Neos Therapeutics Reports Fourth Quarter and Year-End 2019 Financial Results
– Full year 2019 net revenues increased by 29% and operating loss decreased by
– Neos RxConnect rapidly expanded with ~500 pharmacies in network at year-end –
– NT0502 Phase 1 ascending dose trial initiation planned in 2H20 following top-line PK data –
– Company to host conference call today at
“We made tremendous strides in 2019, following the reset of our commercial strategy for our ADHD portfolio, which resulted in an improvement to the financial foundation of the company. In particular, we realized a 29% increase in net revenues for the full year of 2019 compared to 2018 and through our focus on operational productivity and expense management, we reduced our operating loss by approximately
ADHD Commercial Franchise
- Increased net revenue per pack by over 30 percent: Neos reported growth in net product sales and net revenue per pack for its two core commercial attention deficit hyperactivity disorder (ADHD) products, Adzenys XR-ODT® and Cotempla XR-ODT®, for the three months ended
December 31, 2019 compared to the same period in 2018.
| Net Revenue per Pack | ||||||
| Q4 2019 | Q4 2018 | % Change | ||||
| Adzenys XR-ODT | 32% | |||||
| Cotempla XR-ODT | 33% | |||||
- Strong growth in Neos RxConnect patient support program: During the fourth quarter of 2019, the company substantially expanded the number of participating pharmacies in the Neos RxConnect network to approximately 500 pharmacies, including one regional pharmacy chain, as of
December 31, 2019 . In mid-March, the company added a second regional pharmacy chain with approximately 250 pharmacies to the network, and it remains in active discussions with a number of other regional pharmacies strategically aligned in Neos territories. - Planned 2Q 2020 commercial launch of ADHD portfolio in
Puerto Rico : Neos recently entered into an agreement with a third-party to commercialize Neos’ ADHD portfolio inPuerto Rico . The commercial launch is anticipated to occur in the second quarter of 2020.
Advancing Clinical Pipeline
- Phase 1 pilot pharmacokinetic top-line data for NT0502: The company has completed a Phase 1 pilot study evaluating the pharmacokinetic profile of multiple formulations of NT0502 in 30 healthy adult volunteers. The top-line data confirms a formulation for further clinical development.
- NT0502 Phase 1 ascending dose trial to begin in second half of 2020: The company plans to initiate a Phase 1 clinical trial of NT0502 in the second half of 2020. The multi-part study will include single ascending and multiple ascending dose cohorts.
Financial Highlights and Select Financial Results
- For the fourth quarter of 2019, net loss narrowed to
$3.5 million , down from$9.3 million in the fourth quarter of 2018, reflecting the evolution of the commercial strategy and the company’s focus on both operational productivity and expense management. - Total product revenues were
$16.8 million for the three months endedDecember 31, 2019 , compared to$15.4 million for the same period in 2018. For the fiscal year endedDecember 31, 2019 , total product revenues were$64.6 million , compared to$50.0 million for the fiscal year endedDecember 31, 2018 .
| Fourth Quarter | Fiscal Year | ||||||||
| 2019 | 2018 | % Change |
2019 | 2018 | % Change |
||||
| Adzenys XR-ODT | 4.9 | % | 173 | % | |||||
| Cotempla XR-ODT | 0 | % | 34.7 | % | |||||
| Adzenys ER | * | * | * | * | |||||
| Generic Tussionex | 35.7 | % | 62.8 | % | |||||
| Total | 9.1 | % | 29.2 | % | |||||
| * Adzenys ER revenue was negligible in Q4 and fiscal year 2018. | |||||||||
- Gross profit was
$9.7 million for the three months endedDecember 31, 2019 , compared to$7.6 million for the same period in 2018. For the fiscal year endedDecember 31, 2019 , gross profit was$39.5 million , compared to$23.1 million for the fiscal year endedDecember 31, 2018 . - Research and development expenses were
$1.8 million for the three months endedDecember 31, 2019 , compared to$2.4 million for the same period in 2018. For the fiscal year endedDecember 31, 2019 , research and development expenses were$8.6 million , compared to$8.5 million for the fiscal year endedDecember 31, 2018 . - Selling and marketing expenses were
$6 .7 million for the three months endedDecember 31, 2019 , compared to$9 .1 million for the same period in 2018. For the fiscal year endedDecember 31, 2019 , selling and marketing expenses were$28.1 million , compared to$44.1 million for the fiscal year endedDecember 31, 2018 . - General and administrative expenses were
