UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
On May 8, 2024, REGENXBIO Inc. (the “Company”) issued a press release regarding its results of operations and financial condition for the quarter ended March 31, 2024. The press release is furnished as Exhibit 99.1 to this Current Report on Form 8‑K and is incorporated by reference herein.
The information in Item 2.02 of this Current Report on Form 8‑K and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liability under that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
99.1 |
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Press release dated May 8, 2024 relating to REGENXBIO Inc.’s financial results. |
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104 |
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The cover page from this Current Report on Form 8-K, formatted in Inline XBRL. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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REGENXBIO INC. |
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Date: |
May 8, 2024 |
By: |
/s/ Patrick J. Christmas II |
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Patrick J. Christmas II
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EXHIBIT 99.1
REGENXBIO Reports First Quarter 2024 Financial Results and Recent Operational Highlights
ROCKVILLE, Md., May 8, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced financial results for the first quarter ending March 31, 2024. Recent operational highlights, including acceleration of the prioritized pipeline supports meaningful value generation from the Company's strong portfolio of AAV Therapeutics.
“Exciting program and data updates continue in 2024 and demonstrate remarkable progress on how REGENXBIO is rapidly advancing products through late-stage development,” said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. “We expect to make significant progress across our prioritized pipeline, including advancing our Duchenne program into pivotal stage and filing a BLA for RGX-121 this year, as well as finalizing plans to initiate a pivotal program in diabetic retinopathy early next year. Regardless of today’s landscape of Duchenne treatments, communication from the FDA continues to support the need for alternative gene therapies for rare diseases, including Duchenne. Our new, positive biomarker data from the AFFINITY DUCHENNE trial demonstrates the potential of RGX-202 as a meaningful and differentiated treatment option for the Duchenne community.”
PROGRAM HIGHLIGHTS AND MILESTONES
Neuromuscular Disease: RGX-202 is a potential one-time AAV therapeutic for the treatment of Duchenne.
Retinal Disease: ABBV-RGX‑314, in collaboration with AbbVie, is a potential one-time treatment for wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and other chronic retinal disease.
Neurodegenerative Disease: RGX-121 is a potential one-time AAV therapeutic for the treatment of boys with MPS II.
NAV® TECHNOLOGY PLATFORM LICENSEE PROGRAM HIGHLIGHTS
Novartis AG reported first quarter 2024 global sales of Zolgensma, for the treatment of spinal muscular atrophy, of $295 million. Novartis, Rocket Pharmaceuticals and Ultragenyx Pharmaceutical all have investigational AAV Therapeutics in pivotal phase that have multiple milestones expected throughout 2024. Eli Lilly is also developing several AAV Therapeutics in Phase II for neurodegenerative diseases using REGENXBIO NAV Technology.
FINANCIAL RESULTS
Cash Position: Cash, cash equivalents and marketable securities were $380.5 million as of March 31, 2024, compared to $314.1 million as of December 31, 2023. The increase was primarily attributable to $131.1 million of aggregate net proceeds received from the follow-on public offering of the Company's common stock and pre-funded warrants completed in March 2024, and was partially offset by cash used to fund operating activities during the first quarter of 2024.
Revenues: Revenues were $15.6 million for the three months ended March 31, 2024, compared to $19.1 million for the three months ended March 31, 2023. The decrease was primarily attributable to non-recurring development milestone revenue recognized in the first quarter of 2023, as well as Zolgensma royalty revenues, which decreased from $16.1 million in the first quarter of 2023 to $15.2 million in the first quarter of 2024.
Research and Development Expenses: Research and development expenses were $54.8 million for the three months ended March 31, 2024, compared to $58.5 million for the three months ended March 31, 2023. The decrease was primarily attributable to manufacturing and clinical supply costs for
ABBV-RGX-314 and RGX-202, and personnel-related costs as a result of reduced headcount of research and development personnel. The decrease was partially offset by increased clinical trial expenses across the Company's lead product candidates.
General and Administrative Expenses: General and administrative expenses were $18.3 million for the three months ended March 31, 2024, compared to $22.6 million for the three months ended March 31, 2023. The decrease was primarily attributable to personnel-related costs as a result of reduced headcount, expenses for professional services and other corporate overhead costs.
