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Prothena Reports Fourth Quarter and Full Year 2022 Financial Results, and Provides Financial Guidance and Business Highlights

BusinessWire

 

DUBLIN–(BUSINESS WIRE)–$PRTA #prothena–Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, today reported financial results for the fourth quarter and full year 2022. In addition, the Company provided 2023 financial guidance and business highlights.

“In 2022 we meaningfully advanced our protein dysregulation portfolio as we continue our transition to a fully integrated commercial company. The foundation we established in 2022 has positioned the next 24 months as a transformational period for Prothena, with many significant clinical milestones expected across six different programs in areas of high unmet patient need,” said Gene Kinney, Ph.D., President and Chief Executive Officer Prothena. “For PRX012, we received clearance from the FDA for our IND application and Fast Track designation was granted. We also initiated the Phase 1 SAD and MAD study for PRX012 and completed the Phase 1 SAD and initiated the MAD study for PRX005. Additionally, we presented key data on birtamimab and PRX123 at ASH and AD/PD, respectively. As we grew our organization’s capabilities to prepare for the future, we also added significant strategic depth to our board of directors through the appointment of an established biotech leader, Helen S. Kim, MBA.”

2022 Business Highlights and Upcoming Milestones

Neurodegenerative Diseases Portfolio

Alzheimer’s Disease (AD)

PRX012, a potential best-in-class, next-generation subcutaneous antibody for the treatment of AD, that targets a key epitope at the N-terminus of amyloid beta (Aβ) with high binding potency

PRX005, a potential best-in-class antibody, for the treatment of AD that specifically targets a key epitope within the microtubule binding region (MTBR) of tau, a protein implicated in diseases including AD, frontotemporal dementia (FTD), progressive supranuclear palsy (PSP), chronic traumatic encephalopathy (CTE), and other tauopathies. PRX005 is part of a global neuroscience research and development collaboration with Bristol Myers Squibb

PRX123, a potential first-in-class dual Aβ/tau vaccine, for the treatment and prevention of AD, that is a dual-target vaccine targeting key epitopes within the N-terminus of Aβ and MTBR-tau to promote amyloid clearance and blockade of pathogenic tau

Parkinson’s Disease (PD)

Prasinezumab, a potential first-in-class antibody, for the treatment of PD, that is designed to target key epitopes within the C-terminus of alpha-synuclein and is the focus of a worldwide collaboration with Roche

Rare Peripheral Amyloid Diseases Portfolio

AL Amyloidosis

Birtamimab, a potential best-in-class amyloid depleter antibody, for the treatment of AL amyloidosis, that is designed to directly neutralize soluble toxic aggregates and promote clearance of amyloid that causes organ dysfunction and failure

ATTR Amyloidosis

NNC6019 (formerly PRX004), a potential first-in-class antibody, for the treatment of ATTR cardiomyopathy, that is designed to deplete the pathogenic, non-native forms of the transthyretin (TTR) protein and is being developed by Novo Nordisk as part of their up to $1.2 billion acquisition of Prothena’s ATTR amyloidosis business and pipeline

2022 Organizational and Corporate Highlights

Upcoming Investor Conferences

Members of the senior management team will present and participate in investor meetings at the following upcoming investor conferences:

Fourth Quarter and Full Year of 2022 Financial Results

For the fourth quarter and full year of 2022, Prothena reported a net income of $6.3 million and a net loss of $116.9 million, respectively, as compared to a net loss of $33.2 million and a net income of $67.0 million for the fourth quarter and full year of 2021, respectively. Net income per share on a diluted basis was $0.12 for the fourth quarter of 2022 and net loss per share of for the full year of 2022 was $2.47, as compared to net loss per share of $0.71 and net income per share on a diluted basis of $1.38 for the fourth quarter and full year of 2021, respectively.

Prothena reported total revenue of $49.9 million and $53.9 million for the fourth quarter and full year of 2022, respectively, as compared to total revenue of $1.2 million and $200.6 million for the fourth quarter and full year of 2021, respectively. Total revenue for the fourth quarter and full year of 2022 included a $40.0 million milestone payment from Novo Nordisk and revenue for fourth quarter and full year of 2022 included BMS collaboration revenue of $9.9 million and $13.9 million, respectively. This compares to total revenue of $1.2 million for the fourth quarter of 2021 from BMS collaboration revenue, and total revenue of $200.6 million for the full year of 2021, which included $79.7 million in collaboration revenue from BMS, a $60.0 million clinical milestone payment from Roche and $60.7 million from the sale of intellectual property and related rights to Novo Nordisk.