$2.9 million for the three months endedDecember 31, 2019 , compared to$3.3 million for the same period in 2018. For the fiscal year endedDecember 31, 2019 , general and administrative expenses were$13.2 million , compared to$13.9 million for the fiscal year endedDecember 31, 2018 . - Net loss for the three months ended
December 31, 2019 was$3.5 million , or$0.07 per share, compared to a net loss of$9.3 million , or$0.23 per share, for the same period in 2018. For the fiscal year endedDecember 31, 2019 , net loss was$16.9 million , or$0.34 per share, compared to a net loss of$51.7 million , or$1.60 per share for the fiscal year endedDecember 31, 2018 . - At
December 31, 2019 , the company held$24.9 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
About
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, commercial products, clinical development of its therapeutic candidates, plans for potential future product candidates, financial condition and outlook, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the net sales, profitability, and growth of the Company’s commercial products, including the Company’s confidence in the outlook for 2020 and beyond, the Company’s future expansion of the Neos RxConnect network and the expected launch of the Company’s ADHD products in
Neos Therapeutics, Inc. and Subsidiaries
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
(unaudited)
| 2019 | 2018 | |||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 16,830 | $ | 46,478 | ||||
| Short-term investments | 8,064 | — | ||||||
| Accounts receivable, net of allowances for chargebacks and cash discounts of |
26,563 | 27,801 | ||||||
| Inventories | 11,010 | 10,367 | ||||||
| Prepaid expenses and other current assets | 4,092 | 4,032 | ||||||
| Total current assets | 66,559 | 88,678 | ||||||
| Property and equipment, net | 7,345 | 7,914 | ||||||
| Operating lease right-of-use assets | 3,044 | — | ||||||
| Intangible assets, net | 12,543 | 14,616 | ||||||
| Other assets | 1,382 | 149 | ||||||
| Total assets | $ | 90,873 | $ | 111,357 | ||||
| LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 6,650 | $ | 12,730 | ||||
| Accrued expenses | 40,188 | 35,818 | ||||||
| Current portion of operating lease liabilities | 681 | — | ||||||
| Current portion of long-term debt | 15,836 | 8,557 | ||||||
| Total current liabilities | 63,355 | 57,105 | ||||||
| Long-Term Liabilities: | ||||||||
| Long-term debt, net of current portion | 29,099 | 43,217 | ||||||
| Operating lease liabilities | 3,254 | — | ||||||
| Derivative liability | 1,135 | 2,017 | ||||||
| Deferred rent | — | 989 | ||||||
| Other long-term liabilities | 160 | 184 | ||||||
| Total long-term liabilities | 33,648 | 46,407 | ||||||
| Stockholders' (Deficit) Equity: | ||||||||
| Preferred stock, |
— | — | ||||||
| Common stock, |
50 | 50 | ||||||
| (352 | ) | (352 | ) | |||||
| Additional paid-in capital | 328,056 | 325,130 | ||||||
| Accumulated deficit | (333,885 | ) | (316,983 | ) | ||||
| Accumulated other comprehensive income | 1 | — | ||||||
| Total stockholders' (deficit) equity | (6,130 | ) | 7,845 | |||||
| Total liabilities and stockholders' (deficit) equity | $ | 90,873 | $ | 111,357 | ||||
Neos Therapeutics, Inc. and Subsidiaries
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
(unaudited)
| Three Months Ended | Year Ended | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Revenues: | ||||||||||||||||
| Net product sales | $ | 16,832 | $ | 15,393 | $ | 64,649 | $ | 49,988 | ||||||||
| Cost of goods sold | 7,181 | 7,763 | 25,123 | 26,928 | ||||||||||||
| Gross profit | 9,651 | 7,630 | 39,526 | 23,060 | ||||||||||||
| Research and development expenses | 1,825 | 2,399 | 8,582 | 8,508 | ||||||||||||
| Selling and marketing expenses | 6,659 | 9,140 | 28,122 | 44,133 | ||||||||||||
| General and administrative expenses | 2,882 | 3,327 | 13,237 | 13,915 | ||||||||||||
| Loss from operations | (1,715 | ) | (7,236 | ) | (10,415 | ) | (43,496 | ) | ||||||||
| Interest expense | (2,038 | ) | (2,262 | ) | (8,009 | ) | (8,974 | ) | ||||||||
| Other income, net | 276 | 161 | 1,533 | 795 | ||||||||||||
| Loss before income taxes | (3,477 | ) | (9,337 | ) | (16,891 | ) | (51,675 | ) | ||||||||
| Income tax expense (benefit) | 11 | — | 11 | — | ||||||||||||
| Net loss | $ | (3,488 | ) | $ | (9,337 | ) | $ | (16,902 | ) | $ | (51,675 | ) | ||||
| Weighted average common shares outstanding used to compute net loss per share, basic and diluted | 49,732,654 | 41,415,358 | 49,723,772 | 32,288,555 | ||||||||||||
| Net loss per share of common stock, basic and diluted | $ | (0.07 | ) | $ | (0.23 | ) | $ | (0.34 | ) | $ | (1.60 | ) | ||||
Contacts:
Chief Financial Officer
(972) 408‑1389
reisenstadt@neostx.com
Stern Investor Relations, Inc.
(212) 362‑1200
sarah.mccabe@sternir.com
Source: Neos Therapeutics, Inc.