subslover
12 months ago
Aziyo Biologics and LeMaitre Vascular Partner for the Distribution of Aziyo’s Cardiovascular Portfolio
SILVER SPRING, Md., April 20, 2023 (GLOBE NEWSWIRE) -- Aziyo Biologics, Inc. (Nasdaq: AZYO) (“Aziyo”), a company that develops and commercializes biologic products to improve compatibility between medical devices and the patients who need them, today announced it has entered into a distribution agreement with LeMaitre Vascular, Inc. (Nasdaq: LMAT) (“LeMaitre”), a provider of vascular devices, implants and services. Under the agreement terms, Aziyo will grant LeMaitre exclusive U.S. distribution rights for the products within its cardiovascular segment: ProxiCor® PC, ProxiCor® CTR, Tyke® and VasCure®.
“We are thrilled to collaborate with LeMaitre, an established leader in the vascular space, to distribute our cardiovascular surgery products,” said Dr. Randy Mills, President and Chief Executive Officer of Aziyo. “Our products are designed to be highly efficacious across a wide range of applications, and we look forward to expanding their availability by leveraging LeMaitre’s much larger commercial organization. This partnership should increase our operational efficiency as we focus our commercial resources behind our CanGaroo Envelope, which is utilized to help reduce complications associated with implantable electronic devices such as pacemakers, defibrillators and neuromodulation devices.”
Aziyo’s cardiovascular products are based on an extracellular matrix derived from porcine small intestine submucosa, which has been shown to modulate biologic healing response and reduce inflammation in a range of surgical applications. The products include: Proxicor® PC, used for pericardial closure; ProxiCor® CTR, used for cardiac tissue repair; Tyke®, the only extracellular matrix cleared for neonatal and infant patch, pledget and intracardiac repair; and VasCure® for vascular repair. The term of the collaboration is three years, and LeMaitre will have the exclusive option to acquire the product line following the first year or under certain other circumstances.
David Roberts, LeMaitre’s President, commented, “We are pleased to be partnering with Aziyo to add these next-generation products to our U.S. product offering and to provide our vascular and cardiac surgeons an extracellular option in addition to our existing range of biologic patches.”
About Aziyo Biologics
Aziyo develops and commercializes biologic products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Aziyo’s mission is to humanize medical devices to improve patient outcomes. For more information, visit www.Aziyo.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements and information concerning the effectiveness of our products, the ability to expand availability of our products or increase our operational efficiency as a result of our distribution arrangement with LeMaitre, and the potential success of our distribution arrangement with LeMaitre. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect our business, strategy, operations or financial performance, and actual results may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, and other important factors that may cause actual results, performance or achievements to differ materially from those contemplated or implied in this press release, including, but not limited to, risks regarding the ability to successfully execute or realize the anticipated benefits under our distribution arrangement with LeMaitre; our inability to generate sufficient revenue to achieve or sustain profitability; adverse changes in economic conditions and instability and disruption of credit markets; our ability to continue as a going concern; our products and our ability to enhance, expand, develop and commercialize its product offerings; the impact on our business of the recall of a single lot of our FiberCel product and the discontinuation of its sales by our distribution partner; our dependence on our commercial partners; physician awareness of the distinctive characteristics, and acceptance by the medical community, of our products; the ability to obtain regulatory approval or other marketing authorizations; and our intellectual property rights, and other important factors which can be found in the “Risk Factors” section of Aziyo’s public filings with the Securities and Exchange Commission (“SEC”), including Aziyo’s Annual Report on Form 10-K for the year ended December 31, 2022, as such factors may be updated from time to time in Aziyo’s other filings with the SEC, including, Aziyo’s Qu
subslover
12 months ago
Aziyo Biologics and LeMaitre Vascular Partner for the Distribution of Aziyo’s Cardiovascular Portfolio
SILVER SPRING, Md., April 20, 2023 (GLOBE NEWSWIRE) -- Aziyo Biologics, Inc. (Nasdaq: AZYO) (“Aziyo”), a company that develops and commercializes biologic products to improve compatibility between medical devices and the patients who need them, today announced it has entered into a distribution agreement with LeMaitre Vascular, Inc. (Nasdaq: LMAT) (“LeMaitre”), a provider of vascular devices, implants and services. Under the agreement terms, Aziyo will grant LeMaitre exclusive U.S. distribution rights for the products within its cardiovascular segment: ProxiCor® PC, ProxiCor® CTR, Tyke® and VasCure®.
“We are thrilled to collaborate with LeMaitre, an established leader in the vascular space, to distribute our cardiovascular surgery products,” said Dr. Randy Mills, President and Chief Executive Officer of Aziyo. “Our products are designed to be highly efficacious across a wide range of applications, and we look forward to expanding their availability by leveraging LeMaitre’s much larger commercial organization. This partnership should increase our operational efficiency as we focus our commercial resources behind our CanGaroo Envelope, which is utilized to help reduce complications associated with implantable electronic devices such as pacemakers, defibrillators and neuromodulation devices.”