Net Loss: Net loss was $63.3 million, or $1.38 basic and diluted net loss per share, for the three months ended March 31, 2024, compared to a net loss of $66.7 million, or $1.53 basic and diluted net loss per share, for the three months ended March 31, 2023.
FINANCIAL GUIDANCE
REGENXBIO expects its balance in cash, cash equivalents and marketable securities of $380.5 million as of March 31, 2024 to fund its operations into 2026. This cash runway guidance is based on the Company’s current operational plans and excludes the impact of any payments that may be received from AbbVie upon the achievement of development or commercial milestones under our ABBV-RGX-314 collaboration (including a potential, one-time $200.0 million milestone for achievement of first patient dosed in the first pivotal trial for suprachoroidal delivery for treatment of DR) and the potential monetization of a priority review voucher that may be received for RGX-121.
CONFERENCE CALL
In connection with this announcement, REGENXBIO will host a conference call and webcast today at 4:30 p.m. ET. Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. A replay of the webcast will be available via the company’s investor website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.
ABOUT REGENXBIO Inc.
REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. Since its founding in 2009, REGENXBIO has pioneered the development of AAV Therapeutics, an innovative class of gene therapy medicines. REGENXBIO is advancing a pipeline of AAV Therapeutics for retinal and rare diseases, including ABBV-RGX-314 for the treatment of wet AMD and diabetic retinopathy, being developed in collaboration with AbbVie, RGX-202 for the treatment of Duchenne and RGX-121 for the treatment of MPS II. Thousands of patients have been treated with REGENXBIO’s AAV Therapeutic platform, including Novartis’ ZOLGENSMA® for children with spinal muscular atrophy. Designed to be one-time treatments, AAV Therapeutics have the potential to change the way healthcare is delivered for millions of people. For more information, please visit www.regenxbio.com.
FORWARD-LOOKING STATEMENTS
This press release includes "forward-looking statements," within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements express a belief, expectation or intention and are generally accompanied by words that convey projected future events or outcomes such as "believe," "may," "will," "estimate," "continue," "anticipate," "assume," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would" or by variations of such words or by similar expressions. The forward-looking statements include statements relating to, among other things, REGENXBIO's future operations, clinical trials, costs and cash flow. REGENXBIO has based these forward-looking statements on its current expectations and assumptions and analyses made by REGENXBIO in light of its experience and its
perception of historical trends, current conditions and expected future developments, as well as other factors REGENXBIO believes are appropriate under the circumstances. However, whether actual results and developments will conform with REGENXBIO's expectations and predictions is subject to a number of risks and uncertainties, including the timing of enrollment, commencement and completion and the success of clinical trials conducted by REGENXBIO, its licensees and its partners, the timing of commencement and completion and the success of preclinical studies conducted by REGENXBIO and its development partners, the timing or likelihood of payments from AbbVie, the monetization of any priority review voucher, the timely development and launch of new products, the ability to obtain and maintain regulatory approval of product candidates, the ability to obtain and maintain intellectual property protection for product candidates and technology, trends and challenges in the business and markets in which REGENXBIO operates, the size and growth of potential markets for product candidates and the ability to serve those markets, the rate and degree of acceptance of product candidates, and other factors, many of which are beyond the control of REGENXBIO. Refer to the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of REGENXBIO's Annual Report on Form 10-K for the year ended December 31, 2023, and comparable "risk factors" sections of REGENXBIO's Quarterly Reports on Form 10-Q and other filings, which have been filed with the U.S. Securities and Exchange Commission (SEC) and are available on the SEC's website at WWW.SEC.GOV. All of the forward-looking statements made in this press release are expressly qualified by the cautionary statements contained or referred to herein. The actual results or developments anticipated may not be realized or, even if substantially realized, they may not have the expected consequences to or effects on REGENXBIO or its businesses or operations. Such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Readers are cautioned not to rely too heavily on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this press release. Except as required by law, REGENXBIO does not undertake any obligation, and specifically declines any obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Zolgensma® is a registered trademark of Novartis Gene Therapies. All other trademarks referenced herein are registered trademarks of REGENXBIO.
