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8-K - 8-K - ARENA PHARMACEUTICALS INCarna-8k_20200226.htm

Exhibit 99.1

 

 

 

 

 

Arena Announces Management and Program Updates and

Reports Fourth Quarter and Full-Year 2019 Financial Results

 

 

Appoints Kevin R. Lind as President and Chief Executive Officer of Arena Neuroscience, Inc.

 

Appoints Laurie D. Stelzer as Executive Vice President and Chief Financial Officer of Arena

 

Expects to deliver up to eight major data readouts between 2020-21 and multiple INDs

 

Progressing first- or best-in-class drug candidates with liquidity position of $1.1bn as of year-end 2019

 

SAN DIEGO, Calif., February 26, 2020 - Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today provided a corporate update and reported financial results for the fourth quarter and full-year ended December 31, 2019.

 

“As we continue to execute on near and mid-term operational objectives, including delivering up to eight major data readouts between 2020 and 2021, we must also make the bold, strategic moves necessary to unlock the critical value that we believe our pipeline holds,” said Amit D. Munshi, President and CEO of Arena. “As a result, I am excited to announce the appointment of Kevin Lind, as President and Chief Executive Officer of our subsidiary, Arena Neuroscience, Inc., and the appointment of Laurie Stelzer as Executive Vice President and Chief Financial Officer of Arena.”

 

“I have been tremendously privileged to have joined the company three years ago with the charter to reset Arena and deliver long-term shareholder value,” said Mr. Lind “I am excited to continue that mission by further leveraging the significant potential value of Arena’s world-class GPCR discovery research in the area of neuroscience. We believe Arena Neuroscience has an opportunity to expand treatment options in a therapeutic area where there is an urgent unmet need for patients.”

 

Laurie Stelzer joins Arena from Halozyme Therapeutics, where she has spent the last five years as the Chief Financial Officer, leading the Finance, Information Technology, Business Development, Project Management and Site Operations organizations. Prior to joining Halozyme, Laurie held senior management roles at Shire Plc (acquired by Takeda), including Senior Vice President of Finance, Division CFO for the Regenerative Medicine Division, and Head of Investor Relations. Previously she held positions of increasing responsibility during her fifteen-year career at Amgen, Inc., spanning the areas of Finance, Treasury, Global Accounting and International/Emerging Markets. Laurie received her B.S. in Accounting from Arizona State University, and her M.B.A. from the Anderson School at the University of California, Los Angeles. She currently serves on the board of directors for Surface Oncology.

 

“Laurie is an accomplished executive with significant financial expertise across both emerging and established biotechnology companies and will be an exceptional addition to our management team,” said Mr. Munshi. “Having previously worked with Laurie at Amgen, I am confident in her experience and leadership as we continue to scale a sustainable, vibrant, company while being mindful stewards of our resources.”

 


Program Updates:

 

Etrasimod ELEVATE UC 52 Phase 3 trial in ulcerative colitis (UC) ongoing; ELEVATE UC 12 Phase 3 trial expected to initiate at a later date

 

Etrasimod CULTIVATE Phase 2b dose-ranging trial in Crohn’s disease (CD) initiated and ongoing

 

Etrasimod eosinophilic esophagitis (EoE) Phase 2b and alopecia areata (AA) Phase 2 planning ongoing, initiation expected this year

 

Etrasimod atopic dermatitis (AD) ADVISE Phase 2b trial ongoing; data expected H2 2020

 

Olorinab CAPTIVATE Phase 2b trial in abdominal pain associated with irritable bowel syndrome (IBS-C, IBS-D) ongoing; data expected H2 2020

 

APD418 in acute heart failure (AHF) Phase 1 trial ongoing; Fast Track designation granted

 

Financial Update

 

Fourth Quarter 2019 Financial Results

 

Revenues totaled $3.0 million, primarily consisting of $5.0 million of development milestone revenue from Everest offset by a reduction of estimated future royalties from BELVIQ sales

 

Research and development expenses totaled $74.6 million, including $7.0 million related to non-cash share-based compensation

 

General and administrative expenses totaled $22.2 million, including $6.3 million related to non-cash share-based compensation

 

Net loss was $88.3 million or $1.76 per share

 

Full-Year 2019 Financial Results

 

Revenues totaled $806.4 million, primarily consisting of $800.0 million of revenue from the United Therapeutics upfront payment

 

Research and development expenses totaled $231.5 million, including $27.4 million related to non-cash share-based compensation

 

General and administrative expenses totaled $77.6 million, including $25.7 million related to non-cash share-based compensation

 

Income tax provision was $110.3 million as a result of utilizing the deferred tax assets that were recorded in the fourth quarter of 2018

 

Net income was $397.6 million, or $7.99 per share

 

At December 31, 2019, Arena’s cash, cash equivalents and investments balance was approximately $1.1 billion and approximately 50.2 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, February 26, 2020, at 4:30 PM ET to discuss the financial results and provide a corporate update.

 

When: Wednesday, February 26, 2020, at 4:30 PM ET

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

Conference ID: 8286947

 

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 uniquely positioned to develop best-in-disease medicines with optimized efficacy and safety for patients globally. Our drive to deliver a robust pipeline of novel, transformational medicines is grounded in two decades of world class G-protein-coupled receptor (GPCR) discovery research.

