Press Release
Arena Announces Management and Program Updates and Reports Fourth Quarter and Full-Year 2019 Financial Results
"As we continue to execute on near and mid-term operational objectives, including delivering up to eight major data readouts between 2020 and 2021, we must also make the bold, strategic moves necessary to unlock the critical value that we believe our pipeline holds," said
"I have been tremendously privileged to have joined the company three years ago with the charter to reset Arena and deliver long-term shareholder value," said Mr. Lind "I am excited to continue that mission by further leveraging the significant potential value of Arena's world-class GPCR discovery research in the area of neuroscience. We believe Arena Neuroscience has an opportunity to expand treatment options in a therapeutic area where there is an urgent unmet need for patients."
"Laurie is an accomplished executive with significant financial expertise across both emerging and established biotechnology companies and will be an exceptional addition to our management team," said
Program Updates:
- Etrasimod ELEVATE UC 52 Phase 3 trial in ulcerative colitis (UC) ongoing; ELEVATE UC 12 Phase 3 trial expected to initiate at a later date
- Etrasimod CULTIVATE Phase 2b dose-ranging trial in Crohn's disease (CD) initiated and ongoing
- Etrasimod eosinophilic esophagitis (EoE) Phase 2b and alopecia areata (AA) Phase 2 planning ongoing, initiation expected this year
- Etrasimod atopic dermatitis (AD) ADVISE Phase 2b trial ongoing; data expected H2 2020
- Olorinab CAPTIVATE Phase 2b trial in abdominal pain associated with irritable bowel syndrome
- (IBS-C, IBS-D) ongoing; data expected H2 2020
- APD418 in acute heart failure (AHF) Phase 1 trial ongoing; Fast Track designation granted
Financial Update
Fourth Quarter 2019 Financial Results
- Revenues totaled
$3.0 million , primarily consisting of $5.0 million of development milestone revenue from Everest offset by a reduction of estimated future royalties from BELVIQ sales - Research and development expenses totaled
$74.6 million , including$7.0 million related to non-cash share-based compensation - General and administrative expenses totaled
$22.2 million , including$6.3 million related to non-cash share-based compensation - Net loss was
$88.3 million or$1.76 per share
Full-Year 2019 Financial Results
- Revenues totaled
$806.4 million , primarily consisting of$800.0 million of revenue from the United Therapeutics upfront payment - Research and development expenses totaled
$231.5 million , including$27.4 million related to non-cash share-based compensation - General and administrative expenses totaled
$77.6 million , including$25.7 million related to non-cash share-based compensation - Income tax provision was
$110.3 million as a result of utilizing the deferred tax assets that were recorded in the fourth quarter of 2018 - Net income was
$397.6 million , or$7.99 per share
At
Conference Call & Webcast Information
Arena will host a conference call and live webcast with the investment community today,
When:
Dial-in: (877) 643-7155 (
Conference ID: 8286947
Please join the conference call at least 10 minutes early to register. You can access the live webcast under the investor relations section of Arena's website at: www.arenapharm.com. A replay of the conference call will be archived under the investor relations section of Arena's website for 30 days shortly after the call.
About
It is the breadth and depth of our portfolio, prioritization of drug development to meet unmet patient needs, strong financial health and growing, bold-thinking world-class team that gives Arena the ingredients and passion to build a sustainable, vibrant next generation pharmaceutical company.
Etrasimod, olorinab and APD418 are investigational compounds that are not approved for any use in any country.
