EX-99.1 2 arna-ex991_6.htm EX-99.1 arna-ex991_6.htm

Exhibit 99.1

 

 

 

 

 

Arena Reports Second Quarter Financial Results with Strong Liquidity Position, and Initiation of Etrasimod ELEVATE UC 52 and Olorinab CAPTIVATE Trials

 

 

Etrasimod initiation of the Phase 3 ELEVATE UC 52 global trial in ulcerative colitis (UC)

 

Olorinab initiation of the Phase 2 CAPTIVATE clinical trial in abdominal pain associated with irritable bowel syndrome (IBS)

 

Multiple first- or best-in-class drug candidates, skilled leadership team and liquidity position of over $1.2 billion

 

 

SAN DIEGO, Calif., August 7, 2019 - Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today provided a corporate update and reported financial results for the second quarter ended June 30, 2019.

 

“Arena is off to a strong 2019 and we remain highly focused on achieving several key clinical and regulatory goals. We are excited to have recently initiated two important trials, the etrasimod Phase 3 ELEVATE UC 52 trial and the olorinab Phase 2 CAPTIVATE trial. We will provide further detail around the CAPTIVATE trial on today’s call,” said Amit D. Munshi, President and CEO of Arena. “Execution is key for Arena this year, following several positive data readouts and strategic transactions across our pipeline.  We look forward to demonstrating the potential benefits and differentiation of our first- or best-in-class assets as we continue to deliver these exciting milestones.”

 

Pipeline Update

 

Etrasimod – Next generation, once-daily, oral, selective sphingosine-1-phosphate (S1P) receptor modulator in development for the treatment of multiple immune and inflammatory diseases

 

 

Ulcerative colitis (UC): The global Phase 3 ELEVATE UC registrational program will consist of two key trials to evaluate etrasimod 2 mg in subjects with moderately to severely active UC

 

o

ELEVATE UC 52, a treat-through trial with a 12-week induction period followed by 40 weeks of maintenance; trial was initiated in June

 

o

ELEVATE UC 12, a 12-week trial, which is expected to initiate at a later date to optimize speed to market

 

 

Crohn’s disease (CD):

 

o

CULTIVATE Phase 2b/3 program planning ongoing

 

 

Atopic dermatitis (AD):

 

o

ADVISE Phase 2b trial planning ongoing

 


Olorinab – Oral, peripherally acting, highly selective, full agonist of cannabinoid type 2 receptor (CB2) in development for the treatment of visceral pain associated with gastrointestinal (GI) diseases

 

 

Abdominal pain associated with irritable bowel syndrome (IBS):

 

o

CAPTIVATE is a Phase 2b trial to evaluate three dose levels of olorinab for 12-weeks in approximately 240 subjects experiencing abdominal pain associated with IBS, including IBS with constipation (IBS-C) and IBS with diarrhea (IBS-D). The primary endpoint will measure the improvement from baseline in the weekly Average Abdominal Pain Scale (AAPS); trial was initiated in July

 

Etrasimod and olorinab are investigational compounds that are not approved for any use in any country.

 

Financial Update

 

Second Quarter 2019 Financial Results

 

Revenues totaled $1.0 million, primarily consisting of $0.9 million of royalty revenue

 

Research and development expenses totaled $51.2 million, including $7.0 million related to non-cash share-based compensation

 

General and administrative expenses totaled $18.4 million, including $6.4 million related to non-cash share-based compensation

 

Net loss was $61.4 million or $1.24 per share

 

At June 30, 2019, Arena’s cash, cash equivalents and investments balance was over $1.2 billion and approximately 49.8 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, August 7, 2019, at 4:30 PM EDT to discuss the financial results and provide a corporate update.

 

When: Wednesday, August 7, 2019, at 4:30 PM EDT

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

Conference ID: 4673427

 

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. Etrasimod (APD334), with potential utility in a broad range of immune and inflammatory conditions, is being evaluated in late-stage clinical programs in ulcerative colitis (UC) and Crohn's disease (CD), as well as in programs for other indications such as 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.

