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Aimmune Therapeutics Announces Third Quarter 2019 Financial Results and Provides Operational Highlights

November 6, 2019

BRISBANE, Calif.--(BUSINESS WIRE)--Nov 6, 2019--

Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced financial results for the quarter and nine months ended September 30, 2019 and provided operational highlights.

“This is a transformative time for the company as we prepare to launch PALFORZIA TM, our first drug candidate and potentially the first FDA-approved treatment for any food allergy. We were encouraged by the positive vote from the FDA APAC to support the use of PALFORZIA as a treatment for peanut allergy in children and teens, and we look forward to the FDA’s completed review of our BLA in January,” said Jayson Dallas, M.D., President and CEO of Aimmune Therapeutics. “We have continued to make important progress in preparation for PALFORZIA’s commercial launch, if approved, in the first quarter of 2020 - we have completed hiring for our commercial field leadership team, have had further conversations with payors, and have conducted additional physician and patient research to improve our understanding of the market. Finally, we have been working with the FDA to finalize the REMS program which will support the safe and appropriate use of PALFORZIA.”

Third Quarter 2019 Clinical and Operational Highlights

Upcoming Milestones

January 2020

 

 

Expected FDA review action date for PALFORZIA BLA

Q1 2020

 

 

Potential U.S. commercial launch of PALFORZIA, if approved

H2 2020

 

 

Expected completion of enrollment of AR201 phase 2 trial

H2 2020

 

 

Expected EMA action date for MAA of PALFORZIA for peanut allergy in children and adolescents ages 4 to 17 years

H2 2020

 

 

Potential EU commercial launch of PALFORZIA, if approved

Third Quarter 2019 Financial Results

For the quarter and nine months ended September 30, 2019, net loss was $64.5 million and $181.6 million, respectively, compared to net loss of $51.7 million and $153.8 million, respectively, for the comparable periods in 2018. On a per share basis, net loss for the quarter and nine months ended September 30, 2019, was $1.03 and $2.91, respectively, compared to net loss per share of $0.89 and $2.72, respectively, for the comparable periods in 2018. The weighted average shares outstanding for the quarter and nine months ended September 30, 2019, were 62.6 million and 62.3 million shares, respectively, compared to 58.3 million and 56.6 million shares, respectively, for the comparable periods in 2018.

Research and development expenses for the quarter and nine months ended September 30, 2019 were $30.6 million and $93.9 million, respectively, compared to $31.7 million and $100.4 million, respectively, for the comparable periods in 2018. The decrease was primarily due to lower costs related to the completion of certain PALFORZIA clinical trials, partially offset by higher costs related to regulatory activities and increased contract manufacturing costs to support potential commercialization of PALFORZIA as well as costs related to the phase 2 clinical trial of AR201 for egg allergy.

General and administrative expenses for the quarter and nine months ended September 30, 2019 were $34.0 million and $89.0 million, respectively, compared to $21.3 million and $56.5 million, respectively, for the comparable periods in 2018. The increase was primarily due to additional employee-related costs and external professional services as Aimmune continued to build its infrastructure to support the development and potential commercialization of PALFORZIA.

Cash, cash equivalents, and investments totaled $200.5 million on September 30, 2019, compared to $303.9 million on December 31, 2018. The decrease primarily reflects net cash used in operating activities, partially offset by cash provided by financing activities, including net borrowings from our debt issuance in January 2019 of $36.1 million.

Conference Call

In connection with this announcement, Aimmune Therapeutics will host a conference call and webcast today at 4:30 p.m. ET. To access the live call by phone, dial (877) 497-1438 (domestic) or (262) 558-6296 (international) and enter the passcode 7842939. To access a live or recorded webcast of the call, please visit the Investor Relations section of the Aimmune Therapeutics website at www.aimmune.com. The recorded webcast will be available for approximately 30 days following the call.

About PALFORZIA™

PALFORZIA™ is an investigational, peanut-derived, biologic product candidate for use in oral immunotherapy in patients with peanut allergy. The drug candidate, which is manufactured in accordance with current Good Manufacturing Practices (cGMP), delivers a daily dose of peanut protein with a consistent protein profile, analyzed to ensure reliable major allergen content. The amount of active ingredient in each PALFORZIA capsule is controlled to ensure minimal variability of allergen content across doses of a given strength. PALFORZIA is administered as an oral powder in graduated doses in pull-apart capsules or foil-laminate sachets. The contents are mixed thoroughly with a few spoonfuls of age-appropriate, unheated food of the patient’s choice.

About AR201

AR201 is an investigational biologic product candidate in clinical development for use in oral immunotherapy in patients with egg allergy. Academic studies of the oral immunotherapy approach for egg allergy treatment have shown efficacy, and Aimmune is studying this more broadly with AR201 in order to enable widespread availability of a potential treatment. Aimmune has an exclusive supply agreement for egg protein with Michael Foods, Inc., the largest U.S. processor of value-added eggs. The agreement includes all of the company’s egg products, worldwide, and gives Aimmune exclusive access to the clinical and commercial use of Michael Foods egg products for any egg allergy treatment, prevention or cure for a period of up to 15 years beyond the potential approval of AR201.