Research and development (R&D) expenses totaled $36.9 million and $135.6 million for the fourth quarter and full year of 2022, respectively, as compared to $22.1 million and $82.3 million for the fourth quarter and full year of 2021, respectively. The increase in R&D expense for the fourth quarter and full year of 2022 compared to the same periods in the prior year was primarily due to higher manufacturing costs, higher personnel related expenses, higher clinical trial expenses, higher consulting and other R&D expenses. For the full year of 2022, the higher costs were offset in part by lower collaboration expenses with Roche and lower manufacturing expenses related to the NNC6019 (formerly PRX004) program. R&D expenses included non-cash share-based compensation expense of $3.5 million and $14.8 million for the fourth quarter and full year of 2022, respectively, as compared to $2.9 million and $9.5 million for the fourth quarter and full year of 2021, respectively.

General and administrative (G&A) expenses totaled $13.1 million and $49.9 million for the fourth quarter and full year of 2022, respectively, as compared to $12.2 million and $46.3 million for the fourth quarter and full year of 2021, respectively. The increase in G&A expenses for the fourth quarter and full year of 2022 compared to the same periods in the prior year was primarily related to higher personnel related and consulting expenses offset in part by lower legal expenses. G&A expenses included non-cash share-based compensation expense of $3.9 million and $16.5 million for the fourth quarter and full year of 2022, respectively, as compared to $4.0 million and $15.1 million for the fourth quarter and full year of 2021, respectively.

Total non-cash share-based compensation expense was $7.4 million and $31.3 million for the fourth quarter and full year of 2022, respectively, as compared to $6.9 million and $24.7 million for the fourth quarter and full year of 2021, respectively.

As of December 31, 2022, Prothena had $712.6 million in cash, cash equivalents and restricted cash, and no debt.

As of February 17, 2023, Prothena had approximately 52.6 million ordinary shares outstanding.

2023 Financial Guidance

The Company expects the full year 2023 net cash used in operating and investing activities to be $213 to $229 million and expects to end the year with approximately $512 million in cash, cash equivalents and restricted cash (midpoint). The estimated full year 2023 net cash used in operating and investing activities is primarily driven by an estimated net loss of $250 to $275 million, which includes an estimated $46 million of non-cash share-based compensation expense.

Conference Call Details

Prothena management will discuss these results and its 2023 financial guidance during a live audio conference call today, Thursday, February 23, 2023, at 4:30 PM ET. The conference call will be made available on the Company’s website at www.prothena.com under the Investors tab in the Events and Presentations section. Following the live audio webcast, a replay will be available on the Company’s website for at least 90 days.

To access the call via dial-in, please dial +1 (888) 350-3870 (U.S. and Canada toll free) or +1 (646) 960-0308 (international) five minutes prior to the start time and refer to conference ID number 92750. A replay of the call will be available until March 2, 2023, via dial-in at (800) 770-2030 (U.S. toll free) or +00 1 647 362-9199 (international), Conference ID Number 92750.

About Prothena

Prothena Corporation plc is a late-stage clinical biotechnology company with expertise in protein dysregulation and a pipeline of investigational therapeutics with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including AL amyloidosis, ATTR amyloidosis, Alzheimer’s disease, Parkinson’s disease and a number of other neurodegenerative diseases. For more information, please visit the Company’s website at www.prothena.com and follow the Company on Twitter @ProthenaCorp.

