ASX Share rice
Tue 11 May 2021 - 06:13:pm (Sydney)

AVH Share Price

AVITA MEDICAL LTDAVHPharmaceuticals, Biotechnology & Life Sciences

AVH Company Information

Name:

AVITA Medical, Inc

Sector:

Healthcare

Industry:

Medical Devices

GIC Industry:

Biotechnology

GIC Sub Industry:

Biotechnology

Address:

28159 Avenue Stanford Valencia CA United States 91355

Phone:

661 367 9170

Full Time Employees:

98

CEO & Exec. Director:

Dr. Michael S. Perry D.V.M., DVM, Ph.D., FACVPT

Chief Technology Officer:

Mr. Andrew Quick

Gen. Counsel & Sec.:

Ms. Donna Shiroma

Chief Commercial Officer:

Ms. Erin Liberto

Chief Financial Officer:

Mr. Michael Bria Holder

VP of Global Operations:

Mr. David Fencil

Chief Operating Officer:

Ms. Kathy M. McGee

Sr. VP of Fin. & Principal Accounting Officer:

Mr. Sean Ekins

VP of Global Marketing:

Ms. Debbie Garner

Company Overview:

AVITA Medical Inc. operates as a commercial-stage regenerative tissue company in the United States, Australia, and the United Kingdom. It offers regenerative products to address unmet medical needs in burn injuries, trauma injuries, chronic wounds, and dermatological and aesthetics indications, including vitiligo. The company's patented and proprietary platform technology provides treatment solutions derived from the regenerative properties of a patient's own skin. Its lead product is RECELL System, a device that enables healthcare professionals to produce a suspension of Spray-On Skin cells using a small sample of the patient's own skin for use in the treatment of acute thermal burns in patients eighteen years and older. The company has a research collaboration with the University of Colorado School of Medicine to establish and explore development of a spray-on treatment for patients with epidermolysis bullosa; and a research collaboration with Houston Methodist Research Institute to explore novel approaches for skin rejuvenation. The company was formerly known as AVITA Therapeutics, Inc. and changed its name to AVITA Medical Inc. in December 2020. AVITA Medical Inc. is based in Valencia, California.

AVH Share Price Information

Shares Issued:

124.21M

Market Capitalisation:

$603.68M

Revenue (TTM):

$17.92M

Revenue Per Share (TTM):

$0.17

Earnings per Share:

$-0.028

Profit Margin:

-2.4463

Operating Margin (TTM):

$-2.47

Return On Assets (TTM):

$-0.34

Return On Equity (TTM):

$-0.60

Quarterly Revenue Growth (YOY):

0.566

Gross Profit(TTM):

$11.29M

Diluted Earnings Per Share (TTM):

$-0.522

AVH CashFlow Statement

CashFlow Date:

2020-06-30

Investments:

$-847,000

Change To Liabilities:

$2.44M

Total Cashflow From Investing Activities:

$-847,000

Net Borrowings:

$-42,000

Net Income:

$-42,030,000

Total Cash From Operating Activities:

$-22,747,000

Depreciation:

$465K

Change To Inventory:

$-468,000

Change To Account Receivables:

$-729,000

Capital Expenditures:

$590K

AVH Income Statement

Income Date:

2020-06-30

Income Before Tax:

$-42,026,000

Net Income:

$-42,030,000

Gross Profit:

$11.29M

Operating Income:

$-42,679,000

Other Operating Expenses:

$-3,926,000

Interest Expense:

$33K

Income Tax Expense:

$4K

Total Revenue:

$14.26M

Total Operating Expenses:

$56.94M

Cost Of Revenue:

$2.97M

AVH Balance Sheet

Balance Sheet Date:

2020-06-30

Intangible Assets:

$364K

Total Liabilities:

$10.06M

Total Stockholder Equity:

$72.40M

Other Current Liabilities:

$16K

Total Assets:

$82.46M

Common Stock:

$3K

Other Current Assets:

$324K

Retained Earnings:

$-194,913,000

Other Liabilities:

$435K

Other Assets:

$1K

Cash:

$73.64M

Total Current Liabilities:

$7.71M

Property - Plant & Equipment:

$3.71M

Net Tangible Assets:

$72.04M

Total Current Assets:

$78.39M

Net Receivables:

$2.51M

Short-Term Investments:

$4.08M

Inventory:

$1.13M

Accounts Payable:

$4.33M

Non Currrent Assets (Other):

$1K

Short-Term Investments:

$4.08

Non Current Liabilities Total:

