AEON Biopharma Reports Second Quarter 2024 Financial Results and Provides Corporate Update

Rhea-AI Summary

AEON Biopharma (NYSE: AEON) reported its Q2 2024 financial results and provided a corporate update. The company is progressing plans to develop ABP-450 (prabotulinumtoxinA) injection as a biosimilar to BOTOX®. AEON is scheduled to hold a biosimilar initial advisory meeting with FDA in Q3 2024. The 351(k) regulatory pathway offers potential for a single approval for all of BOTOX's current and future therapeutic indications.

Key highlights include:

• Plans to initiate a single pivotal clinical study in cervical dystonia (CD)
• Submitted a briefing package to FDA with extensive data
• Expects to start a Phase 3 CD study with ~400 patients
• Aims to demonstrate non-inferiority to BOTOX

The biosimilar approach may offer a potential regulatory pathway to bring ABP-450's differentiated economic model to the U.S. market efficiently.

Positive

• Progressing development of ABP-450 as a biosimilar to BOTOX®, potentially addressing multiple therapeutic indications
• Scheduled FDA biosimilar initial advisory meeting in Q3 2024, indicating regulatory progress
• 351(k) pathway offers potential for single approval covering all of BOTOX's current and future therapeutic indications
• Plans to initiate a single pivotal clinical study in cervical dystonia, streamlining the development process

Negative

• Development plans are subject to securing funding, indicating potential financial constraints
• No financial results or metrics provided in the press release

Insights

Biotechnology Analyst

AEON Biopharma's strategic shift towards developing ABP-450 as a biosimilar to BOTOX is a game-changing move. This approach could significantly accelerate market entry and expand indications for ABP-450. The 351(k) pathway offers a streamlined regulatory process, potentially allowing AEON to capture a share of BOTOX's $4+ billion therapeutic market with a single approval.

The planned Phase 3 study in cervical dystonia, aiming to demonstrate non-inferiority to BOTOX, is a critical milestone. If successful, it could pave the way for approval across all of BOTOX's current and future therapeutic indications. This strategy could significantly reduce development costs and time-to-market, potentially positioning AEON as a major player in the botulinum toxin market.

However, investors should note that the success of this strategy hinges on the upcoming FDA meeting and securing necessary funding for the pivotal study. The competitive landscape and BOTOX's established market position remain significant challenges.

Regulatory Affairs Specialist

AEON's decision to pursue the 351(k) biosimilar pathway for ABP-450 is a shrewd regulatory strategy. This approach offers several advantages:

• Potential for a single approval covering multiple indications
• Reduced clinical trial requirements compared to a new drug application
• Faster time-to-market
• Lower development costs

The upcoming FDA biosimilar initial advisory meeting is crucial. A positive outcome could provide AEON with a clear roadmap for their development program. The company's submission of extensive analytical, pharmacological and animal study data demonstrates thorough preparation, which could favorably impress the FDA.

However, the biosimilar pathway also presents challenges, including the need to demonstrate high similarity to BOTOX across multiple quality attributes. The success of this strategy will heavily depend on the outcome of the FDA meeting and the subsequent Phase 3 study.

– Progressing plans to develop ABP-450 (prabotulinumtoxinA) injection as a biosimilar utilizing BOTOX^® (onabotulinumtoxinA) as the reference product –

– Scheduled to hold a biosimilar initial advisory meeting with FDA in 3Q 2024 –

– 351(k) regulatory pathway offers potential to bring ABP-450 to the U.S. market under a single approval for all of BOTOX’s currently approved and future therapeutic indications –

IRVINE, Calif., Aug. 12, 2024 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for the treatment of multiple therapeutic indications, announced financial results for the second quarter ended June 30, 2024, and provided a business update.

“We are excited by the significant opportunity to advance our development of ABP-450 under the planned biosimilar strategy. Once we host and receive the minutes from our FDA meeting, which is being held later this quarter, we expect to have a clear path forward to initiate a single pivotal study directly comparing ABP-450 to BOTOX in the treatment of CD,” commented Marc Forth, AEON’s President and Chief Executive Officer. “The biosimilar approach may offer a potential regulatory pathway for us to bring ABP-450 differentiated economic model to the U.S. market for all of BOTOX’s currently approved and future therapeutic indications under a single approval.”

