Arena Pharmaceuticals, Inc.
ARENA PHARMACEUTICALS INC (Form: 8-K, Received: 08/07/2017 16:04:54)

 

 

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): August 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 August 7, 2017, we issued a press release report i ng our f i n a nc i al resul t s for t he second quar t er ended June 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 August 7, 2017, rep o r t i n g f ina n c ia l res u lt s fo r th e second q ua r te r en d ed June 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: August 7, 2017

Arena Pharmaceuticals, Inc.

 

 

 

 

 

By:

 

/s/ Amit Munshi

 

 

 

Amit Munshi

 

 

 

President and Chief Executive Officer

 

 


 

Exhibit Index

 

Exhibit

Number

 

Description

99.1

 

Press release issued August 7, 2017, reporting financial results for the second quarter ended June 30, 2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exhibit 99.1

 

 

 

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

 

- Achieved Positive Phase 2 Results for Ralinepag in July, Phase 3 Preparations Underway

- Clinical Results from Additional Phase 2 Programs Expected Over the Next Several Quarters

 

SAN DIEGO, August 7, 2017 -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA), a biopharmaceutical company focused on developing novel, small molecule drugs across multiple therapeutic areas, today provided a corporate update and reported financial results for the second quarter ended June 30, 2017.

 

“We are excited about the continued transformation of Arena in the past quarter, punctuated by the significant results achieved in the Phase 2 trial of ralinepag,” said Amit Munshi, President and CEO of Arena. “With preparations underway for an end of Phase 2 meeting with the FDA for ralinepag, as well as multiple clinical data readouts from our other pipeline programs expected over the next several quarters, we are excited about the opportunity to continue driving shareholder value.”

 

Pipeline Update

 

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

 

In May, completed a pharmacokinetic and pharmacodynamic study comparing current twice-daily formulation with a new once-daily formulation in healthy volunteers

 

In July, achieved positive Phase 2 results for ralinepag

 

Currently preparing for end of Phase 2 meeting with the FDA; Phase 3 clinical program preparations underway  

 

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

 

Phase 2 study in ulcerative colitis - data readout expected around year-end 2017 to Q1 2018

 

Exploratory Phase 2 studies currently enrolling patients

 

o

Phase 2 study in dermatological extraintestinal manifestations in patients with inflammatory bowel disease

 

o

Phase 2 study in pyoderma gangrenosum

 

Phase 2 study in primary biliary cholangitis

 

o

Expected to initiate in 2017

 

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 readout expected around year-end 2017 to Q1 2018

 


Corporate Update

 

Appointed Jennifer Jarrett to the Company's Board of Directors

 

Financial Update

Second Quarter 2017 Financial Results

 

Revenues totaled $6.5 million, including $2.1 million in net product sales of BELVIQ, $1.8 million in manufacturing support payments from Eisai, and approximately $1.9 million of revenue associated with upfront payments from Boehringer Ingelheim and Axovant collaborations

 

Research and development expenses totaled $17.9 million

 

General and administrative expenses totaled $7.2 million

 

Net loss was $23.6 million, or $0.77 per share

 

In June 2017, the Company completed a 1-for-10 reverse stock split. All per-share figures in this update, including in the attached tables, have been adjusted to account for the impact of the reverse stock split.

 

At June 30, 2017, cash and cash equivalents totaled $130.8 million, and approximately 31.8 million shares of Arena common stock were outstanding. This does not include the $162.0 million in net proceeds received through July 28, 2017, for issuing and selling approximately 7 million shares of common stock under an equity financing.

 

Conference Call & Webcast Information

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

 

When: August 7, 2017, 4:30 p.m. ET

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

Conference ID: 60106084

 

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 candidate), 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 “will”, “may”, “expect”, “potential” and similar words, and include, without limitation, statements about the significance of clinical data, shareholder value creation, advancement of our pipeline, expected results, anticipated data readouts, planned meetings with the FDA, timing relating to ongoing or intended clinical trials, patient enrollment in ongoing or intended clinical trials, and Arena’s focus, goals, strategy and clinical


programs. For such state ments, 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 stat ements 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 add itional 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 da ta; 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 recommend ations 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 o ther 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 disagre ements 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-looki ng 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)