REGENXBIO INC.
CONSOLIDATED BALANCE SHEETS
(unaudited)
(in thousands)
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March 31, 2024 |
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December 31, 2023 |
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Assets |
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Current assets |
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Cash and cash equivalents |
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$ |
112,975 |
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$ |
34,522 |
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Marketable securities |
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225,728 |
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240,736 |
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Accounts receivable, net |
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15,828 |
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24,790 |
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Prepaid expenses |
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13,590 |
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14,520 |
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Other current assets |
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27,297 |
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20,403 |
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Total current assets |
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395,418 |
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334,971 |
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Marketable securities |
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41,807 |
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38,871 |
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Accounts receivable |
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523 |
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701 |
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Property and equipment, net |
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127,662 |
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132,103 |
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Operating lease right-of-use assets |
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57,558 |
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60,487 |
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Restricted cash |
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2,030 |
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2,030 |
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Other assets |
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4,217 |
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4,807 |
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Total assets |
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$ |
629,215 |
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$ |
573,970 |
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Liabilities and Stockholders’ Equity |
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Current liabilities |
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Accounts payable |
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$ |
31,356 |
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$ |
22,786 |
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Accrued expenses and other current liabilities |
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33,129 |
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49,703 |
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Deferred revenue |
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13 |
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148 |
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Operating lease liabilities |
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7,066 |
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7,068 |
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Liability related to sale of future royalties |
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38,615 |
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50,567 |
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Total current liabilities |
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110,179 |
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130,272 |
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Operating lease liabilities |
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80,183 |
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82,222 |
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Liability related to sale of future royalties |
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44,702 |
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43,485 |
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Other liabilities |
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3,485 |
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6,249 |
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Total liabilities |
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238,549 |
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262,228 |
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Stockholders’ equity |
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Preferred stock; no shares issued and outstanding |
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— |
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— |
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Common stock; 49,043 and 44,046 shares issued |
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5 |
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4 |
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Additional paid-in capital |
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1,162,267 |
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1,021,214 |
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Accumulated other comprehensive loss |
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(3,229 |
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(4,429 |
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Accumulated deficit |
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(768,377 |
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(705,047 |
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Total stockholders’ equity |
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390,666 |
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311,742 |
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Total liabilities and stockholders’ equity |
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$ |
629,215 |
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$ |
573,970 |
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REGENXBIO INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
(in thousands, except per share data)
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Three Months Ended March 31, |
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2024 |
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2023 |
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Revenues |
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License and royalty revenue |
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$ |
15,622 |
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$ |
19,138 |
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Total revenues |
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15,622 |
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19,138 |
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Operating Expenses |
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Cost of revenues |
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4,283 |
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4,112 |
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Research and development |
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54,844 |
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58,516 |
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General and administrative |
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18,291 |
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22,634 |
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Impairment of long-lived assets |
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2,101 |
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— |
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Other operating expenses (income) |
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(34 |
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33 |
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Total operating expenses |
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79,485 |
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85,295 |
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Loss from operations |
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(63,863 |
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(66,157 |
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Other Income (Expense) |
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Interest income from licensing |
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37 |
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70 |
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Investment income |
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2,469 |
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2,166 |
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Interest expense |
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(1,973 |
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(2,755 |
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Total other income (expense) |
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533 |
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(519 |
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Net loss |
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$ |
(63,330 |
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$ |
(66,676 |
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Other Comprehensive Income |
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Unrealized gain on available-for-sale securities, net |
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1,200 |
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3,779 |
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Total other comprehensive income |
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1,200 |
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3,779 |
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Comprehensive loss |
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$ |
(62,130 |
) |
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$ |
(62,897 |
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Net loss per share, basic and diluted |
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$ |
(1.38 |
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$ |
(1.53 |
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Weighted-average common shares outstanding, basic and diluted |
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45,733 |
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43,451 |
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CONTACTS:
Dana Cormack
Corporate Communications
Dcormack@regenxbio.com
Chris Brinzey, ICR Westwicke
339-970-2843
Chris.Brinzey@westwicke.com