Press Release
Arena Pharmaceuticals Provides Corporate Update and Reports Third Quarter 2018 Financial Results
"Our recent positive results from the Phase 2a trial of olorinab in pain associated with Crohn's disease and the ralinepag PAH open-label extension trial further demonstrate the strength of Arena's pipeline and the ability of the Company to execute on these potentially transformative programs," said
Pipeline Update
Etrasimod – Next generation, oral, selective sphingosine-1-phosphate (S1P) receptor modulator intended for the potential treatment of multiple immune and inflammatory diseases
- Ulcerative colitis (UC):
- Phase 3 planning ongoing
- Crohn's disease (CD):
- Regulatory discussions and Phase 2/3 planning ongoing
- Primary biliary cholangitis (PBC):
- Phase 2 trial ongoing
- Atopic dermatitis (AD):
- Program planning ongoing
Ralinepag – Next generation, oral, once-daily, selective prostacyclin receptor agonist intended for the potential treatment of pulmonary arterial hypertension (PAH)
- Advancing PAH Phase 3 clinical program
- Delivered positive open-label extension interim trial results
- Demonstrated durable, long-term improvements in both pulmonary vascular resistance (PVR) and 6-minute walk distance (6MWD)
- Favorable long-term tolerability profile demonstrated
Olorinab – Peripherally restricted, oral, full agonist of the cannabinoid receptor 2 (CB2) intended for the potential treatment of visceral pain, specifically pain associated with Crohn's disease
- Delivered positive Phase 2a data in pain associated with Crohn's disease
- Demonstrated a statistically significant improvement in abdominal pain over 8 weeks of treatment
- All patients with evaluable data at week 8 exhibited a pre-defined clinical response of ≥30% change from baseline in Average Abdominal Pain Score (AAPS)
- Treatment effects were demonstrated early and were consistent over the 8-week treatment period
- Appeared safe and generally well tolerated
- Phase 2b clinical program targeting the treatment of gastrointestinal pain being developed
APD418 (preclinical) - First-in-Class Calcium-Independent Myofilament Derepressor (CMD) for the treatment of decompensated heart failure (DHF)
- Targets a novel mechanism that improves contractility without adverse hemodynamic changes
- DHF is an area of high unmet medical need with significant morbidity and mortality
- New preclinical data to be presented at
American Heart Association (AHA) Scientific Sessions
Collaboration Update
- In
October 2018 , Everest Medicines receivedChina Food andDrug Administration (CFDA) Investigational New Drug approval for ralinepag
Corporate Update
- In
August 2018 , Arena appointedSuzanne Zoumaras as Executive Vice President and Chief Human Resources Officer
Financial Update
Third Quarter 2018 Financial Results
- Revenues totaled
$3.6 million , consisting of$3.2 million in royalty revenue and$0.4 million in collaboration revenue - Research and development expenses totaled
$28.8 million - General and administrative expenses totaled
$10.8 million - Net loss attributable to stockholders of Arena was
$34.3 million , or$0.70 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: 1993206
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
In addition, Arena has several partnerships including with
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 "demonstrate," "potentially," "excited to," "focus on," "intended for," "potential," "planning," "appear," "targeting," "targets," "to be presented," "will," "driven to," "being evaluated for," and "evaluating for," and include, without limitation, statements about the following: design, initiation, enrollment, results, data readouts, data presentations, and timing relating to ongoing and intended preclinical and clinical trials; the potential of Arena's drug candidates, including to be best-in-class or transformative, have broad clinical utility, and be delivered to patients with high unmet need; the strength of Arena's pipeline; Arena's ability to execute on its programs; Arena's investment community conference call and webcast; and Arena's focus, goals, strategy, preclinical and clinical programs, and collaborators. 