midastouch017
10月前
COLLPLANT BIOTECHNOLOGIES REPORTS 2023 FULL YEAR FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE
https://finance.yahoo.com/news/collplant-biotechnologies-reports-2023-full-110000475.html
Regenerative breast implant program large-animal study underway to evaluate commercial-size implants with topline data expected in Q4
Ends 2023 with $26.7 million in cash and cash equivalents
Conference call to be held on Thursday, April 4, 2024 at 10:00 a.m. U.S. EDT
REHOVOT, Israel, April 4, 2024 /PRNewswire/ -- CollPlant Biotechnologies (Nasdaq: CLGN), a regenerative and aesthetics medicine company developing innovative technologies and products based on its non-animal-derived recombinant human collagen (rhCollagen) for tissue regeneration and organ manufacturing, today announced financial results for the full year ended December 31, 2023 and provided a corporate update.
"During 2023, the end of which became a challenging year for our nation, we excelled in the advancement of our key programs," said CollPlant's Chief Executive Officer, Yehiel Tal. "We leveraged our pioneering collagen technology platform and dynamic workforce to strengthen existing business collaborations, and advanced our programs - notably with partner, AbbVie. We progressed the dermal filler candidate, which is now in clinical development, and formed a collaboration with industrial 3D printing leader, Stratasys, to refine the manufacturing scale for our breast implants program. Related to our dermal filler partnership with AbbVie, we achieved an important milestone triggering a $10 million milestone payment that we realized in June 2023."
Mr. Tal continued, "As we begin 2024, we believe we are poised to take advantage of the aesthetic and regenerative market this year with a strong balance sheet, lean operating structure, and support from our partners."
2023 and Recent Corporate Highlights
Collaboration Updates
During 2023, CollPlant made significant progress with its development partner, AbbVie, to advance the dermal and soft tissue filler program toward commercialization.
In June 2023, CollPlant announced the achievement of an important milestone under the AbbVie collaboration which triggered a $10 million payment from AbbVie to CollPlant. Per CollPlant's agreement with AbbVie, CollPlant has the potential to receive additional milestones and option product payments, as well as meaningful royalties on product sales.
In April 2023, CollPlant announced a joint development and commercialization agreement with Stratasys Ltd. to collaborate on the development of a solution to bio-fabricate human tissues and organs using Stratasys' P3 technology-based bioprinter and CollPlant's rhCollagen-based bioinks. The first project under the agreement focuses on the development of a bioprinter specific to the creation of CollPlant's regenerative breast implants. It is meant to be an industrial-scale production solution for CollPlant's regenerative breast implants program. CollPlant's state-of-the-art breast implants are being developed to regenerate an individual's natural breast tissue without eliciting immune response, providing a potentially revolutionary alternative for both aesthetic and reconstructive procedures. Under the agreement, both companies have agreed to cross-promote each other's bioprinting products.
CollPlant remains engaged in partnering discussions with several industry leaders in order to leverage its rhCollagen technology and expertise in 3D bioprinting with the mission to develop novel regenerative medical and aesthetics solutions and related applications.
Regenerative Breast Implants
Our regenerative breast implants are targeting the $2.9 billion global breast implant market. The most common breast augmentation or reconstruction procedures today are based on synthetic silicone breast implantations, an artificial substitution for natural regenerated tissue with risks of complications.
Currently, there are no commercial products that allow regeneration of soft tissues such as the breast. In the U.S. alone, hundreds of thousands of people per year experience adverse events that range from autoimmune symptoms to the very serious breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). CollPlant's rhCollagen-based, 3D-bioprinted breast implants that are comprised of CollPlant's proprietary plant-derived rhCollagen and other biomaterials, are expected to regenerate breast tissue without eliciting immune response, and therefore may provide a revolutionary alternative for aesthetic and reconstructive procedures, including postmastectomy for cancer patients.
In addition, CollPlant's regenerative breast implants can be a novel solution for women in the breast reconstruction and augmentation market, which is sizeable, as it is the second most common plastic surgery procedure that is performed worldwide today.
In January 2023, CollPlant announced the successful completion of a large-animal study for its regenerative breast implants. This preclinical study demonstrated progressive stages of tissue regeneration after three months, as highlighted by the formation of maturing connective tissue and neovascular networks within the implants, with no adverse events reported. This study was followed by additional large-animal studies that were intended to further optimize the implant design and composition. New tissue formation and neovascularization with no adverse tissue reactions were demonstrated confirming previous results.