Recent Clinical and Corporate Highlights

• Development plan for ABP-450 utilizing 351(k) regulatory pathway for biosimilars - announced plans to initiate, subject to securing funding, a single pivotal clinical development study in cervical dystonia (“CD”) for the Company’s lead candidate, ABP-450 (prabotulinumtoxinA), utilizing the 351(k) regulatory pathway for biosimilars with the market leader, BOTOX^® (onabotulinumtoxinA), as the reference product.
  • Submitted a briefing package to the FDA that provided extensive data from analytical, pharmacological, and animal studies that could contribute to a Biologics License Application (“BLA”) filing.
  • Scheduled to hold a biosimilar initial advisory meeting with FDA in 3Q 2024.
  • Expect to initiate a planned Phase 3 CD study in approximately 400 patients to compare ABP-450 to BOTOX with a goal to demonstrate non-inferiority to BOTOX.
  • A successful Phase 3 comparative study in CD could potentially provide the necessary clinical data to support a determination that ABP-450 is highly similar to Botox for all currently approved and future therapeutic indications.
    

About AEON Biopharma

AEON is a clinical stage biopharmaceutical company focused on developing its proprietary botulinum toxin complex, ABP-450 (prabotulinumtoxinA) injection, or ABP-450, for debilitating medical conditions, with an initial focus on the neurosciences market. ABP-450 is the same botulinum toxin complex that is currently approved and marketed for cosmetic indications by Evolus under the name Jeuveau. ABP-450 is manufactured by Daewoong in compliance with current Good Manufacturing Practice, or cGMP, in a facility that has been approved by the U.S. Food and Drug Administration, Health Canada and European Medicines Agency. The product is approved as a biosimilar in Mexico and India. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and certain other international territories. The Company has built a highly experienced management team with specific experience in biopharmaceutical and botulinum toxin development and commercialization. To learn more about AEON, visit www.aeonbiopharma.com.

Forward-Looking Statements

Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or AEON’s future financial or operating performance. For example, statements regarding meetings with the FDA, the timing of a potential Phase 3 comparative study in CD, the translation of clinical trial results into support for a BLA filing, and potential determination that ABP-450 is highly similar to the reference product for currently approved and future therapeutic indications are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "plan", "possible", "forecast", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "potential" or "continue", or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements.

These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by AEON and its management, are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the outcome of any legal proceedings that may be instituted against AEON or others; (ii) AEON’s future capital requirements, including with respect to potential obligations pursuant to the forward purchase agreements; (iii) AEON’s ability to raise financing in the future; (iv) AEON’s ability to continue to meet continued stock exchange listing standards; (v) the possibility that AEON may be adversely affected by other economic, business, regulatory, and/or competitive factors; and (vi) other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s filings with the Securities and Exchange Commission (the "SEC"), which are available on the SEC’s website at www.sec.gov.

Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. AEON does not undertake any duty to update these forward-looking statements.

Contacts

Investor Contact:
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

Source: AEON Biopharma

AEON BIOPHARMA, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share data and par value amounts)
		Successor				Successor
		June 30,				December 31,
		2024				2023
		(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents		$	3,442			$	5,158
Prepaid expenses and other current assets			577				1,064
Total current assets			4,019				6,222
Property and equipment, net			282				332
Operating lease right-of-use asset			1,404				262
Other assets			29				29
Total assets		$	5,734			$	6,845
LIABILITIES AND STOCKHOLDERS' DEFICIT
Current liabilities:
Accounts payable		$	3,030			$	3,388
Accrued clinical trials expenses			2,333				5,128
Accrued compensation			1,248				943
Other accrued expenses			3,818				3,590
Total current liabilities			10,429				13,049
Convertible notes at fair value, including related party amount of $13,292 and $0, at June 30, 2024 and December 31, 2023, respectively			13,292				—
Operating lease liability			1,262				—
Warrant liability			1,467				1,447
Contingent consideration liability			6,886				104,350
Embedded forward purchase agreements and derivative liabilities			345				41,043
Total liabilities			33,681				159,889
Commitments and contingencies
Stockholders’ Deficit:
Class A common stock, $0.0001 par value; 500,000,000 shares authorized at June 30, 2024 and December 31, 2023, and 39,122,238 and 37,159,600 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively			4				4
Additional paid-in capital			399,557				381,264
Subscription receivables			—				(60,710	)
Accumulated deficit			(427,508	)			(473,602	)
Total stockholders' deficit			(27,947	)			(153,044	)
Total liabilities and stockholders' deficit		$	5,734			$	6,845

