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 November 3, 2022, REGENXBIO Inc. (the “Company”) issued a press release regarding its results of operations and financial condition for the quarter ended September 30, 2022. 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 November 3, 2022 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: |
November 3, 2022 |
By: |
/s/ Patrick J. Christmas II |
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Patrick J. Christmas II |
EXHIBIT 99.1
REGENXBIO Reports Third Quarter 2022 Financial Results and Recent Operational Highlights
ROCKVILLE, Md., November 3, 2022 (PRNewswire) -- REGENXBIO Inc. (Nasdaq: RGNX) today announced financial results for the third quarter ended September 30, 2022, and recent operational highlights.
“REGENXBIO has seen continued progress since our last earnings update, with encouraging data updates across four of our key gene therapy programs that make up our ‘5x’25’ strategy,” said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. “We shared multiple updates for our lead program, RGX-314, that is being developed in collaboration with AbbVie, including new long-term follow-up data for RGX-314 subretinal delivery that supports our anticipated 2024 BLA filing. We also shared new Phase II data for RGX-314 suprachoroidal delivery in both wet AMD and diabetic retinopathy. We are expanding these trials in both indications as we continue developing this novel approach to delivering gene therapy with the potential to expand patient access to the in-office setting. Within our rare disease pipeline, we also announced new data for RGX-121, our gene therapy for the treatment of MPS II, and we continue enrolling in the pivotal CAMPSIITE trial that we expect to support a planned BLA filing in 2024 using the accelerated approval pathway. We remain well funded to execute upon our goals and look forward to keeping you updated on the advancement of our programs as we finish the year and look ahead to 2023.”
Program Highlights and Milestones
RGX-314: RGX-314 is an investigational one-time AAV Therapeutic being developed in collaboration with AbbVie for the treatment of wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR)
and other additional chronic retinal conditions. RGX-314 uses the NAV® AAV8 vector to deliver a gene encoding a therapeutic antibody fragment to inhibit vascular endothelial growth factor (VEGF).
RGX-202: RGX-202 is an investigational one-time AAV Therapeutic for the treatment of Duchenne Muscular Dystrophy (Duchenne), using the NAV AAV8 vector to deliver a transgene for a novel microdystrophin that includes the functional elements of the C-Terminal (CT) domain as well as a muscle specific promoter to support a targeted therapy for improved resistance to muscle damage associated with Duchenne.
RGX-121: RGX-121 is an investigational one-time AAV Therapeutic for the treatment of Mucopolysaccharidosis Type II (MPS II), also known as Hunter Syndrome, using the NAV AAV9 vector to deliver the gene that encodes the iduronate-2-sulfatase (I2S) enzyme.
RGX-111: RGX-111 is an investigational one-time AAV Therapeutic for the treatment of severe Mucopolysaccharidosis Type I (MPS I), using the NAV AAV9 vector to deliver the α-l-iduronidase (IDUA) gene.
Operational Updates
NAV Technology Licensee Program Highlights
As of September 30, 2022, REGENXBIO's NAV Technology Platform was being applied in one marketed product and multiple clinical stage partnered programs, with the potential to impact a broad range of therapeutic areas and disease indications.
Financial Results
Cash Position: Cash, cash equivalents and marketable securities were $617.0 million as of September 30, 2022, compared to $849.3 million as of December 31, 2021. The decrease was primarily driven by cash used to fund operating activities and capital expenditures and temporary unrealized losses on marketable debt securities during the nine months ended September 30, 2022.
Revenues: Revenues were $26.5 million for the three months ended September 30, 2022, compared to $30.8 million for the three months ended September 30, 2021. The decrease was primarily attributable to Zolgensma royalty revenues, which decreased from $30.3 million for the third quarter of 2021 to $25.2 million for the third quarter of 2022. Zolgensma royalty revenues for the nine months ended September 30, 2022 were $75.1 million for the nine months ended September 30, 2022, compared to $66.9 million for the nine months ended September 30, 2021.
Research and Development Expenses: Research and development expenses were $63.3 million for the three months ended September 30, 2022, compared to $47.9 million for the three months ended September 30, 2021. The increase was primarily attributable to personnel costs as a result of increased headcount, and costs associated with clinical trials and manufacturing-related activities for our lead product candidates.
General and Administrative Expenses: General and administrative expenses were $20.9 million for the three months ended September 30, 2022, compared to $21.0 million for the three months ended September 30, 2021.
Net Loss: Net loss was $75.5 million, or $1.75 basic and diluted net loss per share, for the three months ended September 30, 2022, compared to a net loss of $58.4 million, or $1.37 basic and diluted net loss per share, for the three months ended September 30, 2021.
Financial Guidance
Based on its current operating plan, REGENXBIO expects its balance in cash, cash equivalents and marketable securities of $617.0 million as of September 30, 2022 to fund its operations into 2025.
Conference Call
In connection with this announcement, REGENXBIO will host a conference call and webcast today at 8:30 a.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. REGENXBIO's NAV Technology Platform, a proprietary adeno-associated virus (AAV) gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV Technology Platform Licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates, including late-stage and commercial programs, in multiple therapeutic areas. REGENXBIO is committed to a “5x’25” strategy to progress five AAV Therapeutics from our internal pipeline and licensed programs into pivotal-stage or commercial products by 2025.