In December of 2023, CollPlant initiated a large-animal study to evaluate commercial-size, 3D-bioprinted, regenerative breast implants. This study will be used to obtain data that will be used to support subsequent human studies and future product commercialization. CollPlant expects to report topline data from this study in the fourth quarter of this year.
Intellectual Property
In November 2023, CollPlant announced that the U.S. Patent and Trademark Office granted the Company a patent that relates to its photocuring technology and serves as the basis of its photocurable dermal filler product candidate, being developed for the aesthetics market.
In addition, in March 2024, the same patent application received allowance in Brazil. Patents were also granted in Israel and Australia allowing for protection until 2039 in these regions.
This newly issued patent is related to CollPlant's photocuring technology within its photocurable dermal filler product candidate and represents an integral part of the Company's strategy to expand the uses for its novel, rhCollagen technology into new, high-value markets.
Gut-on-a-Chip Tissue Model
Given CollPlant's focus on the medical aesthetics area and its collaboration with AbbVie, it has decided to place its resources on hold directed toward its gut-on-a-chip program for the treatment of ulcerative colitis. The Company highly values this program, and the rationale for this relates to the extensive projected timing to progress the tissue model as it relates to cell collection, as well as other processes that must first be conducted before even beginning testing. Therefore, in line with prioritizing its resources, CollPlant expects to reinitiate this program once its resources are commensurate with the projected timing of this program.
Corporate Governance
In the second quarter of 2023, CollPlant announced that it hired a dedicated expert to lead its Environment, Social and Governance (ESG) effort. CollPlant plans to file its first ESG report in the second quarter which will outline its ESG objectives.
In September 2023, CollPlant announced that it joined the United Nations Global Compact, the world's largest initiative for sustainable and responsible corporate governance. As a new participant of this voluntary leadership platform, CollPlant strengthens its commitment to operate sustainably.
Year-Ended December 31, 2023 Financial Results
GAAP revenues for the year ended December 31, 2023, were $11.0 million and included mainly revenues from AbbVie, CollPlant's business partner. Revenues increased by $10.7 million, compared to $299,000 for the year ended December 31, 2022. The increase is mainly related to the achievement of a milestone under the AbbVie Agreement, which triggered a $10.0 million payment and a $600,000 increase in sales of rhCollagen products.
GAAP cost of revenues for the year ended December 31, 2023, was $2.0 million, compared to $400,000 for the year ended December 31, 2022. The increase in cost of revenues by approximately $1.6 million is mainly due to: (i) approximately $320,000 in royalty expenses to the IIA, mainly relating to the milestone achievement under the AbbVie Agreement, (ii) approximately $711,000 related to bioinks, VergenixFG, and rhCollagen sales, and (iii) approximately $570,000 related to inventory write offs.
GAAP gross profit for the year ended December 31, 2023, was $9.0 million, compared to gross loss of $101,000 for the year ended December 31, 2022.
GAAP operating expenses for the year ended December 31, 2023, were $16.5 million, compared to $17.0 million, for the year ended December 31, 2022. The decrease of $500,000 is mainly attributed to a decrease of $745,000 in general and administrative expenses, mainly comprised of: (i) a decrease of $224,000 in employees' salaries expense, (ii) a decrease of $364,000 in share-based compensation expenses and (iii) income of $140,000 for insurance indemnification, offset by an increase of $229,000 in research and development expenses. On a non-GAAP basis, the operating expenses for the year ended December 31, 2023 were $14.5 million, compared to $15.2 million in the year ended December 31, 2022. Non-GAAP measures exclude certain non-cash expenses.
GAAP financial income, net, for the year ended December 31, 2023, totaled $493,000, compared to $172,000 in the year ended December 31, 2022. The increase in financial income, net, is due to the increase in interest rates and interest received from the Company's short-term cash deposits.
GAAP net loss for the year ended December 31, 2023 was $7.0 million, or $0.62 basic loss per share, compared to a net loss of $16.9 million, or $1.53 basic loss per share, for the year ended December 31, 2022. Non-GAAP net loss for the year ended December 31, 2023, was $5.2 million, or $0.46 basic loss per share, compared to $15.2 million loss, or $1.37 basic loss per share, for the year ended December 31, 2022.
