Arena Pharmaceuticals, Inc.
ARENA PHARMACEUTICALS INC (Form: 8-K, Received: 11/07/2017 16:05:26)

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 7, 2017

 

Arena Pharmaceuticals, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

000-31161

23-2908305

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

 

 

 

6154 Nancy Ridge Drive,

San Diego, CA

 

92121

(Address of Principal Executive Offices)

 

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (858) 453-7200

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

 

 

 

 


 

In this report, “Arena Pharmaceuticals,” “Arena,” “Company,” “we,” “us” and “our” refer to Arena Pharmaceuticals, Inc., and/or one or more of our wholly owned subsidiaries, unless the context otherwise provides. Arena Pharmaceuticals® and Arena® are regist ered service marks of Arena Pharmaceuticals, Inc.

Item 2.02 R e sults of O perat i o n s and Financial Con d itio n .

On November 7, 2017, we issued a press release report i ng our f i n a nc i al resul t s for t he third quar t er ended September 30, 2017. The f u ll t ext of the press re l ease is furnished as E x hi b it 99.1 t o th i s Current Rep o rt on Form 8-K.

Item 9.01 Financi a l Statements and Exh i b i ts. (d) E xhibits.

99.1

Press release issued November 7, 2017, rep o r t i n g f ina n c ia l res u lt s fo r th e third q ua r te r en d ed September 3 0, 2 0 17

 

 

 


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

Date: November 7, 2017

Arena Pharmaceuticals, Inc.

 

 

 

 

 

By:

 

/s/ Amit D. Munshi

 

 

 

Amit D. Munshi

 

 

 

President and Chief Executive Officer

 

 

 

 

Exhibit 99.1

 

 

 

 

Arena Pharmaceuticals Provides Corporate Update and Reports Third Quarter 2017 Financial Results

 

- Submitted Ralinepag FDA Meeting Request

- Expect to Complete Full Enrollment for Etrasimod Phase 2 Study in Ulcerative Colitis This Week

- Initiated Etrasimod Phase 2 Study in Primary Biliary Cholangitis

 

SAN DIEGO, November 7, 2017 -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA), today provided a corporate update and reported financial results for the third quarter ended September 30, 2017.

 

“We are pleased with the progress we achieved during the third quarter, hitting multiple milestones for our lead programs,” said Amit D. Munshi, President and CEO of Arena. “We remain highly focused on continuing to advance our lead programs and driving shareholder value. We look forward to meeting with the FDA about the Phase 3 program for ralinepag and reporting top-line Phase 2 data for etrasimod in ulcerative colitis and for APD371 in pain associated with Crohn’s disease.”

 

Pipeline Update

 

Ralinepag – Oral, selective, next generation IP receptor agonist targeting the prostacyclin pathway for the potential treatment of pulmonary arterial hypertension

 

Meeting request submitted to the FDA; Phase 3 clinical program preparations continue to progress

 

Etrasimod – Orally available next generation sphingosine-1-phosphate (S1P) receptor modulator for the potential treatment of a number of autoimmune diseases

 

Ulcerative colitis (UC):

 

o

Expect to complete enrollment of Phase 2 trial this week

 

o

Data expected Q1 2018

 

 

Primary biliary cholangitis (PBC):

 

 

o

Phase 2 study initiated

 

 

Pyoderma gangrenosum (PG):

 

 

o

Phase 2 trial currently enrolling patients

 

 

Dermatological extraintestinal manifestations (EIM):

 

 

o

Phase 2 study enrolled; intend to evaluate in combination with UC study

 

APD371 – Orally available full agonist of the cannabinoid-2 receptor for the potential treatment of visceral pain, specifically pain associated with Crohn’s disease

 

Phase 2 trial currently enrolling patients

 

Data expected Q1 2018

 

Collaborations Update

 

 

Nelotanserin - Axovant collaboration

 


 

o

Visual hallucinations in Lewy Body dementia (LBD):

 

Phase 2 data expected Q1 2018

 

 

o

REM sleep behavior disorder in subjects with LBD:

 