Forward-Looking Statements

This press release contains forward-looking statements. These statements relate to, among other things, the sufficiency of our cash position to fund advancement of a broad pipeline; the continued advancement of our discovery, preclinical, and clinical pipeline, and expected milestones in 2023 and beyond; the treatment potential, designs, proposed mechanisms of action, and potential administration of birtamimab, prasinezumab, PRX004, PRX005, PRX012, and PRX123; plans for future clinical studies of birtamimab, prasinezumab, PRX004, PRX005, PRX012, and PRX123 (including the filing of an IND application); the expected timing of reporting data from clinical studies of birtamimab, prasinezumab, PRX004, PRX005, and PRX012; our anticipated net cash burn from operating and investing activities for 2023 and expected cash balance at the end of 2023; and our estimated net loss and non-cash share-based compensation expense for 2023. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to those described in the “Risk Factors” sections of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 3, 2022, discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC, and our Annual Report on Form 10-K to be filed with the SEC for our fiscal year 2022. We undertake no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events, or changes in our expectations.

PROTHENA CORPORATION PLC

CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited – amounts in thousands except per share data)

 

 

Three Months Ended

December 31,

 

Year Ended

December 31,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

Collaboration revenue

 

$

9,923

 

$

1,172

 

$

13,855

 

$

139,833

Revenue from license and intellectual property

 

 

40,000

 

 

—

 

 

40,050

 

 

60,744

Total revenue

 

 

49,923

 

 

1,172

 

 

53,905

 

 

200,577

Operating expenses:

 

 

 

 

 

 

 

 

Research and development

 

 

36,871

 

 

22,058

 

 

135,562

 

 

82,284

General and administrative

 

 

13,124

 

 

12,206

 

 

49,900

 

 

46,318

Total operating expenses

 

 

49,995

 

 

34,264

 

 

185,462

 

 

128,602

Income (loss) from operations

 

 

(72)

 

 

(33,092)

 

 

(131,557)

 

 

71,975

Other income (expense), net

 

 

3,417

 

 

(4)

 

 

5,952

 

 

(54)

Income (loss) before income taxes

 

 

3,345

 

 

(33,096)

 

 

(125,605)

 

 

71,921

Provision for (benefit from) income taxes

 

 

(3,004)

 

 

83

 

 

(8,656)

 

 

4,946

Net income (loss)

 

$

6,349

 

$

(33,179)

 

$

(116,949)

 

$

66,975

Basic net income (loss) per ordinary share

 

$

0.13

 

$

(0.71)

 

$

(2.47)

 

$

1.51

Diluted net income (loss) per ordinary share

 

$

0.12

 

$

(0.71)

 

$

(2.47)

 

$

1.38

Shares used to compute basic net income (loss) per share

 

 

48,960

 

 

46,618

 

 

47,369

 

 

44,228

Shares used to compute diluted net income (loss) per share

 

 

53,979

 

 

46,618

 

 

47,369

 

 

48,464

PROTHENA CORPORATION PLC

CONSOLIDATED BALANCE SHEETS

(unaudited – amounts in thousands)

 

December 31,

 

December 31,

 

 

2022

 

 

2021

Assets

 

 

 

Cash and cash equivalents

$

710,406

 

$

579,094

Prepaid expenses and other current assets

 

8,692

 

 

5,715

Total current assets

 

719,098

 

 

584,809

Property and equipment, net

 

1,731

 

 

2,012

Operating lease right-of-use assets

 

6,277

 

 

12,123

Restricted cash, non-current

 

2,212

 

 

1,352

Other non-current assets

 

28,717

 

 

9,070

Total non-current assets

 

38,937

 

 

24,557

Total assets

$

758,035

 

$

609,366

Liabilities and Shareholders’ Equity

 

 

 

Accrued research and development

 

10,794

 

 

6,351

Deferred revenue, current

 

11,442

 

 

7,657

Lease liability, current

 

6,473

 

 

5,940

Other current liabilities

 

21,438

 

 

13,504

Total current liabilities

 

50,147

 

 

33,452

Deferred revenue, non current

 

85,293

 

 

102,933

Lease liability, non-current

 

—

 

 

6,386

Other non-current liabilities

 

553

 

 

553

Total non-current liabilities

 

85,846

 

 

109,872

Total liabilities

 

135,993

 

 

143,324

Total shareholders’ equity

 

622,042

 

 

466,042

Total liabilities and shareholders’ equity

$

758,035

 

$

609,366

 

Contacts

Media

Michael Bachner, Senior Director, Corporate Communications

609-664-7308, michael.bachner@prothena.com

Investors

IR@prothena.com

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