$2.35M

AVH Share Price History

AVH News

29 Apr, 2021
VALENCIA, Calif. and MELBOURNE, Australia, April 29, 2021 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (Company), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today it plans to release its fiscal third quarter 2021 financial results after the market closes on Thursday, May 13, 2021. In conjunction with the release, the Company plans to host a conference call and webcast on May 13th at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time (being 6:30am Australian Eastern Daylight Time on Friday, May 14) to discuss its financial results and recent highlights. Interested parties may access the live call via telephone by dialing (833)-614-1538 for domestic callers or (706)-634-6548 for international callers, using conference ID: 5490156. The live webinar of the call may be accessed by visiting the Events section of the Company’s website at ir.avitamedical.com. A replay of the webinar will be available on the Company’s website shortly after the conclusion of the call. Authorized for release by the Chief Financial Officer of AVITA Medical, Inc. ABOUT AVITA MEDICAL, INC.AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical’s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a RES® REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment. AVITA Medical’s first U.S. product, the RECELL® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin™ Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 10,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL® Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions. In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe. To learn more, visit www.avitamedical.com. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This letter includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this letter include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this letter is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the company’s control. Investors should not place considerable reliance on the forward-looking statements contained in this letter. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this letter speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements. This press release was authorized by the review committee of AVITA Medical, Inc. FOR FURTHER INFORMATION: U.S. Media Sam Brown, Inc. Christy Curran Phone +1-615-414-8668 christycurran@sambrown.com O.U.S. Media Rudi Michelson Phone +61 (0)3 9620 3333 Mobile +61 (0)411 402 737 rudim@monsoon.com.au Investors Westwicke Partners Caroline Corner Phone +1-415-202-5678 caroline.corner@westwicke.com
15 Apr, 2021
Presentations include data highlighting real-world use of RECELL in combination with complementary treatments, clinical versatility, and cost effectiveness of RECELL to advance patient careVALENCIA, Calif. and MELBOURNE, Australia., April 15, 2021 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, today announced that nine abstracts highlighting the clinical and cost-savings benefits of the RECELL® Autologous Cell Harvesting Device (RECELL® System) have been accepted at the 43rd Annual John A. Boswick Burn & Wound Care Symposium. The international conference will be held in Maui, Hawaii, April 17-22, 2021, and covers the latest advancements in burn care, wound healing, and infection control. “The strong presence and broad range of physician-initiated data at this year’s Boswick Symposium reflects the rapidly expanding use of the RECELL System to treat burns of varying depth and size, as well as in combination with complementary surgical technologies, to advance patient care,” said Dr. Mike Perry, AVITA Medical’s Chief Executive Officer. “We remain committed to partnering with physicians and progressing our pipeline to realize the full potential of this innovative technology platform to treat a wide array of skin defects and wounds.” RECELL System Accepted Abstracts A Real World Economic Evaluation of the Cost-Effectiveness of Autologous Cell Harvesting Device for the Treatment of Burns Requiring Hospitalization. Author: W Hickerson, Memphis, TNAutologous Skin Cell Suspension Early in the Acute Thermal Burn Injury Treatment Pathway: A Single Institution Experience. Author: N Kopari, Community Regional Medical Center, Fresno, CACase Review Using Autologous Skin Cell Suspension in Combination with Widely Meshed Split-Thickness Autografts in the Treatment of Complex Soft Tissue Injuries. Author: N Kopari, Community Regional Medical Center, Fresno, CACombining Two State-of-the-Art Surgical Techniques for the Treatment of Deep Second-Degree Burns. Author: S Blome-Eberwein, Lehigh Valley Hospital, Allentown, PAEvolving Concepts for RECELL Use. Author: R Sood, Burn and Reconstructive Centers of America, Augusta, GAEvolving Concepts in the Management of Coverage of Large Burns. Author: R Sood, Burn and Reconstructive Centers of America, Augusta, GAImplementing Autologous Skin Cell Suspension at an ABA Burn Center: A Comparison of Operative Efficiency using RECELL Versus Standard Split Thickness Autografting. Author: K Skibba, University of Rochester, NYOptimal Donor Sites for Autologous Cell Suspension Device (RECELL) in Pediatric Burn Reconstruction. Author: B Temple, St. Christopher's Hospital for Children, Philadelphia, PARITA: A Simulation Based Training Program to Replicate Real-Life Wound Care Experiences in Burns Treated with Autologous Skin Cell Suspension. Author: C Bell, AVITA Medical, Valencia, CA For more information about the RECELL System, please visit https://recellsystem.com/. ABOUT AVITA MEDICAL, INC.AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical’s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a RES® REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment. AVITA Medical’s first U.S. product, the RECELL® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin™ Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 10,000 patients globally reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL® Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings, and precautions. In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds, and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe. To learn more, visit www.avitamedical.com. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTSThis letter includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this letter include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this letter is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the company’s control. Investors should not place considerable reliance on the forward-looking statements contained in this letter. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this letter speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements. This press release was authorized by the review committee of AVITA Medical, Inc. FOR FURTHER INFORMATION: U.S. MediaSam Brown, Inc.Christy CurranPhone +1-615-414-8668christycurran@sambrown.comO.U.S. MediaRudi Michelson Phone +61 (0)3 9620 3333 Mobile +61 (0)411 402 737 rudim@monsoon.com.auInvestorsWestwicke PartnersCaroline CornerPhone +1-415-202-5678 caroline.corner@westwicke.com
14 Apr, 2021
AVITA Medical, Inc. (RCEL) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.
30 Mar, 2021
Record Number of Accepted Abstracts Highlight Benefits of RECELL System and Reinforce Rapid Adoption by Surgeons to Advance Burn CareVALENCIA, Calif. and MELBOURNE, Australia, March 30, 2021 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, today announced that 15 abstracts highlighting the clinical and cost-savings benefits of the RECELL® Autologous Cell Harvesting Device (RECELL® System) have been accepted at the American Burn Association (ABA) 53rd Annual Meeting. The meeting, which will be held virtually April 7-9, 2021, annually brings together more than 2,000 multi-disciplinary burn care professionals from around the world. “This year’s ABA meeting features the highest number of presentations on the clinical and health economic benefits of the RECELL System since its U.S. Food and Drug Administration approval in 2018,” said Dr. Mike Perry, AVITA Medical’s Chief Executive Officer. “The acceptance and adoption of RECELL is reflected in these physician-initiated presentations, representing the collective experience of 20 burn centers. With more than 80% of burn surgeons in the United States now certified in the use of the RECELL System, we are encouraged by their continuing exploration of RECELL in the treatment of various burn depths and sizes, and we remain committed to enabling the realization of the full potential of this innovative platform technology.” RECELL® System Accepted Abstracts Outcomes for Hand Burns Treated with Autologous Skin Cell Suspension in 20% TBSA and Smaller Injuries. Author: M Taylor, Tulane University School of Medicine, New Orleans, LAAutologous Skin Cell Suspension (ASCS) for the Treatment of Small (
