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8-K - 8-K - ARENA PHARMACEUTICALS INCarna-8k_20201109.htm

 

Exhibit 99.1

 

 

 

 

Arena Reports Third Quarter Financial Results with Strong Cash Position, Advancing Etrasimod Into a Phase 3 Registrational Program in Atopic Dermatitis 

 

- Delivered compelling topline results from ADVISE Ph 2b trial evaluating etrasimod in atopic dermatitis; advancing into a Ph 3 registrational program 

- Initiated etrasimod trials: ELEVATE UC 12 Ph 3, GLADIATOR UC and alopecia areata Ph 2 

- Completed enrollment of CAPTIVATE Ph 2b trial evaluating olorinab in irritable bowel syndrome (IBS) pain, topline data expected Q1 2020 

- Completed first-in-human Ph 1 trial for APD418 

- Completed launch of Longboard Pharmaceuticals (formerly Arena Neuroscience)  

- Cash, cash equivalents and marketable securities of ~$1.2bn as of September 30, 2020 

- Arena to host conference call and webcast today at 4:30 PM ET to discuss ADVISE results and corporate updates  

 

SAN DIEGO, Calif., November 9, 2020 - Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today provided a corporate update and reported financial results for the third quarter ended September 30, 2020. 

 

"Over the quarter we made significant progress across our pipeline – most importantly with the results from the ADVISE trial giving us confidence to move expeditiously into a registrational program. Additionally, we initiated the ELEVATE UC 12, GLADIATOR UC and alopecia areata trials. We completed enrollment of the CAPTIVATE Phase 2b trial for olorinab, keeping us on track for expected topline data in Q1. In addition, we have completed the Phase 1 trial of APD418 and have plans to initiate our Phase 2 program in 2021. We also successfully spun-off our neurology franchise with the inception of Longboard Pharmaceuticals, to help unlock the value of those assets," said Amit D. Munshi, President and CEO of Arena. "We are optimistic about the next 12-18 months as we continue our efforts to build long-term value for all of our stakeholders and execute on key catalysts."  

 

Program Updates 

 

Etrasimod atopic dermatitis (AD) ADVISE Phase 2b trial delivered topline results; moving forward into a Phase 3 registrational program

 

Etrasimod ELEVATE UC 52 Phase 3 trial in ulcerative colitis (UC) ongoing and on track to complete enrollment by year-end 2020, with the 52-week treatment period ending by year-end 2021 and data expected shortly thereafter; ELEVATE UC 12 Phase 3 trial was initiated, continues to make strong progress with data expected in the same timeframe as UC 52; we continue to monitor the impact of the COVID-19 resurgence on study enrollment for both UC 52 and UC 12

 

Etrasimod GLADIATOR UC Phase 2 planning; initiation expected in Q1 2021 dependent on COVID-19 impact

 

Etrasimod CULTIVATE Phase 2/3 trial in Crohn's disease (CD) ongoing; confirming topline dose-ranging data in 2021; continue to suspend overall program guidance based on COVID-19 impact

 

Etrasimod eosinophilic esophagitis (EoE) Phase 2b VOYAGE trial with initiation expected in 2020 but dependent on COVID-19 impact

 

Etrasimod alopecia areata (AA) Phase 2 initiated; topline data expected H2 2021

 


 

 

Olorinab CAPTIVATE Phase 2b trial in abdominal pain associated with irritable bowel syndrome (IBS-C, IBS-D) enrollment completed; topline data expected Q1 2021

 

APD418 in acute heart failure (AHF) with Fast Track designation; completed the first-in-human Phase 1 trial; APD418 was generally well tolerated; Phase 2 planning ongoing

 

Business Update 

 

In October 2020, Arena announced the launch and the completion of a $56 million financing of Longboard (formerly Arena Neuroscience), an independent company focused on advancing  investigational therapies for rare neurological diseases. Arena shareholders will continue to participate in the value of these assets via Arena's equity position in the new company and potential future royalty streams.

 

Financial Update 

Third Quarter 2020 Financial Results  

 

Revenues for the third quarter were $20,000 compared to $1.4 million in the third quarter of 2019

 

Research and development (R&D) expenses for the third quarter totaled $79.8 million compared to $60.3 million in the same period 2019. This increase was primarily driven by our advancing clinical studies, including the etrasimod Phase 3 program, as well as an increase in personnel expenses as we staff to support our clinical programs. The R&D non-cash, share-based compensation was $6.6 million in the third quarter as compared to $6.7 million in the same period 2019

 

Selling, general and administrative (SG&A) expenses for the third quarter totaled $19.0 million, compared to $20.4 million in the third quarter of 2019. This decrease was primarily driven by a decrease in legal, accounting and other professional fees partially offset by an increase in personnel expenses. The SG&A non-cash, share-based compensation was $5.8 million in the third quarter as compared to $6.6 million in the same period 2019

 

Net loss for the third quarter was $97.4 million compared to net loss of $72.9 million for the same period in 2019

 

Basic and diluted net loss per share for the third quarter was $1.69 compared to basic and diluted net loss per share of $1.46 for the same period in 2019

 

Cash, cash equivalents and marketable securities were $1.2 billion at September 30, 2020, as compared to $1.3 billion at June 30, 2020

 

Financial Outlook for 2020 

Arena’s 2020 financial guidance range: 

 

Cash used in operating activities for the full-year 2020 is expected to be $345 to $355 million, down compared to our previous guidance of $400 to $430 million. Arena continues to achieve key milestones while 2020 full-year operating expenses decrease due to clinical trial efficiency and continued focus on optimizing spend

 

Conference Call & Webcast Information 

Arena will host a conference call and live webcast the investment community today, Monday, November 9, 2020, at 4:30 PM ET, to discuss the financial results and corporate update. 