 


Arena has additional license agreements and partnerships, including with United Therapeutics (ralinepag in a Phase 3 program for pulmonary arterial hypertension), Everest Medicines Limited (etrasimod in Greater China and select Asian countries), 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 “expected,” “potential,” “plan,” “in development for,” “will,” “driven to,” “evaluate,” “look forward to,” and include, without limitation, statements about the following: design, initiation, enrollment, data and results, and timing relating to ongoing and intended trials; the potential of Arena’s drug candidates, including to be first- or best-in-class, have optimized pharmacology and pharmacokinetics, have broad clinical utility, and be delivered to patients globally; Arena’s position and ability to execute on its programs; Arena’s drive and focus; and the potential of Arena’s assets, programs, licenses, and collaborations. 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; 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 Securities and Exchange Commission (SEC), including but not limited to Arena’s Annual Report on Form 10-K for the year ended December 31, 2018, which was filed with the SEC on February 28, 2019, and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2019, which was filed with the SEC on May 9, 2019. 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, MD

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

 

 

Six months ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

 

(unaudited)

 

 

(unaudited)

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

United Therapeutics revenue

 

$

 

 

$

 

 

$

800,000

 

 

$

 

Royalty revenue

 

 

941

 

 

 

861

 

 

 

1,914

 

 

 

1,588

 

Collaboration and other revenue

 

 

81

 

 

 

  3,133

 

 

 

165

 

 

 

4,161

 

Total revenues

 

 

1,022

 

 

 

3,994

 

 

 

802,079

 

 

 

5,749

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating Costs & Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research & development

 

 

51,211

 

 

 

26,755

 

 

 

96,607

 

 

 

48,328

 

General & administrative

 

 

18,367

 

 

 

10,405

 

 

 

34,945

 

 

 

21,556

 

Transaction costs

 

 

 

 

 

 

 

 

14,573

 

 

 

 

Total operating costs & expenses

 

 

69,578

 

 

 

37,160

 

 

 

146,125

 

 

 

69,884

 

Income (loss) from operations

 

 

(68,556

)

 

 

(33,166

)

 

 

655,954

 

 

 

(64,135

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total interest & other income (expense), net

 

 

7,153

 

 

 

1,333

 

 

 

13,110

 

 

 

1,169

 

Income (loss) from continuing operations before income taxes

 

 

(61,403

)

 

 

(31,833

)

 

 

669,064

 

 

 

(62,966

)

Income tax provision

 

 

 

 

 

 

 

 

(110,333

)

 

 

 

Income (loss) from continuing operations

 

 

(61,403

)

 

 

(31,833

)

 

 

558,731

 

 

 

(62,966

)

Loss from discontinued operations

 

 

 

 

 

 

 

 

 

 

 

(830

)

Net income (loss)

 

$

(61,403

)

 

$

(31,833

)

 

$

558,731

 

 

$

(63,796

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share, basic:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Continuing operations

 

$

(1.24

)

 

$

(0.65

)

 

$

11.27

 

 

$

(1.41

)

Discontinued operations

 

 

 

 

 

 

 

 

 

 

 

(0.02

)

 

 

$

(1.24

)

 

$

(0.65

)

 

$

11.27

 

 

$

(1.43

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share, diluted:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Continuing operations

 

$

(1.24

)

 

$

(0.65

)

 

$

10.86

 

 

$

(1.41

)

Discontinued operations

 

 

 

 

 

 

 

 

 

 

 

(0.02

)

 

 

$

(1.24

)

 

$

(0.65

)

 

$

10.86

 

 

$

(1.43

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares used in calculating net income (loss) per share, basic:

 

 

49,653

 

 

 

49,263

 

 

 

49,566

 

 

 

44,655

 

Shares used in calculating net income (loss) per share, diluted:

 

 

49,653

 

 

 

49,263

 

 

 

51,459

 

 

 

44,655

 

 


Arena Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheet Data

(In thousands)

 

 

 

 

June 30, 2019

 

 

December 31, 2018

 

 

 

 

(unaudited)

 

 

 

(unaudited)1

 

Assets

 

 

 

 

 

 

 

 

Cash & cash equivalents

 

$

200,059

 

 

$

161,037

 

Accounts receivable

 

 

1,824

 

 

 

5,086

 

Deferred tax assets

 

 

 

 

 

110,333

 

Prepaid expenses & other current assets

 

 

20,778

 

 

 

10,008

 

Total available-for-sale investments

 

 

1,021,855

 

 

 

367,006

 

Land, property & equipment, net

 

 

23,493

 

 

 

23,114

 

Other non-current assets

 

 

16,526

 

 

 

10,319

 

Total assets

 

$

1,284,535

 

 

$

686,903

 

 

 

 

 

 

 

 

 

 

Liabilities & Stockholders’ Equity

 

 

 

 

 

 

 

 

Accounts payable & accrued liabilities

 

$

24,637

 

 

$

26,635

 

Total lease financing obligations & other long-term liabilities

 

 

58,909

 

 

 

54,010

 

Total stockholders’ equity

 

 

1,200,989

 

 

 

606,258

 

Total liabilities & stockholders’ equity

 

$

1,284,535

 

 

$

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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