22 Mar, 2021
VALENCIA, Calif. and MELBOURNE, Australia, March 22, 2021 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (Nasdaq: RCEL; ASX: AVH) (“AVITA Medical”), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today the appointment of Michael Holder as Chief Financial Officer effective March 22, 2021. Mr. Holder will assume responsibility for overseeing the global finance, accounting, M&A, and investor relations functions and will be based in AVITA’s Valencia office in California. “Michael’s extensive background in finance, M&A, business development, strategy, and operations, along with his demonstrated track record of creating and realizing shareholder value for private and public companies in the cell and gene therapy and other industries, will certainly strengthen our leadership team,” said Dr. Mike Perry, AVITA Medical’s Chief Executive Officer. Mr. Holder commented, “I am excited to join the AVITA Medical team. I believe the opportunity for growth at Avita Medical is tremendous given its initial FDA approved burn indication, promising clinical portfolio, development pipeline, M&A related opportunities, and its smart and dedicated team operating with Dr. Perry’s leadership.” A seasoned executive with more than 25 years of experience, Mr. Holder has served in senior financial, executive management, and board roles with leading private and public companies in the medtech, biotech, and pharma related industries. Most recently, he served as Chief Financial Officer with ImmuneCyte, Inc., a global clinical stage biopharmaceutical company with innovative cell and gene immune-oncology therapeutics. At ImmuneCyte, Inc., Mr. Holder led preparations for a major IPO or SPAC transaction and was responsible for the development of financial team and infrastructure capital raises, M&A, and external audits. Prior to ImmuneCyte, Inc., Mr. Holder was CEO and Portfolio Manager at Carolina Longevity Institute, LLC, a global investment company focused on investments in medtech, biotech and pharma companies that improve healthspan and longevity. At Carolina Longevity Institute, LLC, Mr. Holder managed all investment, financial, administrative, corporate development, and operational activities. Prior to Carolina Longevity Institute, LLC, Mr. Holder was initially CFO and later Chairman and CEO at Organ Transport Systems, Inc., a medical device company, where he built the company from early stage through multiple financing rounds as well as research, regulatory, and commercial launch activities. Prior to Organ Transport Systems, Inc., Mr. Holder was the CFO of three public or private medtech and pharma related companies. Mr. Holder holds a Master of Business Administration from the Wharton School of Business at the University of Pennsylvania, a Bachelor of Science in Business Administration from the Kenan-Flagler Business School at the University of North Carolina., and previously obtained his CPA. About AVITA Medical, Inc.: AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical’s proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a RES® REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment. AVITA Medical’s first U.S. product, the RECELL® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin™ Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 10,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL® Autologous Cell Harvesting Device for a full description of indications for use and important safety information including contraindications, warnings and precautions. In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe. For Further Information: U.S. MediaSam Brown, Inc. Christy CurranPhone +1-615-414-8668christycurran@sambrown.comO.U.S. MediaRudi Michelson Phone +61 (0)3 9620 3333Mobile +61 (0)411 402 737rudim@monsoon.com.auInvestorsWestwicke PartnersCaroline Corner Phone +1-415-202-5678caroline.corner@westwicke.com
01 Mar, 2021
VALENCIA, Calif. and MELBOURNE, Australia, March 01, 2021 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (Nasdaq: RCEL; ASX: AVH) (“AVITA Medical”), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, today announced the successful closing of an underwritten registered public offering of its shares of common stock, the details of which were released to the market on February 24, 2021 (United States) / February 25, 2021 (Australia). AVITA Medical has issued 3,214,250 shares of common stock at the offering price of US$21.50 per share. This amount includes 419,250 shares of common stock issued upon the exercise in full by the underwriters of their option to purchase additional shares. The gross proceeds from the offering are approximately US$69.1 million, before deducting underwriting discounts and commissions and estimated offering expenses. AVITA Medical expects to use the net proceeds from the offering to fund its product development pipeline, to pursue approvals of its products for additional indications and for general corporate purposes, which may include licensing arrangements. Piper Sandler & Co. and Cowen and Company, LLC acted as joint book-running managers for the offering. BTIG, LLC acted as lead manager and Lake Street Capital Markets, LLC acted as co-manager for the offering. The offering was made pursuant to a shelf registration statement on Form S-3 (File No. 333-249419) that was previously filed with the Securities and Exchange Commission (the “SEC”) on October 9, 2020 and declared effective on October 16, 2020 and that was also publicly released on the Australian Securities Exchange (“ASX”). The final prospectus supplement relating to and describing the terms of the offering was filed with the SEC and released on the ASX on February 25, 2021 (in the United States) / March 1, 2021 (in Australia). A copy of these documents may be obtained by visiting EDGAR on the SEC's website at www.sec.gov or by contacting Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by e-mail at prospectus@psc.com, or by phone at (800) 747-3924, or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at PostSaleManualRequests@broadridge.com. This announcement shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About AVITA Medical, Inc.: AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical’s proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a RES® REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment. AVITA Medical’s first U.S. product, the RECELL® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin™ Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 10,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL® Autologous Cell Harvesting Device for a full description of indications for use and important safety information including contraindications, warnings and precautions. In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe. Forward-Looking Statements: This announcement contains “forward-looking statements” within the meaning of Section 27A of the Private Securities Litigation Reform Act of 1995. Although the forward-looking statements in this announcement reflect the good faith judgment of management, forward-looking statements are inherently subject to known and unknown risks and uncertainties that may cause actual results to be materially different from those discussed in these forward-looking statements. Readers are urged to carefully review and consider the various disclosures made by AVITA Medical in the reports it has filed with the SEC, including the “Risk Factors” section of the Company’s Annual Report 10-K for the year ended June 30, 2020 for a description of the risks that may affect its business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, AVITA Medical’s actual results may vary materially from those expected or projected. Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this announcement. AVITA Medical assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this announcement, except as required by law. For Further Information: U.S. MediaSam Brown, Inc. Christy CurranPhone +1-615-414-8668christycurran@sambrown.com O.U.S. MediaRudi Michelson Phone +61 (0)3 9620 3333Mobile +61 (0)411 402 737rudim@monsoon.com.au InvestorsWestwicke PartnersCaroline Corner Phone +1-415-202-5678caroline.corner@westwicke.com