 

When: Monday, November 9, 2020, at 4:30 PM ET 

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

Conference ID: 6166976 

 


 

Please join the conference call at least 20 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 event 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 team with a singular purpose – deliver our important medicines to patients.  

 

In a rapidly changing global market, we work with a sense of urgency every day to understand the needs of all our stakeholders, identify bold, sometimes disruptive, ideas to get our medicines to patients, and relentlessly execute until it’s done.  

 

ARENA - Care More. Act Differently. 

 

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 “expected,” “will,” “long-term,” “outlook,” and “guidance” and include, without limitation, statements about the following: Arena’s clinical programs, including plans to advance etrasimod into a registrational program in atopic dermatitis, expectations regarding enrollment of study participants and the timing of data readouts for ongoing and anticipated trials, and expectations for the commencement of additional trials; the statements under “Program Updates” above; and Arena’s financial outlook and guidance, including expectations regarding cash to be used in operating activities and the rate of change thereof. 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: topline data may not accurately reflect the complete results of a particular study or trial; 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; 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; the duration and severity of the coronavirus disease (COVID-19) pandemic, including but not limited to the impact on Arena’s clinical operations, the operations of Arena’s suppliers, partners, collaborators, licensees, and capital markets, which in each case remains uncertain; risks related to developing and commercializing drugs; Arena will need additional funds to advance all of its programs; the impact of competition; risks related to unexpected or unfavorable new data; the risk that 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; satisfactory resolution of litigation or other disagreements with others; and risks related to the enforcement of 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, 2019, which was filed with the SEC on February 27, 2020, and Arena’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, which was filed with the SEC on August 5, 2020. 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 Contacts:  

Patrick Malloy 

Arena Pharmaceuticals, Inc.  

Vice President, Investor Relations & Corporate Communications 

pmalloy@arenapharm.com 

847.987.4878 

 

Megan E. Knight 
Arena Pharmaceuticals, Inc. 
Director, Investor Relations  
mknight@arenapharm.com 

858.210.3635 

 

 

(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,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

 

 

(unaudited)

 

 

(unaudited)

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

United Therapeutics revenue

 

$

 

 

$

 

 

$

 

 

$

800,000

 

Royalty revenue

 

 

 

 

 

811

 

 

 

262

 

 

 

2,725

 

Collaboration and other revenue

 

 

20

 

 

 

539

 

 

 

20

 

 

 

704

 

Total revenues

 

 

20

 

 

 

1,350

 

 

 

282

 

 

 

803,429

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating Costs & Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research & development

 

 

79,820

 

 

 

60,257

 

 

 

223,299

 

 

 

156,864

 

Selling, general & administrative

 

 

19,002

 

 

 

20,428

 

 

 

68,321

 

 

 

55,373

 

Transaction costs

 

 

 

 

 

 

 

 

 

 

 

14,573

 

Total operating costs & expenses

 

 

98,822

 

 

 

80,685

 

 

 

291,620

 

 

 

226,810

 

Income (loss) from operations

 

 

(98,802

)

 

 

(79,335

)

 

 

(291,338

)

 

 

576,619

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total interest & other income (expense), net

 

 

1,364

 

 

 

6,470

 

 

 

8,765

 

 

 

19,580

 

Income (loss) before income taxes

 

 

(97,438

)

 

 

(72,865

)

 

 

(282,573

)

 

 

596,199

 

Income tax provision

 

 

 

 

 

 

 

 

 

 

 

(110,333

)

Net income (loss)

 

$

(97,438

)

 

$

(72,865

)

 

$

(282,573

)

 

$

485,866

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share, basic:

 

$

(1.69

)

 

$

(1.46

)

 

$

(5.27

)

 

$

9.78

 

Net income (loss) per share, diluted:

 

$

(1.69

)

 

$

(1.46

)

 

$

(5.27

)

 

$

9.39

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

57,779

 

 

 

49,864

 

 

 

53,608

 

 

 

49,667

 

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

 

 

57,779

 

 

 

49,864

 

 

 

53,608

 

 

 

51,763

 

 

 

 

 


 

Arena Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheet Data

(In thousands)

(Unaudited)

 

 

 

September 30, 2020

 

 

December 31, 2019

 

 

 

 

 

 

 

1

 

Assets

 

 

 

 

 

 

 

 

Cash & cash equivalents

 

$

460,145

 

 

$

243,274

 

Prepaid expenses & other current assets

 

 

34,383

 

 

 

20,369

 

Total available-for-sale investments

 

 

741,005

 

 

 

867,229

 

Land, property & equipment, net

 

 

22,913

 

 

 

25,128

 

Other non-current assets

 

 

17,097

 

 

 

18,123

 

Total assets

 

$

1,275,543

 

 

$

1,174,123

 

 

 

 

 

 

 

 

 

 

Liabilities & Stockholders' Equity

 

 

 

 

 

 

 

 

Accounts payable & accrued liabilities

 

$

47,647

 

 

$

41,153

 

Total lease financing obligations & other long-term liabilities

 

 

57,969

 

 

 

61,505

 

Total stockholders' equity

 

 

1,169,927

 

 

 

1,071,465

 

Total liabilities & stockholders' equity

 

$

1,275,543

 

 

$

1,174,123

 

 

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