Balance Sheets and Cash Flow
The Company's cash and cash equivalents balance as of December 31, 2023, was $26.7 million.
Cash used in operating activities was $2.8 million during the year ended December 31, 2023, compared to $13.7 million for the year ended December 31, 2022. Cash used during the year ended December 31, 2023 includes the $10 million milestone payment from AbbVie.
Net cash used in investing activities was $1.2 million during the year ended December 31, 2023 compared to $28.9 million in net cash that was provided by investing activities during the year ended December 31, 2022. The decrease is mainly attributed to repayment and investment in short-term cash deposits during the year ended December 31, 2022.
Cash provided by financing activities was $1.1 million for the year ended December 31, 2023 compared to $1.9 million in the year ended December 31, 2022. Cash provided by financing activities is attributed to proceeds from the exercise of warrants and options into shares.
Conference call information
To participate in the conference call, please use the dial-in information below:
U.S. investors: 1-877-407-9716
Investors outside of the U.S.: 1-201-493-6779
Israel investors: 1-809-406-247
Conference ID: 13744114
Note, you can avoid long wait times for the operator by using the Call me™ feature and clicking the link below 15 minutes prior to the scheduled call start time:
https://callme.viavid.com/viavid/?callme=true&passcode=13728588&h=true&info=company&r=true&B=6
Webcast information
A live webcast will also be available in listen-only mode and can be accessed here or via the link to be posted on the News & Events section of the CollPlant Investor relations website. A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the Company's website for a limited time.
Submit questions to management in advance of the call and webcast
To ask management a question ahead of the call, please email Dan Ferry at LifeSci Advisors LLC up until 24 hours before the event at daniel@lifesciadvisors.com.
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
December 31,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$
26,674
$
29,653
Restricted deposit
241
23
Trade receivables, net
-
9
Other accounts receivable and prepaid expenses
393
543
Inventories
714
1,430
Total current assets
28,022
31,658
Non-current assets:
Restricted deposit
57
188
Operating lease right-of-use assets
3,070
2,711
Property and equipment, net
2,789
2,966
Intangible assets, net
188
245
Total non-current assets
6,104
6,110
Total assets
$
34,126
$
37,768
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share data)
December 31,
2023
2022
Liabilities and shareholders' equity
Current liabilities:
Trade payables
$
980
$
1,133
Operating lease liabilities
624
529
Accrued liabilities and other payables
1,647
1,443
Total current liabilities
3,251
3,105
Non-current liabilities:
Operating lease liabilities
2,535
2,382
Total non-current liabilities
2,535
2,382
Total liabilities
5,786
5,487
Commitments and contingencies
Shareholders' Equity:
Ordinary shares, NIS 1.5 par value - authorized: 30,000,000 ordinary shares
as of December 31, 2023 and , 2022; issued and outstanding: 11,452,672
and 11,186,481 ordinary shares as of December 31, 2023 and 2022,
respectively
4,982
4,873
Additional paid in capital
121,068
118,099
Accumulated other comprehensive loss
(969)
(969)
Accumulated deficit
(96,741)
(89,722)
Total shareholders' equity
28,340
32,281
Total liabilities and shareholders' equity
$
34,126
$
37,768
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
Year ended December 31,
2023
2022
2021
Revenues
$
10,959
$
299
$
15,641
Cost of revenues
1,991
400
2,005
Gross profit (loss)
8,968
(101)
13,636
Operating expenses:
Research and development
10,484
10,255
7,631
General, administrative and marketing
5,996
6,741
5,940
Total operating income (loss)
(7,512)
(17,097)
65
Financial income, net
493
172
172
Net income (loss)
$
(7,019)
$
(16,925)
$
237
Basic net income (loss) per ordinary share
$
(0.62)
$
(1.53)
$
0.02
Diluted net income (loss) per ordinary share
$
(0.62)
$
(1.53)
$
0.02
Weighted average number of ordinary shares used in
computation of basic net income (loss) per share
11,389,168
11,033,310
9,968,972
Weighted average number of ordinary shares used in
computation of diluted net income (loss) per share
11,389,168
11,033,310