25 Feb, 2021
VALENCIA, Calif. and MELBOURNE, Australia, Feb. 25, 2021 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (Nasdaq: RCEL; ASX: AVH) (“AVITA Medical”), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, today announced the pricing of its previously announced underwritten registered public offering of 2,795,000 shares of its common stock at a public offering price of US$21.50 per share. As part of the offering, AVITA Medical granted the underwriters a 30-day option to purchase at the public offering price up to an additional 419,250 shares of its common stock on the same terms and conditions. All of the shares of common stock to be sold in the offering are being offered by AVITA Medical. AVITA Medical expects to close the offering on or about March 1, 2021, subject to the satisfaction of customary closing conditions. Gross proceeds from the offering are expected to be approximately US$60.1 million assuming no exercise of the underwriter’s option to purchase additional shares. AVITA Medical intends to use the net proceeds from this offering (after deducting the underwriting discounts and commissions and other estimated offering expenses payable by AVITA Medical) to fund its current product development pipeline, to pursue approvals of its products for additional indications and for general corporate purposes, which may include licensing arrangements. Piper Sandler & Co. and Cowen and Company, LLC are acting as joint book-running managers for the offering. BTIG, LLC is acting as lead manager and Lake Street Capital Markets, LLC is acting as co-manager for the offering. The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-249419) that was previously filed with the Securities and Exchange Commission (the “SEC”) on October 9, 2020 and declared effective on October 16, 2020 and that was also publicly released on the Australian Securities Exchange (“ASX”). A preliminary prospectus supplement and accompanying prospectus related to and describing the terms of the proposed offering have been filed with the SEC and released on the ASX on February 24, 2021 (in the United States) / February 25, 2021 (in Australia). A copy of these documents may be obtained by visiting EDGAR on the SEC's website at www.sec.gov or by contacting Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by e-mail at prospectus@psc.com, or by phone at (800) 747-3924, or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at PostSaleManualRequests@broadridge.com. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC and released on the ASX. This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About AVITA Medical, Inc.: AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical’s proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a RES® REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment. AVITA Medical’s first U.S. product, the RECELL® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin™ Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 10,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL® Autologous Cell Harvesting Device for a full description of indications for use and important safety information including contraindications, warnings and precautions. In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe. Forward-Looking Statements: This press release contains “forward-looking statements” within the meaning of Section 27A of the Private Securities Litigation Reform Act of 1995. Although the forward-looking statements in this release reflect the good faith judgment of management, forward-looking statements are inherently subject to known and unknown risks and uncertainties that may cause actual results to be materially different from those discussed in these forward-looking statements. Readers are urged to carefully review and consider the various disclosures made by AVITA Medical in the reports it has filed with the SEC, including the “Risk Factors” section of the Company’s Annual Report 10-K for the year ended June 30, 2020 for a description of the risks that may affect its business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, AVITA Medical’s actual results may vary materially from those expected or projected. Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. AVITA Medical assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release, except as required by law. For Further Information: U.S. MediaSam Brown, Inc. Christy CurranPhone +1-615-414-8668christycurran@sambrown.comO.U.S. MediaRudi Michelson Phone +61 (0)3 9620 3333Mobile +61 (0)411 402 737rudim@monsoon.com.auInvestorsWestwicke PartnersCaroline Corner Phone +1-415-202-5678caroline.corner@westwicke.com
24 Feb, 2021
VALENCIA, Calif. and MELBOURNE, Australia, Feb. 24, 2021 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (Nasdaq: RCEL; ASX: AVH) (“AVITA Medical”), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, today announced that it has commenced an underwritten registered public offering of its common stock. In addition, AVITA Medical is expected to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock sold in the offering on the same terms and conditions. All of the shares of common stock to be sold in the proposed offering will be offered by AVITA Medical. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. AVITA Medical intends to use the net proceeds from this proposed offering to fund its current product development pipeline, to pursue approvals of its products for additional indications and for general corporate purposes, which may include licensing arrangements. Piper Sandler & Co. and Cowen and Company, LLC are acting as joint book-running managers for the proposed offering. The proposed offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-249419) that was previously filed with the Securities and Exchange Commission (the “SEC”) on October 9, 2020 and declared effective on October 16, 2020 and that was also publicly released on the Australian Securities Exchange (“ASX”). A preliminary prospectus supplement and accompanying prospectus related to and describing the terms of the proposed offering have been filed with the SEC and may be obtained by visiting EDGAR on the SEC's website at www.sec.gov or by contacting Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by e-mail at prospectus@psc.com, or by phone at (800) 747-3924, or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at PostSaleManualRequests@broadridge.com. The final terms of the proposed offering will be disclosed in a final prospectus supplement to be filed with the SEC and released on the ASX. This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About AVITA Medical, Inc.: AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical’s proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a RES® REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment. AVITA Medical’s first U.S. product, the RECELL® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin™ Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 10,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL® Autologous Cell Harvesting Device for a full description of indications for use and important safety information including contraindications, warnings and precautions. In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe. Forward-Looking Statements: This press release contains “forward-looking statements” within the meaning of Section 27A of Private Securities Litigation Reform Act of 1995. Although the forward-looking statements in this release reflect the good faith judgment of management, forward-looking statements are inherently subject to known and unknown risks and uncertainties that may cause actual results to be materially different from those discussed in these forward-looking statements. Readers are urged to carefully review and consider the various disclosures made by AVITA Medical in the reports it has filed with the SEC, including the “Risk Factors” section of the Company’s Annual Report 10-K for the year ended June 30, 2020 for a description of the risks that may affect its business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, AVITA Medical’s actual results may vary materially from those expected or projected. Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. AVITA Medical assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release, except as required by law. For Further Information: U.S. MediaSam Brown, Inc. Christy CurranPhone +1-615-414-8668christycurran@sambrown.comO.U.S. MediaRudi Michelson Phone +61 (0)3 9620 3333Mobile +61 (0)411 402 737rudim@monsoon.com.auInvestorsWestwicke PartnersCaroline Corner Phone +1-415-202-5678caroline.corner@westwicke.com