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements may be identified by words such as "expects," "objectives," "believe," "excited to," "potential," "will," "confident in," "planning," "estimated," and "uniquely positioned to" and include, without limitation, statements about the following: Arena's planned conference call and webcast with the investment community; design, initiation, enrollment, data and results, and timing relating to ongoing and intended programs and studies, including the timing of planned IND filings, initiation of planned clinical trials, and timing of data readouts; the potential of Arena's drug candidates, including to be first- or best-in-class, world-class, or best-in disease, have optimized efficacy and safety, have critical value, and satisfy an unmet need; the potential of Arena Neuroscience; and Arena's position, drive, portfolio, prioritization, financial position, team, and building of the company. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the following: clinical trials and other studies may not proceed at the time or in the manner expected or at all; the timing and outcome of research, development and regulatory review is uncertain, and Arena's drug candidates may not advance in development or be approved for marketing; enrolling patients in Arena's ongoing and intended clinical trials is competitive and challenging; Fast Track designation may not result in an expedited regulatory review process; risks related to developing and commercializing drugs; Arena may need additional funds to advance all of its programs, and you and others may not agree with the manner Arena allocates its resources; risks and uncertainties relating to cash and revenues that may be generated from product sales or other sources, including the impact of competition; Arena's revenues are based in part on estimates, judgment and accounting policies, and incorrect estimates or disagreement regarding estimates or accounting policies may result in changes to Arena's guidance or previously reported results; risks related to unexpected or unfavorable new data; nonclinical and clinical data is voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; topline data may not accurately reflect the complete results of a particular study or trial; satisfactory resolution of litigation or other disagreements with others; government and third-party payor actions, including relating to reimbursement and pricing; risks related to relying on licenses or collaborative arrangements, including lack of control and potential disputes; the entry into or modification or termination of licenses or collaborative arrangements; and Arena's and third parties' intellectual property rights. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the
Corporate Contact:
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Arena Media Contact:
IR@arenapharm.com
858-453-7200
(Tables Follow)
Condensed Consolidated Statements of Operations (In thousands, except per share amounts) |
||||||||||||||||
Three months ended |
Year ended |
|||||||||||||||
|
|
|||||||||||||||
2019 |
2018 |
2019 |
2018 |
|||||||||||||
(unaudited) |
||||||||||||||||
Revenues |
||||||||||||||||
United Therapeutics revenue |
$ |
— |
$ |
— |
$ |
800,000 |
$ |
— |
||||||||
Collaboration and other revenue |
6,580 |
6,878 |
7,284 |
11,402 |
||||||||||||
Royalty revenue |
(3,578) |
1,770 |
(853) |
6,568 |
||||||||||||
Total revenues |
3,002 |
8,648 |
806,431 |
17,970 |
||||||||||||
Operating Costs & Expenses |
||||||||||||||||
Research & development |
74,632 |
37,890 |
231,496 |
115,029 |
||||||||||||
General & administrative |
22,243 |
12,935 |
77,616 |
45,257 |
||||||||||||
Transaction costs |
— |
2,467 |
14,573 |
2,467 |
||||||||||||
Total operating costs & expenses |
96,875 |
53,292 |
323,685 |
162,753 |
||||||||||||
Income (loss) from operations |
(93,873) |
(44,644) |
482,746 |
(144,783) |
||||||||||||
Total interest & other income (expense), net |
5,562 |
3,090 |
25,142 |
5,949 |
||||||||||||
Income (loss) from continuing operations before income taxes |
(88,311) |
(41,554) |
507,888 |
(138,834) |
||||||||||||
Income tax (provision) benefit |
— |
110,265 |
(110,333) |
110,265 |
||||||||||||
Income (loss) from continuing operations |
(88,311) |
68,711 |
397,555 |
(28,569) |
||||||||||||
Loss from discontinued operations |
— |
— |
— |
(830) |
||||||||||||
Net income (loss) |
$ |
(88,311) |
$ |
68,711 |
$ |
397,555 |
$ |
(29,399) |
||||||||
Net income (loss) per share, basic: |
||||||||||||||||
Continuing operations |
$ |
(1.76) |
$ |
1.39 |
$ |
7.99 |
$ |
(0.61) |
||||||||
Discontinued operations |
— |
— |
— |
(0.02) |
||||||||||||
$ |
(1.76) |
$ |
1.39 |
$ |
7.99 |
$ |
(0.63) |
|||||||||
Net income (loss) per share, diluted: |
||||||||||||||||
Continuing operations |
$ |
(1.76) |
$ |
1.35 |
$ |
7.69 |
$ |
(0.61) |
||||||||
Discontinued operations |
— |
— |
— |
(0.02) |
||||||||||||
$ |
(1.76) |
$ |
1.35 |
$ |
7.69 |
$ |
(0.63) |
|||||||||
Shares used in calculating net income (loss) per share, basic: |
50,113 |
49,409 |
49,779 |
47,041 |
||||||||||||
Shares used in calculating net income (loss) per share, diluted: |
50,113 |
50,826 |
51,698 |
47,041 |
Condensed Consolidated Balance Sheet Data (In thousands) (Unaudited) |
||||||||
|
|
|||||||
1 |
1 |
|||||||
Assets |
||||||||
Cash & cash equivalents |
$ |
243,274 |
$ |
161,037 |
||||
Accounts receivable |
1,654 |
5,086 |
||||||
Deferred tax assets |
— |
110,333 |
||||||
Prepaid expenses & other current assets |
18,715 |
10,008 |
||||||
Total available-for-sale investments |
867,229 |
367,006 |
||||||
Land, property & equipment, net |
25,128 |
23,114 |
||||||
Other non-current assets |
18,123 |
10,319 |
||||||
Total assets |
$ |
1,174,123 |
$ |
686,903 |
||||
Liabilities & Stockholders' Equity |
||||||||
Accounts payable & accrued liabilities |
$ |
41,153 |
$ |
26,635 |
||||
Total lease financing obligations & other long-term liabilities |
61,505 |
54,010 |
||||||
Total stockholders' equity |
1,071,465 |
606,258 |
||||||
Total liabilities & stockholders' equity |
$ |
1,174,123 |
$ |
686,903 |
1 The Condensed Consolidated Balance Sheet Data has been derived from the audited financial statements as of that date. |
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