About Aimmune Therapeutics

Aimmune Therapeutics, Inc., is a biopharmaceutical company developing oral treatments for potentially life-threatening food allergies. The Company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to provide meaningful levels of protection against allergic reactions resulting from exposure to food allergens by desensitizing patients with defined, precise amounts of key allergens. Aimmune’s first, investigational, complex biologic product candidate, PALFORZIA™ (AR101), is being developed as a treatment to reduce the frequency and severity of adverse events following exposure to peanut. The BLA for PALFORZIA is under review by the FDA, which granted PALFORZIA Breakthrough Therapy Designation in 2015 for the desensitization of peanut-allergic patients 4 to 17 years of age. The European Medicines Agency (EMA) is reviewing Aimmune’s Marketing Authorization Application (MAA) for PALFORZIA, which Aimmune submitted in June 2019. Aimmune initiated a randomized phase 2 clinical trial of its second investigational, complex biologic product, AR201, for the treatment of egg allergy in August 2019. For more information, please see www.aimmune.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Aimmune’s expectations regarding the potential benefits of PALFORZIA; Aimmune’s expectations regarding the potential commercial launch of PALFORZIA, including the review period of the BLA and MAA for PALFORZIA and launch timelines in the United States and Europe; Aimmune’s expectations on the timing of the completion of enrollment for its phase 2 clinical trial for AR201: Aimmune’s expectations regarding the adequacy and sufficiency of its commercial supply of PALFORZIA; Aimmune’s expectations regarding the sufficiency of its cash resources; and Aimmune’s expectations regarding potential applications of the CODIT™ approach to treating life-threatening food allergies. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the expectation that Aimmune will need additional funds to finance its operations; Aimmune’s or any of its collaborative partners’ ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Aimmune’s or any of its collaborative partners’ clinical trials will not be successful; Aimmune’s dependence on the success of PALFORZIA; Aimmune’s reliance on third parties for the manufacture of Aimmune’s product candidates; possible regulatory developments in the United States and foreign countries; and Aimmune’s ability to attract and retain senior management personnel. These and other risks and uncertainties are described more fully in Aimmune’s most recent filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2019. All forward-looking statements contained in this press release speak only as of the date on which they were made. Aimmune undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

This press release concerns PALFORZIA and AR201, product candidates that are under clinical investigation. Neither PALFORZIA nor AR201 has been approved for marketing by the FDA or the EMA. PALFORZIA and AR201 are currently limited to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are being investigated.

PALFORZIA™ is a trademark of Aimmune Therapeutics, Inc.

 

AIMMUNE THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

 

 

 

 

 

 

 

 

 

September 30,
2019
(Unaudited)

 

 

December 31,
2018 (1)

Assets

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

76,844

 

 

$

107,511

Short-term investments

 

 

118,626

 

 

 

196,421

Prepaid expenses and other current assets

 

 

6,766

 

 

 

8,687

Total current assets

 

 

202,236

 

 

 

312,619

 

Long-term investments

 

 

5,038

 

 

 

Property and equipment, net

 

 

28,713

 

 

 

26,328

Operating lease right-of-use assets

 

 

11,904

 

 

 

Prepaid expenses and other assets

 

 

507

 

 

 

608

Total assets

 

$

248,398

 

 

$

339,555

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

Current liabilities

 

$

43,605

 

 

$

38,012

Long term debt, net of discount

 

 

39,782

 

 

 

Operating lease liabilities, non-current

 

 

11,153

 

 

 

Other liabilities

 

 

1,166

 

 

 

2,596

Stockholders’ equity

 

 

152,692

 

 

 

298,947

Total liabilities and stockholders’ equity

 

$

248,398

 

 

$

339,555

 

(1) Derived from the audited financial statements, included in the Company's Annual Report on Form 10-K for the year ended December 31, 2018.

 

AIMMUNE THERAPEUTICS, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

(In thousands, except per share amounts)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Quarter Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Operating Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development (1)

 

$

30,558

 

 

$

31,691

 

 

$

93,862

 

 

$

100,391

 

General and administrative (1)

 

 

34,044

 

 

 

21,285

 

 

 

88,956

 

 

 

56,517

 

Total operating expenses

 

 

64,602

 

 

 

52,976

 

 

 

182,818

 

 

 

156,908

 

Loss from operations

 

 

(64,602

)

 

 

(52,976

)

 

 

(182,818

)

 

 

(156,908

)

Interest income, net

 

 

43

 

 

 

1,303

 

 

 

1,192

 

 

 

3,233

 

Loss before provision for income taxes

 

 

(64,559

)

 

 

(51,673

)

 

 

(181,626

)

 

 

(153,675

)

(Benefit) Provision for income taxes

 

 

(104

)

 

 

29

 

 

 

(27

)

 

 

79

 

Net loss

 

$

(64,455

)

 

$

(51,702

)

 

$

(181,599

)

 

$

(153,754

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per common share, basic and diluted

 

$

(1.03

)

 

$

(0.89

)

 

$

(2.91

)

 

$

(2.72

)

Shares used in computing net loss per common share, basic and diluted

 

 

62,615

 

 

 

58,274

 

 

 

62,325

 

 

 

56,602

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1) Includes stock-based compensation expenses of:

 

 

 

 

 

 

 

 

 

 

 

Quarter Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Research and development

 

$

2,752

 

 

$

2,406

 

 

$

8,452

 

 

$

7,376

 

General and administrative

 

 

5,329

 

 

 

5,976

 

 

 

16,134

 

 

 

17,287

 

Total stock-based compensation expenses

 

$

8,081

 

 

$

8,382

 

 

$

24,586

 

 

$

24,663

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

View source version on businesswire.com:https://www.businesswire.com/news/home/20191106005929/en/

CONTACT: Investors:

DeDe Sheel

(917) 834-1494 or

dsheel@aimmune.com Media:

Jerica Pitts

(312) 858-3469

jpitts@w2ogroup.com

KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA

INDUSTRY KEYWORD: BIOTECHNOLOGY FDA HEALTH PHARMACEUTICAL CLINICAL TRIALS

SOURCE: Aimmune Therapeutics, Inc.

Copyright Business Wire 2019.

PUB: 11/06/2019 04:05 PM/DISC: 11/06/2019 04:05 PM

http://www.businesswire.com/news/home/20191106005929/en