18 Feb, 2021
VALENCIA, Calif. and MELBOURNE, Australia, Feb. 18, 2021 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today that its management will present at the following upcoming investor conferences: Cowen 41st Annual Healthcare ConferencePresenting on Thursday, March 4, 2021 at 11:10 a.m. Pacific Time / 2:10 p.m. Eastern Time (Australian time: Friday, March 5, 2021 at 6:10 a.m.) Oppenheimer 31st Annual Healthcare ConferencePresenting on Tuesday, March 16, 2021 at 12:50 p.m. Pacific Time / 3:50 p.m. Eastern Time (Australian time: Wednesday, March 17, 2021 at 7:50 a.m.) The live, audio-only webcasts of the presentations may be accessed by visiting ir.avitamedical.com. The replays of the webcasts will be available shortly after the conclusion of the presentations and will be archived on AVITA Medical’s website for 30 days following the presentations. Authorized for release by the Chief Executive Officer of AVITA Medical, Inc. ABOUT AVITA MEDICAL, INC.AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical’s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a RES® REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment. AVITA Medical’s first U.S. product, the RECELL® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin™ Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 10,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL® Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions. In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe. To learn more, visit www.avitamedical.com. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This letter includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this letter include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward- looking statement contained in this letter is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the company’s control. Investors should not place considerable reliance on the forward-looking statements contained in this letter. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this letter speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements. This press release was authorized by the review committee of AVITA Medical, Inc. FOR FURTHER INFORMATION: U.S. MediaSam Brown, Inc.Christy CurranPhone +1-615-414-8668christycurran@sambrown.comO.U.S. MediaRudi Michelson Phone +61 (0)3 9620 3333 Mobile +61 (0)411 402 737 rudim@monsoon.com.auInvestorsWestwicke PartnersCaroline CornerPhone +1-415-202-5678 caroline.corner@westwicke.com
11 Feb, 2021
VALENCIA, Calif. and MELBOURNE, Australia, Feb. 11, 2021 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX:AVH) (Company), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, today reported financial results for its second quarter of fiscal year 2021, ended December 31, 2020. Second Quarter Highlights Reported U.S based RECELL® revenue of $5.0 million in the second quarter of 2021 ended December 31, 2020, a 62% increase over the same quarter in the prior yearReported total global revenue of $5.1 million in the second quarter of 2021 ended December 31, 2020, a 57% increase over the same quarter in the prior yearCommercial metrics:° Procedural volumes were 487 in the second quarter of 2021 versus 496 in the prior quarter ended September 30, 2020° Added 7 new accounts in the second quarter 2021 for a total of 93 accountsEnrolled nine patients in the pivotal study assessing the use of the RECELL® System to treat stable vitiligo “I’m proud of our progress over the last quarter as we strive to broaden the applications of our platform to serve patients both within burns and beyond. With our burn center account base now mostly built out, our sales team is poised and ready to drive utilization as the pandemic abates and we regain access to hospitals and patients,” said Dr. Mike Perry, AVITA Medical Chief Executive Officer. “We have continued to make strong progress with our vitiligo pivotal trial, seeing very encouraging interest and enrollment trends, and we believe this could put us in a position to file for FDA approval in 2022.” Second Quarter 2021 Financial ResultsTotal global revenue was $5.1 million in the second quarter of 2021, compared to $3.3 million for the same quarter last year and flat to the prior quarter ended September 30, 2020. Gross margin was 84% for the second quarter of 2021, compared with 74% in the same quarter last year, driven largely by the extension of our shelf-life along with lower shipping costs and increased production. Operating expenses were $10.4 million for the second quarter of 2021, compared with $13.4 million in the same quarter last year. The decrease was primarily attributable to lower stock-based compensation along with lower legal costs, partially offset by the ramping up of clinical trials for treatment of vitiligo and pediatric scald injuries and other research and developments costs to further expand the Company’s pipeline. Lower stock-based compensation is as a result of a reversal for unvested stock awards due to the resignation of an executive officer. Net loss was $5.6 million for the second quarter of 2021 and net loss per share was $0.26 on a weighted-average basic and diluted share count of 21.6 million, compared to $10.5 million and a net loss per share of $0.53 on a weighted-average basic and diluted share count of 19.9 million in the same period of the prior year. Cash was $59.8 million as of December 31, 2020. Outlook and COVID-19Due to uncertainty surrounding the COVID-19 pandemic, the Company will not provide financial guidance at this time. Nearly half of the Company’s revenues come from twenty accounts with physicians and hospitals. These accounts are susceptible to the effects of COVID-19 and COVID-19 restrictions. To the extent that COVID-19 or other factors cause such physicians or hospitals to be unable to treat patients or delay the treatment of patients using the RECELL System in a particular quarter, or make patients unavailable because of COVID-19, our revenues could be negatively affected. Due to these uncertainties, providing guidance at this time is not feasible. Webcast and Conference Call InformationThe Company will host a conference call to discuss the second quarter financial results after market close on Thursday, February 11, 2021 at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time (being 8.30am Australian Eastern Daylight Time on Friday, February 12, 2021). The conference call can be accessed live over the phone (833) 614-1538 for U.S. callers or (706) 634-6548 for international callers, using conference ID: 5047528. The live webinar can be accessed at https://ir.avitamedical.com. Authorized for release by the Chief Executive Officer of AVITA Medical, Inc. ABOUT AVITA Medical, INC.AVITA Medical, Inc. is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical Inc. patented, and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a RES® REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment. AVITA Medicals’ first U.S. product, the RECELL® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin™ Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 8,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL® Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions. In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe.To learn more, visit www.avitamedical.com. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTSThis letter includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this letter include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward- looking statement contained in this letter is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions including, but not limited to the ongoing COVID-19 pandemic which are outside of the company’s control. Investors should not place considerable reliance on the forward-looking statements contained in this letter. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this letter speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements. FOR FURTHER INFORMATION: U.S. MediaSam Brown, Inc.Christy CurranPhone +1 615 414 8668christycurran@sambrown.comO.U.S MediaMonsoon CommunicationsRudi MichelsonPhone +61 (0)3 9620 3333Mobile +61 (0)411 402 737rudim@monsoon.com.auInvestorsWestwicke PartnersCaroline CornerPhone +1 415 202 5678caroline.corner@westwicke.com AVITA MEDICAL, INC. Consolidated Balance Sheets (In thousands, except share and per share data) (Unaudited) As of December 31, 2020 June 30, 2020 ASSETS Cash$59,765 $73,639 Accounts receivable, net 1,941 2,076 BARDA receivables 440 356 Prepaids and other current assets 814 990 Restricted cash 201 201 Inventory 2,289 1,125 Total current assets 65,450 78,387 Plant and equipment, net 1,488 1,363 Operating lease right-of-use assets 1,795 2,347 Intangible assets, net 420 364 Other long-term assets 152 1 Total assets$69,305 $82,462 LIABILITIES AND SHAREHOLDERS’ EQUITY Accounts payable and accrued liabilities$2,793 $4,333 Accrued wages and fringe benefits 4,305 2,816 Other current liabilities 775 560 Total current liabilities 7,873 7,709 Contract liabilities 596 435 Operating lease liabilities, long term 1,239 1,917 Total liabilities 9,708 10,061 Contingencies (Note 10) Shareholders’ Equity: Common stock, $0.0001 par value per share, 200,000,000 shares authorized, 21,625,058 and 21,467,912 shares issued and outstanding at December 31, 2020 and June 30, 2020, respectively 3 3 Preferred stock, $0.0001 par value per share, 10,000,000 shares authorized, no shares issued or outstanding at December 31, 2020 and June 30, 2020 - - Additional paid-in capital 262,086 259,165 Accumulated other comprehensive income 8,289 8,146 Accumulated deficit (210,781) (194,913) Total shareholders’ equity 59,597 72,401 Total liabilities and shareholders’ equity$69,305 $82,462 AVITA MEDICAL, INC. Consolidated Statements of Operations (In thousands, except share and per share data) (Unaudited) Three months ended December 31, Six months ended December 31, 2020 2019 2020 2019 Revenues$5,103 $3,259 $10,163 $6,509 Cost of sales 821 846 1,750 1,465 Gross profit 4,282 2,413 8,413 5,044 BARDA income 449 386 1,045 2,437 Operating expenses: Sales and marketing expenses 3,600 3,972 6,865 7,071 General and administrative expenses 3,401 7,107 11,703 10,529 Research and development expenses 3,361 2,312 6,735 4,131 Total operating expenses 10,362 13,391 25,303 21,731 Operating loss (5,631) (10,592) (15,845) (14,250)Interest expense 3 9 10 20 Other income/(expense) 4 99 8 202 Loss before income taxes (5,630) (10,502) (15,847) (14,068)Income tax expense 11 - 21 - Net loss$(5,641) $(10,502) $(15,868) $(14,068)Net loss per common share: Basic$(0.26) $(0.53) $(0.74) $(0.73)Diluted$(0.26) $(0.53) $(0.74) $(0.73)Weighted-average common shares: Basic 21,623,509 19,877,676 21,563,576 19,298,767 Diluted 21,623,509 19,877,676 21,563,576 19,298,767 Total operating expenses include impact of share-based compensation as follows: Three Months Ended December 31, Six Months Ended December 31, 2020 2019 2020 2019Sales and marketing expenses$294 $234 $624 $370General and administrative expenses (774) 2,549 1,992 2,900Research and development expenses 134 120 304 305Total$(346) $2,903 $2,920 $3,575
NEW YORK, NY / ACCESSWIRE / February 11, 2021 / Avita Medical Limited - ADR (NASDAQ:RCEL) will be discussing their earnings results in their 2021 Second Quarter Earnings call to be held on February 11, 2021 at 4:30 PM Eastern Time.Investor NetworkNEW YORK, NY / ACCESSWIRE / February 11, 2021 / Avita Medical Limited - ADR (NASDAQ:RCEL) will be discussing their earnings results in their 2021 Second Quarter Earnings call to be held on February 11, 2021 at 4:30 PM Eastern Time.
07 Feb, 2021
A look at the shareholders of AVITA Medical, Inc. ( ASX:AVH ) can tell us which group is most powerful. Generally...
03 Feb, 2021
VALENCIA, Calif. and MELBOURNE, Australia, Feb. 03, 2021 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today that its management will present at the BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference on Wednesday, February 17, 2021 at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time (February 18, 2021 at 8:30 am Melbourne time). Authorized for release by the Chief Executive Officer of AVITA Medical, Inc. ABOUT AVITA MEDICAL, INC.AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical’s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a RES® REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment. AVITA Medical’s first U.S. product, the RECELL® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin™ Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 10,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL® Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions. In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe. To learn more, visit www.avitamedical.com. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This letter includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this letter include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this letter is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the company’s control. Investors should not place considerable reliance on the forward-looking statements contained in this letter. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this letter speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements. This press release was authorized by the review committee of AVITA Medical, Inc. FOR FURTHER INFORMATION: U.S. MediaSam Brown, Inc.Christy CurranPhone +1-615-414-8668christycurran@sambrown.comO.U.S. MediaRudi Michelson Phone +61 (0)3 9620 3333 Mobile +61 (0)411 402 737 rudim@monsoon.com.auInvestorsWestwicke PartnersCaroline CornerPhone +1-415-202-5678 caroline.corner@westwicke.com
28 Jan, 2021
VALENCIA, Calif. and MELBOURNE, Australia, Jan. 28, 2021 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today it plans to release its fiscal second quarter 2021 financial results after the market closes on Thursday, February 11, 2021. In conjunction with such release, the Company plans to host a conference call and webcast on February 11th at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time to discuss its financial results and recent highlights. Interested parties may access the live call via telephone by dialing (833) 614-1538 for domestic callers or (706) 634-6548 for international callers, using conference ID: 5047528. The live webinar of the call may be accessed by visiting the Events section of the Company’s website at ir.avitamedical.com. A replay of the webinar will be available on the Company’s website shortly after the conclusion of the call. Authorized for release by the Chief Executive Officer of AVITA Medical, Inc. ABOUT AVITA MEDICAL, INC.AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical’s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a RES® REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment. AVITA Medical’s first U.S. product, the RECELL® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin™ Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 10,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL® Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions. In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe. To learn more, visit www.avitamedical.com. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This letter includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this letter include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward- looking statement contained in this letter is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the company’s control. Investors should not place considerable reliance on the forward-looking statements contained in this letter. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this letter speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements. This press release was authorized by the review committee of AVITA Medical, Inc. FOR FURTHER INFORMATION: U.S. MediaSam Brown, Inc.Christy CurranPhone +1-615-414-8668christycurran@sambrown.comO.U.S. MediaRudi Michelson Phone +61 (0)3 9620 3333 Mobile +61 (0)411 402 737 rudim@monsoon.com.auInvestorsWestwicke PartnersCaroline CornerPhone +1-415-202-5678 caroline.corner@westwicke.com