Phase 2 data expected Q2 2018

 

Corporate Update

 

 

Appointed Chris Cabell, M.D., MHS, FACC, as Senior Vice President, Clinical Development

 

 

Closed a public offering that raised aggregate net proceeds of $162.0 million through the issuance of approximately 7.2 million shares of common stock

 

 

Financial Update

 

Third Quarter 2017 Financial Results

 

Revenues totaled $7.9 million, including $3.1 million in net product sales of BELVIQ, $1.7 million in manufacturing support payments from Eisai, and approximately $1.9 million of revenue from Boehringer Ingelheim and Axovant collaborations

 

 

Research and development expenses totaled $17.3 million

 

 

General and administrative expenses totaled $7.8 million

 

Litigation settlement expense, net related to tentative settlement of the 2010 securities class action litigation totaled $12.0 million

 

 

Net loss was $32.4 million, or $0.86 per share

 

At September 30, 2017, cash and cash equivalents totaled $278.7 million, and approximately 39.3 million shares of Arena common stock were outstanding.

 

Conference Call & Webcast Information

The Company will host a conference call and live webcast with the investment community today, Tuesday, November 7, 2017, at 4:30 p.m. EST to discuss the financial results and provide a corporate update.

 

When: November 7, 2017, 4:30 p.m. EST

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

Conference ID: 1910287

 

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 a biopharmaceutical company focused on developing novel, small molecule drugs with optimized receptor pharmacology designed to deliver broad clinical utility across multiple therapeutic areas. Our proprietary pipeline includes potentially first- or best-in-class programs for which we own global commercial rights. Our three most advanced investigational clinical programs are ralinepag (APD811) which has completed a Phase 2 trial for pulmonary arterial hypertension (PAH), etrasimod (APD334) in Phase 2 evaluation for multiple autoimmune indications, and APD371 in Phase 2 evaluation for the treatment of pain associated with Crohn's disease. In addition, Arena has collaborations with the following


pharmaceutical companies: Eisai Co., Ltd. and Eisai Inc. (commercial stage), Axovant Sciences (Phase 2 can didate), and Boehringer Ingelheim International GmbH (preclinical candidate).

 

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 “expect”, “look forward to”, “preparations”, “intend”, “potential”, “will”, “may”, and similar words, and include, without limitation, statements about timing relating to ongoing or intended clinical trials, planned meetings with the FDA, patient enrollment in ongoing or intended clinical trials, advancement of our pipeline, expected results, anticipated data readouts, the significance of clinical data, shareholder value creation, and Arena’s focus, goals, strategy and clinical programs. 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:  the timing and outcome of research, development and regulatory review is uncertain; enrolling patients in our ongoing and intended clinical trials is competitive and challenging; we expect to need additional funds to advance all of our programs, and you and others may not agree with the manner we allocate our resources; our drug candidates may not advance in development or be approved for marketing; risks related to developing and commercializing drugs; the risk that 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; 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; unexpected or unfavorable new data; nonclinical and clinical data are 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; topline data may not accurately reflect the complete results of a particular study or trial; Arena's and third parties' intellectual property rights; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; clinical trials and other studies may not proceed at the time or in the manner expected or at all; and satisfactory resolution of litigation or other disagreements with others. 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. 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@lifescipublicrelations.com
646.627.8384

 


(Tables Follow)

 

 

 

 



Arena Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations

(In thousands, except per share amounts)

(unaudited)

 

 

 

Three months ended

 

 

Nine months ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

 

(unaudited)

 

 

(unaudited)

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net product sales

 

$

3,075

 

 

$

3,323

 

 

$

7,845

 

 

$

11,104

 

Other Eisai collaboration revenue

 

 

2,223

 

 

 

12,954

 

 

 

5,539

 

 

 

18,155

 

Other collaboration revenue

 

 

1,881

 

 

 

1,737

 

 

 

5,439

 

 

 

6,066

 

Toll manufacturing

 

 

769

 

 

 

1,228

 

 

 

2,241

 

 

 

3,276

 

Total revenues

 

 