(unaudited)

 

 

 

Three months ended

 

 

Six months ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

 

(unaudited)

 

 

(unaudited)

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net product sales

 

$

2,059

 

 

$

4,263

 

 

$

4,770

 

 

$

7,781

 

Other Eisai collaborative revenue

 

 

1,781

 

 

 

1,975

 

 

 

3,316

 

 

 

5,201

 

Other collaborative revenue

 

 

1,898

 

 

 

2,249

 

 

 

3,558

 

 

 

4,329

 

Toll manufacturing

 

 

754

 

 

 

1,025

 

 

 

1,472

 

 

 

2,048

 

Total revenues

 

 

6,492

 

 

 

9,512

 

 

 

13,116

 

 

 

19,359

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating Costs & Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product sales

 

 

1,497

 

 

 

851

 

 

 

4,029

 

 

 

3,279

 

Cost of toll manufacturing

 

 

1,074

 

 

 

1,758

 

 

 

1,993

 

 

 

2,946

 

Research & development

 

 

17,922

 

 

 

18,546

 

 

 

33,433

 

 

 

37,048

 

General & administrative

 

 

7,236

 

 

 

8,465

 

 

 

15,400

 

 

 

15,389

 

Restructuring charges

 

 

 

 

 

6,115

 

 

 

 

 

 

6,115

 

Total operating costs & expenses

 

 

27,729

 

 

 

35,735

 

 

 

54,855

 

 

 

64,777

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest & Other Income (Expense)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

16

 

 

 

105

 

 

 

50

 

 

 

193

 

Interest expense

 

 

(1,538

)

 

 

(1,619

)

 

 

(3,108

)

 

 

(3,298

)

Other

 

 

(857

)

 

 

554

 

 

 

(1,316

)

 

 

(208

)

Total interest & other income (expense), net

 

 

(2,379

)

 

 

(960

)

 

 

(4,374

)

 

 

(3,313

)

Net loss

 

 

(23,616

)

 

 

(27,183

)

 

 

(46,113

)

 

 

(48,731

)

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

 

 

299

 

 

 

 

 

 

743

 

 

 

 

Net income (loss) attributable to stockholders of Arena

 

$

(23,317

)

 

$

(27,183

)

 

$

(45,370

)

 

$

(48,731

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net  income (loss) attributable to stockholders of Arena per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.77

)

 

$

(1.12

)

 

$

(1.66

)

 

$

(2.01

)

Diluted

 

$

(0.77

)

 

$

(1.12

)

 

$

(1.66

)

 

$

(2.01

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

30,229

 

 

 

24,308

 

 

 

27,371

 

 

 

24,298

 

Diluted

 

 

30,229

 

 

 

24,308

 

 

 

27,371

 

 

 

24,298

 

 



Arena P harmaceuticals, Inc.

Condensed Consolidated Balance Sheet Data

(In thousands)

(unaudited)

 

 

 

June 30, 2017

 

 

December 31, 2016

 

 

 

 

 

 

 

1

 

Assets

  

  

 

  

  

  

 

  

Cash & cash equivalents

 

$

130,763

 

 

$

90,712

 

Accounts receivable

 

 

2,404

 

 

 

20,162

 

Inventory

 

 

7,058

 

 

 

6,708

 

Prepaid expenses & other current assets

 

 

3,373

 

 

 

2,307

 

Land, property & equipment, net

 

 

40,997

 

 

 

43,828

 

Intangibles & other non-current assets

 

 

4,770

 

 

 

5,293

 

Total assets

 

$

189,365

 

 

$

169,010

 

 

 

 

 

 

 

 

 

 

Liabilities & Stockholders’ Equity

 

 

 

 

 

 

 

 

Accounts payable & accrued liabilities

 

$

9,913

 

 

$

25,073

 

Total deferred revenues

 

 

32,442

 

 

 

37,455

 

Total lease financing obligations & other long-term liabilities

 

 

64,487

 

 

 

66,087

 

Total stockholders’ equity

 

 

82,523

 

 

 

40,395

 

Total liabilities & stockholders’ equity

 

$

189,365

 

 

$

169,010

 

 

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

 

###