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8-K - 8-K - ARENA PHARMACEUTICALS INCarna-8k_20181107.htm

Exhibit 99.1

 

 

 

 

Arena Pharmaceuticals Provides Corporate Update and Reports Third Quarter 2018 Financial Results

 

 

Ralinepag open-label extension data demonstrated durable, long-term improvements in both PVR and 6MWD

 

Olorinab positive Phase 2a data for the treatment of pain associated with Crohn’s disease; all patients with evaluable data at week 8 exhibited a pre-defined clinical improvement

 

 

SAN DIEGO, November 7, 2018 -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today provided a corporate update and reported financial results for the third quarter ended September 30, 2018.

 

"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 Amit D. Munshi, President and CEO of Arena. "The achievement of positive Phase 2 results from olorinab, ralinepag and etrasimod in ulcerative colitis puts Arena in an extremely strong operating position.  Moreover, we are excited to introduce a novel cardiopulmonary compound, APD418, in development for the treatment of decompensated heart failure. We continue to focus on delivering multiple best-in-class compounds in areas of high unmet need to patients as expeditiously as possible.”

 

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):

 

o

Phase 3 planning ongoing

 

Crohn’s disease (CD):

 

o

Regulatory discussions and Phase 2/3 planning ongoing

 

Primary biliary cholangitis (PBC):

 

o

Phase 2 trial ongoing

 

Atopic dermatitis (AD):

 

o

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

 

o

Demonstrated durable, long-term improvements in both pulmonary vascular resistance (PVR) and 6-minute walk distance (6MWD)

 

o

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 received China Food and Drug Administration (CFDA) Investigational New Drug approval for ralinepag

 

Corporate Update

 

 

In August 2018, Arena appointed Suzanne 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 September 30, 2018, Arena’s cash, cash equivalents and investments balance was $561.6 million and approximately 49.4 million shares of Arena common stock were outstanding.

 

Conference Call & Webcast Information

Arena will host a conference call and live webcast with the investment community today, Wednesday, November 7, 2018, at 4:30 p.m. EST to discuss the financial results and provide a corporate update.

 

When: Wednesday, November 7, 2018, at 4:30 p.m. EST

Dial-in: (877) 643-7155 (United States) or (914) 495-8552 (International)

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 Arena Pharmaceuticals

Arena Pharmaceuticals is driven to deliver novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena’s proprietary pipeline includes multiple potentially first- or best-in-class assets with broad clinical utility. Ralinepag (APD811) is being evaluated in a Phase 3 program for pulmonary arterial hypertension (PAH). Etrasimod (APD334), with potential utility in a broad range of immune and inflammatory conditions, is being evaluated in later-stage clinical programs in ulcerative colitis (UC) and Crohn’s disease, as well as progressing programs for primary biliary cholangitis (PBC) and atopic dermatitis. Arena is also evaluating olorinab (APD371) in a Phase 2 program for gastrointestinal pain. Arena continues to assess other earlier research and development stage drug candidates, including APD418 for decompensated heart failure.

 

In addition, Arena has several partnerships including with Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries), Axovant Sciences GmbH (nelotanserin - Phase 2), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), Outpost Medicine, LLC (undisclosed target – preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ® - marketed product).

 

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 Securities and Exchange Commission (SEC), including but not limited to Arena’s Annual Report on Form 10-K for the year ended December 31, 2017, which was filed with the SEC on March 14, 2018, and Arena’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, which was filed with the SEC on August 7, 2018. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

 

Corporate Contact:

Kevin R. Lind

Arena Pharmaceuticals, Inc.

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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