Aziyo’s cardiovascular products are based on an extracellular matrix derived from porcine small intestine submucosa, which has been shown to modulate biologic healing response and reduce inflammation in a range of surgical applications. The products include: Proxicor® PC, used for pericardial closure; ProxiCor® CTR, used for cardiac tissue repair; Tyke®, the only extracellular matrix cleared for neonatal and infant patch, pledget and intracardiac repair; and VasCure® for vascular repair. The term of the collaboration is three years, and LeMaitre will have the exclusive option to acquire the product line following the first year or under certain other circumstances.
David Roberts, LeMaitre’s President, commented, “We are pleased to be partnering with Aziyo to add these next-generation products to our U.S. product offering and to provide our vascular and cardiac surgeons an extracellular option in addition to our existing range of biologic patches.”
About Aziyo Biologics
Aziyo develops and commercializes biologic products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Aziyo’s mission is to humanize medical devices to improve patient outcomes. For more information, visit www.Aziyo.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements and information concerning the effectiveness of our products, the ability to expand availability of our products or increase our operational efficiency as a result of our distribution arrangement with LeMaitre, and the potential success of our distribution arrangement with LeMaitre. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect our business, strategy, operations or financial performance, and actual results may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, and other important factors that may cause actual results, performance or achievements to differ materially from those contemplated or implied in this press release, including, but not limited to, risks regarding the ability to successfully execute or realize the anticipated benefits under our distribution arrangement with LeMaitre; our inability to generate sufficient revenue to achieve or sustain profitability; adverse changes in economic conditions and instability and disruption of credit markets; our ability to continue as a going concern; our products and our ability to enhance, expand, develop and commercialize its product offerings; the impact on our business of the recall of a single lot of our FiberCel product and the discontinuation of its sales by our distribution partner; our dependence on our commercial partners; physician awareness of the distinctive characteristics, and acceptance by the medical community, of our products; the ability to obtain regulatory approval or other marketing authorizations; and our intellectual property rights, and other important factors which can be found in the “Risk Factors” section of Aziyo’s public filings with the Securities and Exchange Commission (“SEC”), including Aziyo’s Annual Report on Form 10-K for the year ended December 31, 2022, as such factors may be updated from time to time in Aziyo’s other filings with the SEC, including, Aziyo’s Qu
Golden Cross
12 months ago
Business Highlights:
~ Reported $49.2 million of net sales for full year 2022
~ Fourth quarter 2022 net sales of $12.7 million, representing an increase of 17% in Q4 2022 compared to Q4 2021
~ Continued strong growth in sales of CanGaroo® and SimpliDerm® which, on an aggregate basis, increased 30% in Q4 2022 compared to Q4 2021
Improved gross margin 8 percentage points to 39% in Q4 2022 compared to Q4 2021
Entered into a U.S. distribution agreement with Sientra for the sale of SimpliDerm
“We are pleased to have closed the year with record revenues and thrilled to have helped more than 50,000 patients with our products in 2022,” said Dr. Randy Mills, President and Chief Executive Officer of Aziyo Biologics. “We believe we are on a path for continued growth in key markets where there remains significant unmet need. We are excited about our long-term potential and the opportunity to accelerate growth and enhance efficiency through strategic partnerships, as evidenced by the distribution agreement with Sientra for SimpliDerm announced earlier today.
“At the same time, following the recent feedback from the FDA delaying the market clearance of our CanGaroo RM Antibacterial Envelope, we recognize the need to extend our cash runway and have implemented significant measures to eliminate or defer expenses as we transition to a more capital efficient business model,” continued Dr. Mills. “Nevertheless, we remain committed to our CanGaroo RM development program and are confident we will be able to address the FDA’s outstanding questions.”
Fourth Quarter 2022 Financial Results
Net sales for the fourth quarter of 2022 were $12.7 million, an increase of 17% compared to the fourth quarter of 2021. This growth was led by CanGaroo and SimpliDerm, which on an aggregate basis, grew by 30% in the fourth quarter of 2022, compared to the fourth quarter of 2021.
Gross profit for the fourth quarter of 2022 was $5.0 million and gross margin was 39%, as compared to $3.4 million and 31%, respectively, in the corresponding prior-year period. Gross margin, excluding intangible asset amortization (a measure not presented in accordance with U.S. generally accepted accounting principles (“GAAP”)) was 46% for the fourth quarter of 2022, as compared to 39% in the fourth quarter of 2021. The increase in gross margin was primarily due to efficiency improvements in the Company’s Orthobiologics and Women’s Health business units.