22 Jan, 2021
AVITA Medical, Inc. (RCEL) has moved higher as of late, but there could definitely be trouble on the horizon for this company.
12 Jan, 2021
VALENCIA, Calif. and MELBOURNE, Australia, Jan. 12, 2021 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, today announced preliminary unaudited estimates of its top line results for the three months ended December 31, 2020. Preliminary Fiscal Second Quarter Estimates * U.S based RECELL® revenue is expected to be $5.0 million in the second quarter of 2021 ended December 31, 2020, compared to $5.0 million in the previous quarter. U.S based RECELL revenue increased $1.9 million or 62% over the same quarter in the prior year. * Total global revenue is expected to be $5.1 million in the second quarter of 2021, compared to $5.1 million in the previous quarter. Total global revenue increased $1.8 million in the current quarter or 57% over the same quarter in the prior year. * The Company had cash of approximately $59.8 million, a decrease of $6.0 million or 9% over the $65.8 million held at the end of the previous quarter. Commercial Metrics: * Enrolled 9 additional patients in the pivotal study assessing the use of the RECELL System to treat stable vitiligo. * Added 7 new accounts in the second quarter 2021 for a total of 93 accounts. * Estimated procedural volumes were 485 in the second quarter of 2021, compared to 496 in the previous quarter. “I’m pleased with our team’s commercial execution during these challenging times,” said Dr. Mike Perry, AVITA Medical Chief Executive Officer. “We continue to make solid progress on our pipeline initiatives, and I look forward to updating you further during our quarterly earnings call.”The Company is providing the above information in advance of its participation in the 39th Annual J.P. Morgan Health Conference, which begins on Monday, January 11, 2021. The Company will post its conference presentation to the ASX Market Announcements Platform and will also make that presentation available on its website at www.avitamedical.com/investors.Authorized for release by the Chief Executive Officer of AVITA Medical, Inc.Financial Measures and other ItemsThe foregoing information and estimates are preliminary in nature and are subject to revisions as we prepare our Form 10-Q Quarterly Report for the second quarter ended December 31, 2020. Because we have not completed our normal quarterly closing and review procedures for the six months ended December 31, 2020, and subsequent events may occur that require material adjustments to these results, the final results and other disclosures for the period may differ materially from these estimates. These estimates should not be viewed as a substitute for the full disclosure of our Form 10-Q Quarterly Report. These estimated results should be read together with subsequent filings and announcements, including any subsequent press release announcing the Company’s earnings for the second quarter ended December 31, 2020.Non-U.S. GAAP Financial Measures and Other ItemsWe use the following measures of financial performance which are not presented in accordance with U.S. GAAP: * “U.S. based RECELL Sales”, which is the amount of revenue denominated in United States dollars, we generate from our commercial efforts in relation to the sale of RECELL Systems within the United states. Management believes that this measurement is useful for comparing period to period sales performance, and product acceptance of the Company’s lead product, the RECELL System, within the United States burn market. U.S. base RECELL Sales is a non-GAAP financial measure used by management in evaluating sales performance, and product acceptance, within the United States and for the purposes of making strategic decisions. Management believes that the presentation of U.S. base RECELL sales provides useful information to investors regarding our revenue results because they assist both investors and management in analyzing and benchmarking the performance and value of our business. U.S. RECELL Sales provides indicators of product performance that are not affected by currency fluctuations. Accordingly, management believes that this measurement is useful for comparing general sales performance from period to period in the Company’s largest market.ABOUT AVITA MEDICAL, INC. AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical’s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a RES® REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.AVITA Medical’s first U.S. product, the RECELL® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin™ Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 10,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL® Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions.In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe. To learn more, visit www.avitamedical.com.CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This letter includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this letter include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward- looking statement contained in this letter is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the company’s control. Investors should not place considerable reliance on the forward-looking statements contained in this letter. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this letter speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements. This press release was authorized by the review committee of AVITA Medical, Inc.  FOR FURTHER INFORMATION: U.S. Media Sam Brown, Inc. Christy Curran Phone +1-615-414-8668 christycurran@sambrown.com O.U.S. Media Rudi Michelson Phone +61 (0)3 9620 3333 Mobile +61 (0)411 402 737 rudim@monsoon.com.auInvestors Westwicke Partners Caroline Corner Phone +1-415-202-5678 caroline.corner@westwicke.com
28 Dec, 2020
VALENCIA, Calif. and MELBOURNE, Australia, Dec. 28, 2020 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today that management will present at the J.P. Morgan 39th Annual Healthcare Conference on Thursday, January 14, 2021 at 11:40 a.m. Eastern Time. A live, audio-only webcast of the presentation may be accessed by visiting ir.avitamedical.com. A replay of the webcast will be available shortly after the conclusion of the presentation and will be archived on AVITA Medical’s website for 30 days following the presentation.Authorized for release by the Chief Executive Officer of AVITA Medical, Inc.ABOUT AVITA MEDICAL, INC. AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical’s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a RES® REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.AVITA Medical’s first U.S. product, the RECELL® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin™ Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 10,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL® Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions.In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe. To learn more, visit www.avitamedical.com.CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This letter includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this letter include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward- looking statement contained in this letter is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the company’s control. Investors should not place considerable reliance on the forward-looking statements contained in this letter. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this letter speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements. This press release was authorized by the review committee of AVITA Medical, Inc. FOR FURTHER INFORMATION: U.S. Media Sam Brown, Inc. Christy Curran Phone +1-615-414-8668 christycurran@sambrown.com O.U.S. Media Rudi Michelson Phone +61 (0)3 9620 3333 Mobile +61 (0)411 402 737 rudim@monsoon.com.auInvestors Westwicke Partners Caroline Corner Phone +1-415-202-5678 caroline.corner@westwicke.com
15 Dec, 2020