11,966,788
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands)
Year ended December 31,
2023
2022
2021
Cash flows from operating activities:
Net income (loss)
$
(7,019)
$
(16,925)
$
237
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
Loss on sale of property and equipment
18
-
-
Depreciation and amortization
1,102
1,076
773
Accrued interest
(28)
(87)
(151)
Share-based compensation to employees and consultants
1,937
2,174
1,597
Exchange differences on cash and cash equivalents
379
608
(143)
Remeasurement of Derivatives liability
-
-
(28)
Changes in assets and liabilities:
Decrease in trade receivables
9
261
560
Decrease (increase) in inventories
749
(312)
181
Decrease (increase) in other receivables and prepaid expenses
150
(119)
(185)
Decrease in operating lease right-of-use assets
527
461
400
Increase (decrease) in trade payables
(153)
99
236
Decrease in operating lease liabilities
(638)
(916)
(337)
Increase (decrease) in accrued liabilities and other payables
204
14
(464)
Decrease in deferred revenues
-
(32)
(175)
Net cash provided by (used in) operating activities
(2,763)
(13,698)
2,501
Cash flows from investing activities:
Capitalization of intangible assets
-
(42)
(161)
Purchase of property and equipment
(954)
(1,274)
(1,428)
Proceed from short term deposit
-
50,238
-
Investment in restricted deposits
(270)
-
-
Investment in deposits
-
(20,000)
(30,000)
Proceeds from sale of property and equipment
68
-
33
Net cash provided by (used in) investing activities
(1,156)
28,922
(31,556)
Cash flows from financing activities:
Proceeds from issuance of shares and warrants less issuance expenses
-
-
32,743
Exercise of options and warrants into shares
1,108
1,874
6,017
Net cash provided by financing activities
1,108
1,874
38,760
Effect of exchange rate changes on cash and cash equivalents and restricted deposits
(379)
(608)
143
Net increase (decrease) in cash and cash equivalents and restricted deposits
(3,190)
16,490
9,848
Cash and cash equivalents and restricted cash at the beginning of the year
29,864
13,374
3,526
Cash and cash equivalents and restricted deposits at the end of the year
$
26,674
$
29,864
$
13,374
COLLPLANT BIOTECHNOLOGIES LTD.
APPENDICES TO CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands)
Year ended December 31,
2023
2022
2021
Supplemental discloser of non-cash activities:
Right of use assets recognized with corresponding lease liabilities
$
886
$
219
$
557
Classification of issuance costs liability to equity
$
-
$
-
$
50
Capitalization of Share-based compensation to inventory
$
33
$
37
$
-
Supplemental discloser of cash activities:
Cash paid during the year for taxes
$
8
$
31
$
-
Reconciliation of cash, cash equivalents and restricted cash at the end of the year
Cash and cash equivalents
$
26,674
$
29,653
$
13,148
Restricted deposits short term
-
23
13
Restricted deposits long term
-
188
213
Total cash and cash equivalents and restricted deposits
$
26,674
$
29,864
$
13,374
CollPlant Biotechnologies Ltd.
Reconciliation of GAAP to Non-GAAP Financial Measures
(U.S. dollars in thousands, except per share data)
Year ended December 31,
2023
2022
GAAP operating expenses:
$
16,480
$
16,996
Change of operating lease accounts
-
455
Share-based compensation to employees, directors and consultants
(1,937)
(2,211)
Non-GAAP operating expenses:
14,543
15,240
GAAP operating loss
(7,512)
(17,097)
Change of operating lease accounts
-
(455)
Share-based compensation to employees, directors and consultants
1,937
2,211
Non-GAAP operating loss
(5,575)
(15,341)
GAAP Net loss
(7,019)
(16,925)
Change of operating lease accounts
(111)
(455)
Share-based compensation to employees, directors and consultants
1,937
2,211
Non-GAAP Net loss
$
(5,193)
$
(15,169)
GAAP basic and diluted loss per ordinary share
$
(0.62)
$
(1.53)
NON- GAAP basic and diluted loss per ordinary share
$
(0.46)
$
(1.37)
About CollPlant
CollPlant is a regenerative and aesthetic medicine company focused on 3D bioprinting of tissues and organs, and medical aesthetics. The Company's products are based on its rhCollagen (recombinant human collagen) produced with CollPlant's proprietary plant based genetic engineering technology. These products address indications for the diverse fields of tissue repair, aesthetics, and organ manufacturing, and are ushering in a new era in regenerative and aesthetic medicine.