AEON BIOPHARMA, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (in thousands, except share and per share data)
		Three Months Ended									Six Months Ended
		June 30,									June 30,
		2024					2023				2024					2023
		Successor					Predecessor				Successor					Predecessor
Operating expenses:
Selling, general and administrative		$	3,321				$	4,946			$	7,970				$	8,787
Research and development			4,439					9,025				10,172					18,230
Change in fair value of contingent consideration			(161,233	)				—				(97,464	)				—
Total operating costs and expenses			(153,473	)				13,971				(79,322	)				27,017
Income (loss) from operations			153,473					(13,971	)			79,322					(27,017	)
Other income (loss):
Change in fair value of convertible notes			1,795					(1,453	)			1,708					(6,110	)
Change in fair value of warrants			5,905					—				(14,999	)				—
Loss on embedded forward purchase agreements and derivative liabilities, net			2,905					—				(20,012	)				—
Other income, net			34					45				75					109
Total other income (loss), net			10,639					(1,408	)			(33,228	)				(6,001	)
Income (loss) before taxes			164,112					(15,379	)			46,094					(33,018	)
Income taxes			—					—				—					—
Net income (loss) and comprehensive income (loss)		$	164,112				$	(15,379	)		$	46,094				$	(33,018	)
Basic and diluted net income (loss) per share		$	4.22				$	(0.11	)		$	1.21				$	(0.24	)
Weighted average shares of common stock outstanding used to compute basic and diluted net income (loss) per share			38,843,627					138,825,356				38,055,850					138,825,356

The accompanying condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). The condensed consolidated financial statements include the accounts of the Company and its controlled subsidiaries.

On July 21, 2023, AEON completed the Merger with AEON Biopharma Sub, Inc. (“Old AEON”), with Old AEON surviving the merger as a wholly-owned subsidiary of the Company, the accounting acquirer. The transaction has been accounted for as a forward merger asset acquisition.

Unless the context otherwise requires, the “Company,” for periods prior to the close of the Merger, refers to Old AEON, currently AEON Biopharma Sub, Inc. (“Predecessor”), and for the periods after the close of the Merger, refers to AEON Biopharma, Inc., including AEON Biopharma Sub, Inc. (“Successor”). As a result of the Merger, the results of operations, financial position and cash flows of the Predecessor and Successor are not directly comparable. AEON Biopharma Sub, Inc. was deemed to be the Predecessor entity. Accordingly, the historical financial statements of AEON Biopharma Sub, Inc. became the historical financial statements of the combined Company, upon the consummation of the Merger. As a result, the financial statements included in this release reflect (i) the historical operating results of AEON Biopharma Sub, Inc. prior to the Merger and (ii) the combined results of the Company, including AEON Biopharma Sub, Inc., following the closing of the Merger. The accompanying financial statements include Predecessor periods for the three and six months ended June 30, 2023, and Successor periods for the three and six months ended June 30, 2024. A black line between the Successor and Predecessor periods has been placed in the condensed consolidated financial statements and in the tables to the notes to the condensed consolidated financial statements to highlight the lack of comparability between these periods.

FAQ

What is AEON Biopharma's (AEON) strategy for developing ABP-450?

AEON Biopharma is developing ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX®, utilizing the 351(k) regulatory pathway for biosimilars. This strategy aims to potentially secure approval for all of BOTOX's current and future therapeutic indications under a single approval.

When is AEON Biopharma (AEON) scheduled to meet with the FDA regarding ABP-450?

AEON Biopharma is scheduled to hold a biosimilar initial advisory meeting with the FDA in the third quarter of 2024.

What are AEON Biopharma's (AEON) plans for clinical trials of ABP-450?

AEON Biopharma plans to initiate a Phase 3 clinical study in cervical dystonia (CD) with approximately 400 patients, aiming to demonstrate non-inferiority of ABP-450 to BOTOX.

How might the biosimilar approach benefit AEON Biopharma (AEON) in bringing ABP-450 to market?

The biosimilar approach using the 351(k) regulatory pathway may allow AEON Biopharma to bring ABP-450 to the U.S. market more efficiently, potentially securing approval for multiple therapeutic indications under a single application.