Abstracts Highlighting Clinical and Health Economic Data Reinforce Effectiveness of Treatment with RECELL SystemMore than 10,000 Patients treated with RECELL System globallyVALENCIA, Calif. and MELBOURNE, Australia, Dec. 15, 2020 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today the presentation of RECELL® System data recently presented at the Northeast Regional Burn Conference and Southern Regional Burn Conference of the American Burn Association.“Since the U.S. Food and Drug Administration approval of the RECELL System in September 2018, 93 U.S. burn centers have ordered the RECELL System, with more than 80% of burn surgeons throughout the United States certified on the use of the system. There have now been more than 10,000 patients treated globally, with U.S. RECELL System sales topping $27 million in the two years since FDA approval,” said Dr. Mike Perry, AVITA Medical’s Chief Executive Officer. “As burn surgeons continue to gain experience with the RECELL System and increasingly use it across a range of burn sizes, we are encouraged to see the utility, positive clinical outcomes, and health economic benefits of the RECELL System highlighted at medical conferences. We remain committed to advancing burn care in collaboration with burn surgeons and look forward to expanding the benefit of the RECELL System to additional indications, including soft tissue defects and vitiligo, amongst others.”Recent RECELL® System Data Abstracts: * Carney.  A Pilot Study of Negative Pressure Therapy with Autologous Skin Cell Suspensions in a Porcine Model. Presented at Northeast Region Burn Conference; 2020 November 6; Virtual. * Chihade. Autologous Epidermal Skin Cell Suspension: A Cost-Effective Treatment for Burns >20% TBSA in a County Hospital with Limited Resources.  Southern Region Burn Conference; 2020 December 6; Virtual. * Desai. Aesthetic superiority of autologous cell suspension device in treating deep partial and full thickness burn compared to skin graft in a single case. Southern Region Burn Conference; 2020 December 6; Virtual. The RECELL System is FDA-approved for the treatment of acute thermal burns in patients 18 years and older. Used by a trained healthcare professional at the point of care, the RECELL System is used to prepare Spray-On Skin™ Cells to be sprayed directly on second-degree burn injuries or applied in combination with meshed autografts for third-degree burn injuries. The pivotal studies leading to the RECELL System’s FDA premarket approval for the treatment of acute thermal burns demonstrated that the RECELL System treated burns using 97.5i percent less donor skin when used alone in second-degree burns, and 32 percent less donor skin when used with autograft for third-degree burns.ii This statistically significant reduction in donor skin required to treat burn patients with the RECELL System produced healing comparable to the standard of care while providing a significant reduction in donor site pain and improved donor site healing.i For more information about the RECELL System, please visit www.RECELLSystem.com.ABOUT AVITA MEDICAL, INC. AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical’s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a RES® REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.AVITA Medical’s first U.S. product, the RECELL® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin™ Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 10,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL® Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions.In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe. To learn more, visit www.avitamedical.com.CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This letter includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this letter include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward- looking statement contained in this letter is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the company’s control. Investors should not place considerable reliance on the forward-looking statements contained in this letter. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this letter speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements. This press release was authorized by the review committee of AVITA Medical Limited. FOR FURTHER INFORMATION: U.S. Media Sam Brown, Inc. Christy Curran Phone +1-615-414-8668 christycurran@sambrown.com O.U.S. Media Rudi Michelson Phone +61 (0)3 9620 3333 Mobile +61 (0)411 402 737 rudim@monsoon.com.auInvestors Westwicke Partners Caroline Corner Phone +1-415-202-5678 caroline.corner@westwicke.com ________________________ i Holmes JH, Molnar JA, Carter JE, et al. A comparative study of the RECELL® device and autologous split-thickness meshed skin graft in the treatment of acute burn injuries. J Burn Care Res. 2018 ii Holmes JH, Molnar JA, Shupp JW, et al. Demonstration of the safety and effectiveness of the RECELL System combined with split-thickness meshed autografts for the reduction of donor skin to treat mixed-depth burn injuries. Burns. 2019;45:772-782
01 Dec, 2020
VALENCIA, Calif, and MELBOURNE, Australia, Dec. 01, 2020 (GLOBE NEWSWIRE) -- AVITA Therapeutics, Inc. (NASDAQ: RCEL, ASX:AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today the appointment of Kathy McGee as Chief Operating Officer, effective December 1, 2020. “Kathy’s extensive healthcare experience and industry insight are a welcome addition to AVITA’s leadership team,” said Dr. Mike Perry, AVITA Therapeutics’ Chief Executive Officer. “In particular her broad operational experience within Regenerative Medicine will be critically important as we seek to bring our pipeline products through development and into the markets.”Ms. McGee joins AVITA with over 25 years of biopharmaceutical and life sciences experience, most recently serving as President of CnA Consulting Group, which focuses on providing specialized consulting services to the life sciences industry. Prior to CnA Consulting, Ms. McGee was the Vice President of West Coast Operations at Shire Pharmaceuticals Regenerative Medicine Division, formerly Advanced BioHealing, where she was a part of the leadership team responsible for manufacturing operations, strategic planning, capital expansion, and real estate. At Advanced BioHealing, Ms. McGee served as the Senior Vice President of Operations and General Manager, with responsibility for the company’s manufacturing operations in La Jolla, CA. She has also held senior Operations leadership roles at Smith and Nephew and Advanced Tissue Sciences. She earned her Bachelor of Science in chemistry and mathematics from University College Galway Ireland, and holds a Master’s degree in Business and Management from Webster University.Authorized for release by the Chief Executive Officer of AVITA Therapeutics, Inc.ABOUT AVITA THERAPEUTICS, INC. AVITA Therapeutics is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Therapeutics’ patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a RES® REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.AVITA Therapeutics’ first U.S. product, the RECELL® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin™ Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 8,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL® Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions.In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe. To learn more, visit www.avitamedical.com.CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This letter includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this letter include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward- looking statement contained in this letter is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the company’s control. Investors should not place considerable reliance on the forward-looking statements contained in this letter. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this letter speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.FOR FURTHER INFORMATION: U.S. Media Sam Brown, Inc. Christy Curran Phone +1 615 414 8668 christycurran@sambrown.com O.U.S Media Monsoon Communications Rudi Michelson Phone +61 (0)3 9620 3333 Mobile +61 (0)411 402 737 rudim@monsoon.com.au Investors: Westwicke Partners Caroline Corner Phone +1 415 202 5678 caroline.corner@westwicke.com
30 Nov, 2020
In this article we will check out the progression of hedge fund sentiment towards Avita Medical Limited (NASDAQ:RCEL) and determine whether it is a good investment right now. We at Insider Monkey like to examine what billionaires and hedge funds think of a company before spending days of research on it. Given their 2 and […]