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: 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 related to developing and commercializing drugs; enrolling patients in Arena's ongoing and intended clinical trials is competitive and challenging; 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; 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 collaborative arrangements; the entry into or modification or termination of 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
Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
(Tables Follow)
Arena Pharmaceuticals, Inc. Condensed Consolidated Statements of Operations (In thousands, except per share amounts) |
|||||||
Three months ended |
Nine months ended |
||||||
September 30, |
September 30, |
||||||
2018 |
2017 |
2018 |
2017 |
||||
(unaudited) |
(unaudited) |
||||||
Revenues |
|||||||
Collaboration and other revenue |
$ 363 |
$ 1,881 |
$ 4,524 |
$ 5,439 |
|||
Royalty revenue |
3,210 |
534 |
4,798 |
534 |
|||
Total revenues |
3,573 |
2,415 |
9,322 |
5,973 |
|||
Operating Costs & Expenses |
|||||||
Research & development |
28,811 |
17,233 |
77,139 |
50,277 |
|||
General & administrative |
10,766 |
7,418 |
32,322 |
22,088 |
|||
Litigation settlement expense, net |
— |
11,975 |
— |
11,975 |
|||
Total operating costs & expenses |
39,577 |
36,626 |
109,461 |
84,340 |
|||
Total interest & other income (expense), net |
1,690 |
(1,059) |
2,859 |
(3,217) |
|||
Loss from continuing operations |
(34,314) |
(35,270) |
(97,280) |
(81,584) |
|||
Income (loss) from discontinued operations |
— |
2,606 |
(830) |
2,807 |
|||
Net loss |
(34,314) |
(32,664) |
(98,110) |
(78,777) |
|||
Less net loss attributable to noncontrolling interest in consolidated variable interest entity |
— |
311 |
— |
1,054 |
|||
Net loss attributable to stockholders of Arena |
$ (34,314) |
$ (32,353) |
$ (98,110) |
$ (77,723) |
|||
Amounts attributable to stockholders of Arena: |
|||||||
Loss from continuing operations |
$ (34,314) |
$ (34,959) |
$ (97,280) |
$ (80,530) |
|||
Income (loss) from discontinued operations |
— |
2,606 |
(830) |
2,807 |
|||
$ (34,314) |
$ (32,353) |
$ (98,110) |
$ (77,723) |
||||
Net income (loss) attributable to stockholders of Arena per share, basic and diluted: |
|||||||
Continuing operations |
$ (0.70) |
$ (0.93) |
$ (2.10) |
$ (2.32) |
|||
Discontinued operations |
— |
0.07 |
(0.02) |
0.08 |
|||
$ (0.70) |
$ (0.86) |
$ (2.12) |
$ (2.24) |
||||
Shares used in calculating net income (loss) attributable to stockholders of Arena per share, basic and diluted: |
49,368 |
37,766 |
46,243 |
34,692 |
|||
Arena Pharmaceuticals, Inc. |
|||
Condensed Consolidated Balance Sheet Data |
|||
(In thousands) |
|||
(unaudited) |
|||
September 30, 2018 |
December 31, 2017 |
||
1 |
|||
Assets |
|||
Cash & cash equivalents |
$ 508,663 |
$ 158,837 |
|
Accounts receivable |
1,329 |
2,357 |
|
Insurance recovery receivable |
— |
12,025 |
|
Prepaid expenses & other current assets |
9,524 |
2,681 |
|
Total available for sale investments |
52,961 |
112,482 |
|
Land, property & equipment, net |
27,836 |
30,131 |
|
Other non-current assets |
9,721 |
3,622 |
|
Assets of disposal group held for sale |
— |
17,140 |
|
Total assets |
$ 610,034 |
$ 339,275 |
|
Liabilities & Stockholders' Equity |
|||
Accounts payable & accrued liabilities |
$ 17,768 |
$ 15,622 |
|
Accrued litigation settlement |
— |
24,000 |
|
Total deferred revenues |
1,215 |
2,177 |
|
Total lease financing obligations & other long-term liabilities |
59,735 |
62,737 |
|
Liabilities of disposal group held for sale |
— |
27,595 |
|
Total stockholders' equity |
531,316 |
207,144 |
|
Total liabilities & stockholders' equity |
$ 610,034 |
$ 339,275 |
1 |
The Condensed Consolidated Balance Sheet Data has been derived from the audited financial statements as of that date. |

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