Total operating expenses were $13.8 million for the fourth quarter of 2022, as compared to $11.2 million in the corresponding prior-year period, representing an increase of 24%. The increase was primarily due to legal expenses and updated estimates of contingent liabilities in excess of currently available insurance coverage related to the 2021 recall of a single donor lot of the Company’s FiberCel Viable Bone Matrix (“FiberCel”). Increased sales and marketing also contributed to higher operating expenses, partially offset by a decrease in research and development.
Operating results for the fourth quarter of 2022 included $5.0 million of other income related to a reduction of the Company’s revenue interest obligation, which is based on the forecasted timing and extent of net sales for the Company’s CanGaroo and cardiovascular product lines and the associated royalty and milestone payments. The Company’s revenue interest obligation terminates in May 2027.
Net loss was $5.4 million in the fourth quarter of 2022, as compared to $9.1 million in the corresponding period of the prior year. Net loss per share in the fourth quarter of 2022 was $0.38 per share, compared to a loss of $0.82 per share in the fourth quarter of 2021.
Aziyo’s cash balance as of December 31, 2022 was $17.0 million, which included $10.2 million in net proceeds from the follow-on public offering completed in December 2022 and additional borrowings of $4.0 million under an existing term loan facility.
Full Year 2022 Financial Results
Net sales for the full year 2022 were $49.2 million, an increase of 4% compared to the full year 2021 net sales of $47.4 million. Excluding 2021 sales of $4.9 million from the discontinued product, FiberCel, net sales from current products increased 16% in the full year 2022 compared to the prior year.
Gross profit for the full year 2022 was $19.2 million and gross margin was 39%, as compared to $19.0 million and 40%, respectively, in the prior year. Gross margin, excluding intangible asset amortization (a non-GAAP financial measure) was 46% for the full year 2022, as compared to 47% in the full year 2021.
Total operating expenses were $51.0 million for the full year 2022, as compared to $42.1 million in the prior year, representing an increase of 21%. The increase was primarily due to higher expenses related to litigation, general and administrative and sales and marketing expenses.
Net loss was $32.9 million in the full year 2022, as compared to $24.8 million in the prior year. Loss per share in the full year 2022 was $2.38 per share, unchanged from the prior year.
Golden Cross
12 months ago
$AZYO Aziyo Biologics News AH's
Aziyo Biologics and LeMaitre Vascular Partner for the Distribution of Aziyo’s Cardiovascular Portfolio
April 20, 2023 16:30 ET
SILVER SPRING, Md., April 20, 2023 (GLOBE NEWSWIRE) -- Aziyo Biologics, Inc. (Nasdaq: AZYO) (“Aziyo”), a company that develops and commercializes biologic products to improve compatibility between medical devices and the patients who need them, today announced it has entered into a distribution agreement with LeMaitre Vascular, Inc. (Nasdaq: LMAT) (“LeMaitre”), a provider of vascular devices, implants and services. Under the agreement terms, Aziyo will grant LeMaitre exclusive U.S. distribution rights for the products within its cardiovascular segment: ProxiCor® PC, ProxiCor® CTR, Tyke® and VasCure®.
“We are thrilled to collaborate with LeMaitre, an established leader in the vascular space, to distribute our cardiovascular surgery products,” said Dr. Randy Mills, President and Chief Executive Officer of Aziyo. “Our products are designed to be highly efficacious across a wide range of applications, and we look forward to expanding their availability by leveraging LeMaitre’s much larger commercial organization. This partnership should increase our operational efficiency as we focus our commercial resources behind our CanGaroo Envelope, which is utilized to help reduce complications associated with implantable electronic devices such as pacemakers, defibrillators and neuromodulation devices.”
Aziyo’s cardiovascular products are based on an extracellular matrix derived from porcine small intestine submucosa, which has been shown to modulate biologic healing response and reduce inflammation in a range of surgical applications. The products include: Proxicor® PC, used for pericardial closure; ProxiCor® CTR, used for cardiac tissue repair; Tyke®, the only extracellular matrix cleared for neonatal and infant patch, pledget and intracardiac repair; and VasCure® for vascular repair. The term of the collaboration is three years, and LeMaitre will have the exclusive option to acquire the product line following the first year or under certain other circumstances.
David Roberts, LeMaitre’s President, commented, “We are pleased to be partnering with Aziyo to add these next-generation products to our U.S. product offering and to provide our vascular and cardiac surgeons an extracellular option in addition to our existing range of biologic patches.”
About Aziyo Biologics
Aziyo develops and commercializes biologic products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Aziyo’s mission is to humanize medical devices to improve patient outcomes. For more information, visit www.Aziyo.com.
https://www.globenewswire.com/news-release/2023/04/20/2651600/0/en/Aziyo-Biologics-and-LeMaitre-Vascular-Partner-for-the-Distribution-of-Aziyo-s-Cardiovascular-Portfolio.html
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