7,948

 

 

 

19,242

 

 

 

21,064

 

 

 

38,601

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating Costs & Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product sales

 

 

1,739

 

 

 

882

 

 

 

5,768

 

 

 

4,161

 

Cost of toll manufacturing

 

 

1,222

 

 

 

1,930

 

 

 

3,215

 

 

 

4,876

 

Research & development

 

 

17,307

 

 

 

17,466

 

 

 

50,740

 

 

 

54,514

 

General & administrative

 

 

7,791

 

 

 

8,590

 

 

 

23,191

 

 

 

23,979

 

Litigation settlement expense, net

 

 

11,975

 

 

 

 

 

 

11,975

 

 

 

 

Restructuring charges

 

 

 

 

 

231

 

 

 

 

 

 

6,346

 

Total operating costs & expenses

 

 

40,034

 

 

 

29,099

 

 

 

94,889

 

 

 

93,876

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest & Other Income (Expense)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

13

 

 

 

54

 

 

 

63

 

 

 

247

 

Interest expense

 

 

(1,516

)

 

 

(1,609

)

 

 

(4,624

)

 

 

(4,907

)

Other

 

 

925

 

 

 

(1,067

)

 

 

(391

)

 

 

(1,275

)

Total interest & other income (expense), net

 

 

(578

)

 

 

(2,622

)

 

 

(4,952

)

 

 

(5,935

)

Net loss

 

 

(32,664

)

 

 

(12,479

)

 

 

(78,777

)

 

 

(61,210

)

Less net loss attributable to noncontrolling interest in consolidated variable interest entity

 

 

311

 

 

 

122

 

 

 

1,054

 

 

 

122

 

Net loss attributable to stockholders of Arena

 

$

(32,353

)

 

$

(12,357

)

 

$

(77,723

)

 

$

(61,088

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss attributable to stockholders of Arena per share: 1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.86

)

 

$

(0.51

)

 

$

(2.24

)

 

$

(2.51

)

Diluted

 

$

(0.86

)

 

$

(0.51

)

 

$

(2.24

)

 

$

(2.51

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares used in calculating net loss attributable to stockholders of Arena per share: 1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

37,776

 

 

 

24,325

 

 

 

34,692

 

 

 

24,307

 

Diluted

 

 

37,776

 

 

 

24,325

 

 

 

34,692

 

 

 

24,307

 

 

 

 

1 Comparative period data adjusted to give effect to Arena’s June 2017 1-for-10 reverse stock split.

 

 



Arena Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheet Data

(In thousands)

(unaudited)

 

 

 

September 30, 2017

 

 

December 31, 2016

 

 

 

 

 

 

 

1

 

Assets

  

  

 

  

  

  

 

  

Cash & cash equivalents

 

$

278,738

 

 

$

90,712

 

Accounts receivable

 

 

2,373

 

 

 

20,162

 

Insurance recovery receivable

 

 

12,025

 

 

 

 

Inventory

 

 

6,848

 

 

 

6,708

 

Prepaid expenses & other current assets

 

 

3,717

 

 

 

2,307

 

Land, property & equipment, net

 

 

39,425

 

 

 

43,828

 

Intangibles & other non-current assets

 

 

4,695

 

 

 

5,293

 

Total assets

 

$

347,821

 

 

$

169,010

 

 

 

 

 

 

 

 

 

 

Liabilities & Stockholders’ Equity

 

 

 

 

 

 

 

 

Accounts payable & accrued liabilities

 

$

12,787

 

 

$

25,073

 

Accrued litigation settlement

 

 

24,000

 

 

 

 

Total deferred revenues

 

 

29,258

 

 

 

37,455

 

Total lease financing obligations & other long-term liabilities

 

 

63,655

 

 

 

66,087

 

Total stockholders’ equity

 

 

218,121

 

 

 

40,395

 

Total liabilities & stockholders’ equity

 

$

347,821

 

 

$

169,010

 

 

 

 

1 The Condensed Consolidated Balance Sheet Data have been derived from the audited financial statements as of that date.

 

 

###