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 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, the impact of the COVID-19 pandemic or similar public health crises on REGENXBIO's business, 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, 2021, 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.
REGENXBIO INC.
CONSOLIDATED BALANCE SHEETS
(unaudited)
(in thousands)
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September 30, 2022 |
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December 31, 2021 |
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Assets |
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Current assets |
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Cash and cash equivalents |
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$ |
118,544 |
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$ |
345,209 |
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Marketable securities |
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263,874 |
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112,230 |
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Accounts receivable, net |
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32,549 |
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32,439 |
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Prepaid expenses |
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14,824 |
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18,752 |
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Other current assets |
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6,848 |
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10,196 |
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Total current assets |
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436,639 |
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518,826 |
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Marketable securities |
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234,594 |
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391,907 |
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Accounts receivable, net |
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1,803 |
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2,262 |
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Property and equipment, net |
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140,906 |
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131,547 |
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Operating lease right-of-use assets |
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59,471 |
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60,904 |
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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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8,350 |
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6,428 |
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Total assets |
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$ |
883,793 |
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$ |
1,113,904 |
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Liabilities and Stockholders’ Equity |
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Current liabilities |
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Accounts payable |
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$ |
25,210 |
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$ |
11,387 |
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Accrued expenses and other current liabilities |
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44,462 |
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76,111 |
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Deferred revenue |
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5,903 |
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3,333 |
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Operating lease liabilities |
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3,608 |
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1,752 |
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Liability related to sale of future royalties |
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44,365 |
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37,889 |
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Total current liabilities |
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123,548 |
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130,472 |
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Operating lease liabilities |
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84,673 |
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84,929 |
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Liability related to sale of future royalties |
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103,084 |
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133,460 |
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Other liabilities |
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8,664 |
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745 |
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Total liabilities |
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319,969 |
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349,606 |
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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; 43,292 and 42,831 shares issued |
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4 |
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4 |
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Additional paid-in capital |
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963,694 |
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928,095 |
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Accumulated other comprehensive loss |
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(18,256 |
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(2,569 |
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Accumulated deficit |
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(381,618 |
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(161,232 |
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Total stockholders’ equity |
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563,824 |
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764,298 |
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Total liabilities and stockholders’ equity |
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$ |
883,793 |
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$ |
1,113,904 |
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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 |
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Nine Months |
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Ended September 30, |
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Ended September 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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Revenues |
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License and royalty revenue |
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$ |
26,512 |
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$ |
30,773 |
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$ |
81,379 |
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$ |
71,692 |
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Total revenues |
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26,512 |
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30,773 |
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81,379 |
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71,692 |
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Operating Expenses |
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Cost of revenues |
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13,094 |
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14,105 |
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41,762 |
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28,775 |
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Research and development |
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63,313 |
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47,855 |
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179,948 |
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133,459 |
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General and administrative |
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20,921 |
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21,030 |
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64,071 |
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57,293 |
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Credit losses and other |
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229 |
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5,131 |
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703 |
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5,781 |
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Total operating expenses |
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97,557 |
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88,121 |
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286,484 |
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225,308 |
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Loss from operations |
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(71,045 |
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(57,348 |
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(205,105 |
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(153,616 |
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Other Income (Expense) |
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Interest income from licensing |
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18 |
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117 |
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265 |
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700 |
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Investment income |
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1,497 |
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5,535 |
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3,357 |
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6,514 |
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Interest expense |
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(5,954 |
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(6,709 |
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(18,944 |
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(19,777 |
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Total other income (expense) |
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(4,439 |
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(1,057 |
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(15,322 |
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(12,563 |
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Loss before income taxes |
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(75,484 |
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(58,405 |
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(220,427 |
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(166,179 |
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Income Tax Benefit (Expense) |
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— |
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— |
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41 |
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(4 |
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Net loss |
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$ |
(75,484 |
) |
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$ |
(58,405 |
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$ |
(220,386 |
) |
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$ |
(166,183 |
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Other Comprehensive Loss |
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Unrealized loss on available-for-sale securities, net |
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(3,493 |
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(30 |
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(15,687 |
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(925 |
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Total other comprehensive loss |
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(3,493 |
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(30 |
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(15,687 |
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(925 |
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Comprehensive loss |
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$ |
(78,977 |
) |
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$ |
(58,435 |
) |
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$ |
(236,073 |
) |
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$ |
(167,108 |
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Net loss per share, basic and diluted |
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$ |
(1.75 |
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$ |
(1.37 |
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$ |
(5.11 |
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$ |
(3.93 |
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Weighted-average common shares outstanding, basic and diluted |
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43,251 |
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42,629 |
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43,103 |
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42,324 |
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###
Contacts:
Dana Cormack
Corporate Communications
dcormack@regenxbio.com
Investors:
Chris Brinzey, ICR Westwicke
339-970-2843
Chris.brinzey@westwicke.com