In 2021 CollPlant entered into a development and global commercialization agreement for dermal and soft tissue fillers with Allergan, an AbbVie company, the global leader in the dermal filler market.
For more information about CollPlant, visit http://www.collplant.com.
Use of Non-US GAAP ("non-GAAP")
Financial results for 2023 and 2022 are presented on both a GAAP and a non-GAAP basis. GAAP results were prepared in accordance with U.S. GAAP and include all revenue and expenses recognized during the period. The release contains certain non-GAAP financial measures for operating costs and expenses, operating income (or loss), net income (or loss) and basic and diluted net income (or loss) per share that exclude the effects of non-cash expense for share-based compensation to employees, directors and consultants, and change in operating lease accounts. CollPlant's management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the Company's performance that enhances management's and investors' ability to evaluate the Company's operating costs, net income (or loss) and income (or loss) per share, and to compare them to historical Company results.
The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP. Management uses both GAAP and non-GAAP measures when operating and evaluating the Company's business internally and therefore decided to make these non-GAAP adjustments available to investors. The non-GAAP financial measures used by the Company in this press release may be different from the measures used by other companies.
For more information on the non-GAAP financial measures, please see the "Reconciliation of GAAP to Non-GAAP Financial Measures" later in this release. This accompanying table has more details on the GAAP financial measures that are most directly comparable to non-GAAP financial measures and the related reconciliations between these financial measures.
The Company's consolidated financial statements for the year ended December 31, 2023, are presented in accordance with generally accepted accounting principles in the U.S.
A copy of the Company's annual report on Form 20-F for the year ended December 31, 2023 has been filed with the U.S. Securities and Exchange Commission at www.sec.gov and posted on the Company's investor relations website at http://ir.collplant.com/. The Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request to CollPlant Investor Relations at 4 Oppenheimer, Weizmann Science Park, Rehovot 767104, Israel or by phone at +972-73-232 5600.
midastouch017
1年前
CollPlant Biotechnologies Announces Second Quarter Financial Results For 2023 with Revenues of $10.2 Million
https://finance.yahoo.com/news/collplant-biotechnologies-announces-second-quarter-110000369.html
Received in July 2023, $10 million from partner, AbbVie, for achieving a major milestone in the second quarter, for the clinical-phase dermal filler product in accordance with the strategic collaboration agreement
Entered into collaboration with Stratasys, a world-leading 3D printing company, with initial focus on the development of a bioprinting solution for the fabrication of CollPlant's regenerative breast implants
Readying breast implant study in large animals for initiation by year end
Continued positive sales trajectory for 3D bioinks
Cash and cash equivalents totaled $22.3 million as of June 30, 2023; cash runway extended with additional $10 million milestone payment received in July 2023 from AbbVie
Revenues of $10.6 million and operating income of $5.7 million for the first six months of 2023
Conference call to be held on August 24, 2023 at 10:00 am U.S. ET; Dial-in information herein
REHOVOT, Israel, Aug. 24, 2023 /PRNewswire/ -- CollPlant Biotechnologies (NASDAQ: CLGN), a regenerative and aesthetics medicine company developing innovative technologies and products based on its non-animal-derived collagen for tissue regeneration and organ manufacturing, today announced financial results for the second quarter ended June 30, 2023, and provided a corporate update on its programs.
CollPlant achieved a milestone related to its dermal filler program in collaboration with AbbVie, which triggered a related milestone payment in the second quarter of 2023.
CollPlant achieved a milestone related to its dermal filler program in collaboration with AbbVie, which triggered a related milestone payment in the second quarter of 2023.
"This quarter, we were very pleased to announce the achievement of an important milestone related to the dermal filler product developed in collaboration with our partner, AbbVie, for which we received a $10 million payment. We also announced a joint development and commercialization agreement with Stratasys, a world-leader in additive manufacturing that will initially focus on developing a bioprinting solution for the fabrication of our regenerative breast implants in development. Both collaborations are expected to allow us to continue our momentum towards reaching important upcoming milestones related to these programs, with the former providing a vehicle to maintain our strong cash position," said CollPlant's Chief Executive Officer, Yehiel Tal.
Mr. Tal continued, "One of our upcoming milestones will be initiating by the end of this year a second large-animal study to evaluate our regenerative breast implants. We have already established the trial infrastructure and look forward to providing an update as soon as we conclude this study."