 

It is the breadth and depth of our portfolio, prioritization of drug development to meet unmet patient needs, strong financial health and growing, bold-thinking world-class team that gives Arena the ingredients and passion to build a sustainable, vibrant next generation pharmaceutical company.

 

Etrasimod, olorinab and APD418 are investigational compounds that are not approved for any use in any country.

 

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 “expects,” “objectives,” “believe,” “excited to,” “potential,” “will,” “confident in,” “planning,” “estimated,” and “uniquely positioned to” and include, without limitation, statements about the following: Arena’s planned conference call and webcast with the investment community; design, initiation, enrollment, data and results, and timing relating to ongoing and intended programs and studies, including the timing of planned IND filings, initiation of planned clinical trials, and timing of data readouts; the potential of Arena’s drug candidates, including to be first- or best-in-class, world-class, or best-in disease, have optimized efficacy and safety, have critical value, and satisfy an unmet need; the potential of Arena Neuroscience; and Arena’s position, drive, portfolio, prioritization, financial position, team, and building of the company. 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; Fast Track designation may not result in an expedited regulatory review process; 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 Arena’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, which was filed with the SEC on November 8, 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

 

Arena Media Contact:

IR@arenapharm.com

858-453-7200

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(Tables Follow)

 


Arena Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations

(In thousands, except per share amounts)

 

 

 

 

Three months ended

 

 

Year ended

 

 

 

December 31,

 

 

December 31,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

 

(unaudited)

 

 

 

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

United Therapeutics revenue

 

$

 

 

$

 

 

$

800,000

 

 

$

 

Collaboration and other revenue

 

 

6,580

 

 

 

  6,878

 

 

 

7,284

 

 

 

11,402

 

Royalty revenue

 

 

(3,578

 

 

1,770

 

 

 

(853

 

 

6,568

 

Total revenues

 

 

3,002

 

 

 

8,648

 

 

 

806,431

 

 

 

17,970

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating Costs & Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research & development

 

 

74,632

 

 

 

37,890

 

 

 

231,496

 

 

 

115,029

 

General & administrative

 

 

22,243

 

 

 

12,935

 

 

 

77,616

 

 

 

45,257

 

Transaction costs

 

 

 

 

 

2,467

 

 

 

14,573

 

 

 

2,467

 

Total operating costs & expenses

 

 

96,875

 

 

 

53,292

 

 

 

323,685

 

 

 

162,753

 

Income (loss) from operations

 

 

(93,873

)

 

 

(44,644

)

 

 

482,746

 

 

 

(144,783

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total interest & other income (expense), net

 

 

5,562

 

 

 

3,090

 

 

 

25,142

 

 

 

5,949

 

Income (loss) from continuing operations before income taxes

 

 

(88,311

)

 

 

(41,554

)

 

 

507,888

 

 

 

(138,834

)

Income tax (provision) benefit

 

 

 

 

 

110,265

 

 

 

(110,333

)

 

 

110,265

 

Income (loss) from continuing operations

 

 

(88,311

)

 

 

68,711

 

 

 

397,555

 

 

 

(28,569

)

Loss from discontinued operations

 

 

 

 

 

 

 

 

 

 

 

(830

)

Net income (loss)

 

$

(88,311

)

 

$

68,711

 

 

$

397,555

 

 

$

(29,399

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share, basic:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Continuing operations

 

$

(1.76

)

 

$

1.39

 

 

$

7.99

 

 

$

(0.61

)

Discontinued operations

 

 

 

 

 

 

 

 

 

 

 

(0.02

)

 

 

$

(1.76

)

 

$

1.39

 

 

$

7.99

 

 

$

(0.63

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share, diluted:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Continuing operations

 

$

(1.76

)

 

$

1.35

 

 

$

7.69

 

 

$

(0.61

)

Discontinued operations

 

 

 

 

 

 

 

 

 

 

 

(0.02

)

 

 

$

(1.76

)

 

$

1.35

 

 

$

7.69

 

 

$

(0.63

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

50,113

 

 

 

49,409

 

 

 

49,779

 

 

 

47,041

 

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

 

 

50,113

 

 

 

50,826

 

 

 

51,698

 

 

 

47,041

 

 


Arena Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheet Data

(In thousands)

(Unaudited)

 

 

 

 

December 31, 2019

 

 

December 31, 2018

 

 

 

 

1

 

 

 

1

 

Assets

 

 

 

 

 

 

 

 

Cash & cash equivalents

 

$

243,274

 

 

$

161,037

 

Accounts receivable

 

 

1,654

 

 

 

5,086

 

Deferred tax assets

 

 

 

 

 

110,333

 

Prepaid expenses & other current assets

 

 

18,715

 

 

 

10,008

 

Total available-for-sale investments

 

 

867,229

 

 

 

367,006

 

Land, property & equipment, net

 

 

25,128

 

 

 

23,114

 

Other non-current assets

 

 

18,123

 

 

 

10,319

 

Total assets

 

$

1,174,123

 

 

$

686,903

 

 

 

 

 

 

 

 

 

 

Liabilities & Stockholders’ Equity

 

 

 

 

 

 

 

 

Accounts payable & accrued liabilities

 

$

41,153  

 

 

$

26,635

 

Total lease financing obligations & other long-term liabilities

 

 

61,505

 

 

 

54,010

 

Total stockholders’ equity

 

 

1,071,465

 

 

 

606,258

 

Total liabilities & stockholders’ equity

 

$

1,174,123

 

 

$

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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