continue to increase market share for these products, achieve profitability and strategically expand our pipeline and commercial product portfolio. With continued careful management of our cash flow, we are happy to report a cash position of approximately $29.1 million at the end of July versus a cash position of $28.0 million at the end of June.”
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 upcoming back to school season.
| Cumulative TRx (2Q18) | Cumulative TRx (2Q17) | Year-over-year increase | Patients switching from another medication (as of 7/13/18) | ||
| Adzenys XR-ODT® | 59,891 | 39,968 | 50% | 69% | |
| Cotempla XR-ODT® | 35,910 | N/A | N/A | 76% | |
* As reported by IQVIA
Additional Commercial Product Highlights
- Rapid Growth Continues During First Year of Launch for Cotempla XR-ODT: Monthly prescriptions for Cotempla XR-ODT, as reported by IQVIA, have grown 40% per month since its launch in September 2017.
- The Number of Prescribers of Neos ADHD Products Continues to Grow: As of June 30, 2018, as reported by IQVIA, 13,615 health care providers had written prescriptions for Adzenys XR-ODT since its launch, and 6,102 health care providers had written prescriptions for Cotempla XR-ODT since its launch.
Select Financial Results for the Second Quarter Ended June 30, 2018
- Total product revenues were $11.4 million for the three months ended June 30, 2018, compared to $5.2 million for the same period in 2017. For the three months ended June 30, 2018, total product revenues were $10.8 million for the Company’s ADHD products and $0.6 million for generic Tussionex.
| Q2 2018 | Q2 2017 | % Change | |
| Adzenys XR-ODT | $6.5MM | $4.4MM | 47.7% |
| Cotempla XR-ODT | $4.3MM | N/A | N/A |
| Generic Tussionex | $0.6MM | $0.8MM | (25.0)% |
| Total | $11.4MM | $5.2MM | 119.2% |
| Adzenys ER revenue was negligible in Q2 2018 | |||
- The Company reported a gross profit of $4.4 million for the three months ended June 30, 2018, compared to a gross profit of $2.4 million for the same period in 2017.
- Research and development expenses for the three months ended June 30, 2018, were $2.4 million compared to $3.7 million for the same period in 2017.
- Selling and marketing expenses were $11.6 million for the three months ended June 30, 2018, compared to $11.7 million for the same period in 2017.
- General and administrative expenses for the three months ended June 30, 2018, were $3.7 million compared to $3.3 million for the same period in 2017.
- The Company reported a net loss of $15.2 million, or $0.52 per share, for the three months ended June 30, 2018, compared to a net loss of $18.6 million, or $0.82 per share, for the same period in 2017.
- At June 30, 2018, the Company held $28.0 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 5853008. 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. (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 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-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 and the research and development plan for our potential product candidates. 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 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)
| June 30, | December 31, | |||||||
| 2018 | 2017 | |||||||
| (as adjusted) | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 18,318 | $ | 31,969 | ||||
| Short-term investments | 9,722 | 18,448 | ||||||
| Accounts receivable, net of allowances for chargebacks and cash discounts of $788 and $1,154, respectively | 17,977 | 13,671 | ||||||
| Inventories | 12,713 | 11,732 | ||||||
| Other current assets | 1,336 | 3,575 | ||||||
| Total current assets | 60,066 | 79,395 | ||||||
| Property and equipment, net | 8,269 | 8,203 | ||||||
| Intangible assets, net | 15,507 | 16,348 | ||||||
| Other assets | 150 | 162 | ||||||
| Total assets | $ | 83,992 | $ | 104,108 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 6,060 | $ | 11,460 | ||||
| Accrued expenses | 34,128 | 20,944 | ||||||
| Current portion of long-term debt | 15,983 | 896 | ||||||
| Total current liabilities | 56,171 | 33,300 | ||||||
| Long-Term Liabilities: | ||||||||
| Long-term debt, net of current portion | 43,932 | 58,938 | ||||||
| Derivative liability | 1,311 | 1,660 | ||||||
| Deferred rent | 1,036 | 1,083 | ||||||
| Other long-term liabilities | 178 | 180 | ||||||
| Total long-term liabilities | 46,457 | 61,861 | ||||||
| Stockholders’ Equity (Deficit): | ||||||||
| Preferred stock, $0.001 par value, 5,000,000 shares authorized, no shares issued or outstanding at June 30, 2018 and December 31, 2017 | — | — | ||||||
| Common stock, $0.001 par value, 100,000,000 authorized at June 30, 2018 and December 31, 2017; 29,048,589 and 29,014,788 issued and outstanding at June 30, 2018, respectively; 29,030,757 and 28,996,956 issued and outstanding at December 31, 2017, respectively | 29 | 29 | ||||||
| Treasury stock, at cost, 33,801 shares at June 30, 2018 and December 31, 2017 | (352 | ) | (352 | ) | ||||
| Additional paid-in capital | 276,637 | 274,584 | ||||||
| Accumulated deficit | (294,951 | ) | (265,308 | ) | ||||
| Accumulated other comprehensive loss | 1 | (6 | ) | |||||
| Total stockholders’ equity (deficit) | (18,636 | ) | 8,947 | |||||
| Total liabilities and stockholders’ equity | $ | 83,992 | $ | 104,108 | ||||
Neos Therapeutics, Inc. and Subsidiaries
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
(unaudited)
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||
| 2018 | 2017 (as adjusted) | 2018 | 2017 (as adjusted) | ||||||||||
| Revenues: | |||||||||||||
| Net product sales | $ | 11,363 | $ | 5,179 | $ | 22,092 | $ | 10,810 | |||||
| Cost of goods sold | 6,987 | 2,817 | 12,208 | 7,567 | |||||||||
| Gross profit | 4,376 | 2,362 | 9,884 | 3,243 | |||||||||
| Research and development | 2,381 | 3,692 | 4,072 | 5,416 | |||||||||
| Selling and marketing expenses | 11,557 | 11,706 | 24,547 | 22,412 | |||||||||
| General and administrative expenses | 3,705 | 3,316 | 7,051 | 6,854 | |||||||||
| Loss from operations | (13,267 | ) | (16,352 | ) | (25,786 | ) | (31,439 | ) | |||||
| Interest expense | (2,232 | ) | (2,390 | ) | (4,452 | ) | (4,602 | ) | |||||
| Other income, net | 292 | 97 | 595 | 175 | |||||||||
| Net loss | $ | (15,207 | ) | $ | (18,645 | ) | $ | (29,643 | ) | $ | (35,866 | ) | |
| Weighted average common shares outstanding used to compute net loss per share, basic and diluted | 29,008,909 | 22,613,382 | 29,002,966 | 21,127,303 | |||||||||
| Net loss per share of common stock, basic and diluted | $ | (0.52 | ) | $ | (0.82 | ) | $ | (1.02 | ) | $ | (1.70 | ) | |
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