Q2 and recent corporate highlights
Program development
CollPlant is planning to initiate a second large-animal study to evaluate commercial sized 3D bioprinted regenerative breast implants, by year end. This study follows the completion of the first large-animal study, the results of which were announced in January of this year. The first study demonstrated progressive stages of tissue regeneration after three months, as highlighted by the formation of maturing connective tissue and neovascular networks within the implants, with no adverse events reported.
In the U.S. alone, hundreds of thousands of people per year experience adverse events that range from autoimmune symptoms to the very serious breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). CollPlant's breast implants that are comprised of CollPlant's proprietary plant-derived rhCollagen and other biomaterials, are expected to regenerate breast tissue without eliciting immune response, and thus may provide a revolutionary alternative for aesthetic and reconstructive procedures, including postmastectomy for cancer patients.
Collaboration updates
In June, CollPlant announced the achievement of a milestone with respect to the clinical phase dermal filler product, which is under its collaboration agreement with AbbVie. According to the agreement, the achievement of this milestone triggered a $10 million payment from AbbVie to CollPlant. CollPlant has the potential to receive additional milestone payments as well as future royalties in accordance with its long-term collaboration with AbbVie for the dermal filler product.
In April, CollPlant announced a joint development and commercialization agreement with Stratasys to collaborate on the development of a printing solution to bio-fabrication of human tissues and organs using Stratasys' P3 technology-based bioprinter and CollPlant's rh-Collagen-based bioinks. The bioprinting solution is being designed to enable the production of scaffolds that will accurately mimic the physical properties of human tissues and organs. These scaffolds are to meet the product specification including resolution and reproducibility. The combined proprietary technologies are expected to enable the fabrication of tissues and organs that also possess differentiated regenerative properties. The first project focuses on the development of an industrial-scale solution for CollPlant's regenerative breast implants program. Under the agreement, both companies have also agreed to cross-promote each other's bioprinting products.
CollPlant is developing, together with Tel Aviv University and Sheba Medical Center, a system that enhances the physiological relevance of the human gut to provide a predictive personalized platform. CollPlant mimics the gut structure by 3D printing the gut tissue geometry in high resolution using its unique rhCollagen-based bioink formulation. This tissue model is to be used for evaluating therapy response in patients suffering from ulcerative colitis. Recently, the CollPlant team managed to successfully grow epithelial cells on the 3D printed scaffolds that mimic the gut tissue geometry. The Company expects to be able to provide an update on next steps for this program by the end of this year.
CollPlant remains engaged in partnering dialogs with several industry leaders and academic institutions interested in the Company's rhCollagen technology and expertise in 3D bioprinting to develop therapeutics and medical applications.
Commercial portfolio of bioink solutions
CollPlant's bioink platform is intended to enable its customers to streamline the process of new product development while also accelerating timelines and reducing overall costs. CollPlant's new bioink, Collink.3D-50L is the first bioink available in powder form which provides enhanced operational specificity and flexibility for the end-user because of its mechanical properties to address additional printing requirements of soft and hard tissues. These features of CollPlant's new bioink enable the end user to address a wide range of 3D bioprinting applications, including drug discovery, drug screening and tissue testing, as well as the development of transplantable tissues and organs.
Operational updates
In line with CollPlant's mission to build a company that operates and works towards solutions that support a sustainable environment, CollPlant recently recruited a dedicated manager to analyze, formulate and execute upon the set of standards for its Environmental, Social and Governance (ESG) program. This initiative is designed to help CollPlant meet the evolving standards applicable to publicly listed companies in the U.S., as well as help business partners and socially conscious investors better understand CollPlant's alignment with sustainable values – both operationally and as a component of its overall company mission.
Second quarter ended June 30, 2023 financial results
GAAP revenues for the second quarter ended June 30, 2023 were $10.2 million, an increase of $10.1 million compared to $66,000 in the second quarter ended June 30, 2022. The increase in revenues was mainly related to the achievement of a milestone with respect to the AbbVie agreement, which triggered a $10 million payment.
GAAP cost of revenues for the second quarter ended June 30, 2023, was $615,000, an increase of $572,000 compared to $43,000 in the second quarter ended June 30, 2022. Cost of revenue mainly includes the cost of the Company's rhCollagen based products, and royalties to the Israeli Innovation Authority (IIA) for our sales. The increase in cost of revenues in the amount of approximately $572,000 is mainly comprised of: (i) $305,000 in royalty expenses to the IIA mainly related to the milestone payment received from AbbVie, and (ii) $171,000 relating to the BioInk, VergenixFG, and rhCollagen sales.
GAAP gross profit for the second quarter ended June 30, 2023 was $9.6 million, compared to gross profit of $23,000 in the second quarter ended June 30, 2022.
GAAP operating expenses for the second quarter ended June 30, 2023 were $3.9 million, compared to $4.2 million in the second quarter ended June 30, 2022. The decrease of $300,000 is mainly related to general and administrative expenses and comprised of (i) $223,000 in employees' salaries expense including a decrease in accrued vacation liability and alterations in employment contractual terms implemented in 2022, and (ii) $194,000 share-based compensation expenses mainly related to a directors grant in May 2022, offset by an increase of approximately $116,000 in professional services expenses and patents expenses. On a non-GAAP basis, operating expenses for the second quarter ended June 30, 2023 were $3.6 million, compared to $3.9 million in the second quarter ended June 30, 2022. Non-GAAP measures exclude certain non-cash expenses.
GAAP financial income, net, for the second quarter ended June 30, 2023 totaled $85,000, compared to financial expenses, net, of $100,000 in the second quarter of 2022. The increase in financial income is due to interest received from our short-term cash deposits and exchange rate differences.
GAAP net income for the second quarter ended June 30, 2023 was $5.8 million, or $0.51 basic income per share, compared to a net loss of $4.3 million, or $0.39 basic loss per share, for the second quarter ended June 30, 2022. Non-GAAP net income for the second quarter ended June 30, 2023 was $6.0 million, or $0.53 income per share, compared to a net loss of $4.0 million, or $0.36 basic loss per share, for the second quarter ended June 30, 2022.
Cash and cash equivalents as of June 30, 2023, were $22.3 million.
Cash used in operating activities during the three months ended June 30, 2023 was $3.8 million, compared to $4.0 million cash used in operating activities during the three months ended June 30, 2022.
Cash used in investing activities during the three months ended June 30, 2023 and during the three months ended June 30, 2022 was $337,000.
Cash provided by financing activities during the three months ended June 30, 2023 was $89,000. During the three months ended June 30, 2022, there was no cash provided by financing activities.
Year-to-date (six-month) period ended June 30, 2023 financial results
GAAP revenues for the six months ended June 30, 2023, were $10.6 million and included mainly revenues from the AbbVie Agreement as well as income from sales of the Company's BioInk and rhCollagen. Revenues increased by $10.5 million, compared to $132,000 in the six months ended June 30, 2022. The increase is related almost entirely to the achievement of a milestone under the AbbVie Agreement and $500,000 increase in sales of rhCollagen.
GAAP cost of revenues for the six months ended June 30, 2023, was $940,000, an increase of $866,000 compared to $74,000 in the six months ended June 30, 2022. The increase in cost of revenues in the amount of approximately $866,000 is mainly comprised of: (i) $316,000 in royalty expenses to the IIA mainly related to the milestone payment received from AbbVie, and (ii) $424,000 relating to the sales of BioInk, VergenixFG, and rhCollagen.
GAAP gross profit for the six months ended June 30, 2023, was $9.7 million, compared to gross profit of $58,000 in the six months ended June 30, 2022.
GAAP operating expenses for the six months ended June 30, 2023, were $7.5 million, compared to $8.0 million, in the six months ended June 30, 2022. The decrease of $500,000 in expenses is mainly related to general and administrative expenses and comprised of: (i) $278,000 in employees' salaries expense including a decrease in accrued vacation liability and alterations in employment contractual terms implemented in 2022, and (ii) $124,000 share-based compensation expenses mainly related to options granted in 2022. On a non-GAAP basis, the operating expenses for the six months ended June 30, 2023 were $6.7 million, compared to $7.4 million in the six months ended June 30, 2022. Non-GAAP measures exclude certain non-cash expenses.
GAAP financial expenses, net for the six months ended June 30, 2023, totaled $111,000, compared to $192,000 in the six months ended June 30, 2022. The decrease in financial expenses, net, is due to interest received from the Company's short-term cash deposits.
GAAP net income for the six months ended June 30, 2023 was $2.0 million, or $0.18 basic income per share, compared to a net loss of $8.1 million, or $0.74 basic loss per share, for the six months ended June 30, 2022. Non-GAAP net income for the six months ended June 30, 2023, was $2.7 million, or $0.24 basic loss per share, compared to $7.5 million loss, or $0.69 basic loss per share, for the six months ended June 30, 2022.
Cash used in operating activities during the six months ended June 30, 2023 and June 30, 2022, remain unchanged at $7.2 million.
Cash used in investing activities during the six months ended June 30, 2023 was $541,000, compared to $29.5 million cash provided by investing activities during the six months ended June 30, 2022. The decrease is mainly attributed to repayment and investment in short term cash deposits during the six months ended June 30, 2022.
Cash provided by financing activities during the six months ended June 30, 2023 was $892,000, compared to cash provided by financing activities of $1.5 million during the six months ended June 30, 2022. Cash provided by financing activities is attributed to proceeds from the exercise of options and warrants into shares.
Conference call information
CollPlant will hold a conference call to discuss its second quarter 2023 financial results along with corporate updates on August 24, 2023 at 10 am ET.
To participate in the conference call, please use the dial-in information below:
U.S. investors: 1-877-407-9716
Investors outside of the U.S.: 1-201-493-6779
Israel investors: 1-809-406-247
Conference ID: 13739191
Note, you can avoid long wait times for the operator by using the Call me™ feature and clicking the link below 15 minutes prior to the scheduled call start time:
https://callme.viavid.com/viavid/?callme=true&passcode=13728588&h=true&info=company&r=true&B=6
Submit questions to management in advance of the call
To ask management a question ahead of the call, please email John Mullaly at LifeSci Advisors LLC up until 24 hours before the event at jmullaly@lifesciadvisors.com.
midastouch017
2年前
CollPlant Achieves Milestone and To Receive $10 Million From AbbVie in Accordance with its Regenerative Dermal Filler Product Collaboration Agreement
https://finance.yahoo.com/news/collplant-achieves-milestone-receive-10-110000013.html
REHOVOT, Israel, June 26, 2023 /PRNewswire/ -- CollPlant Biotechnologies (NASDAQ: CLGN), a regenerative and aesthetics medicine company developing innovative technologies and products based on its non-animal-derived collagen for tissue regeneration and organ manufacturing, today announced the achievement of a milestone with respect to the clinical phase dermal filler product, according to its agreement with AbbVie for the development of a regenerative dermal and soft tissue filler product. According to the agreement, the achievement of this milestone triggers a $10 million payment from AbbVie to CollPlant.
In 2021, CollPlant and AbbVie entered into an exclusive worldwide development and commercialization agreement for dermal and soft tissue filler products for the medical aesthetics market, using CollPlant's recombinant human collagen (rhCollagen) technology.
CollPlant has granted AbbVie a worldwide exclusive license to use its rhCollagen technology in combination with AbbVie's proprietary technologies, for the production and commercialization of dermal and soft tissue fillers.
Yehiel Tal, Chief Executive Officer of CollPlant, stated, "We are very pleased with the significant progress made with the dermal filler program and the achievement of this milestone. The collaboration with AbbVie provides us with the opportunity to co-develop what could be the first aesthetic product utilizing our rhCollagen with a worldwide leader in biopharmaceutical health. CollPlant's rhCollagen is non-immunogenic and non-allergenic, and enables tissue regeneration. Hence, we believe that the regenerative dermal filler under development could create a paradigm shift in the medical aesthetics field."
Mr. Tal continued, "This achievement further validates CollPlant's technology as the 'gold-standard' collagen for regenerative and aesthetic medicine. We are extremely excited to have advanced this program to address a market estimated at $5.5 billion in annual sales, with a projected 10% compounded annual growth rate. We look forward to continuing a highly productive partnership as we drive the program towards potential commercialization."
In 2021, CollPlant received an upfront payment of $14 million in accordance with the terms of the agreement. In addition to the $10 million current milestone payment, CollPlant is also eligible to receive up to an additional $26 million in milestone payments for the dermal filler product, as well as royalty payments and a fee for the manufacture and supply of rhCollagen.
About CollPlant
CollPlant is a regenerative and aesthetic medicine company focused on the 3D bioprinting of tissues and organs, as well as medical aesthetics. The Company's products are based on its rhCollagen (recombinant human collagen) produced with CollPlant's proprietary plant-based genetic engineering technology. These products address indications within the diverse fields of tissue repair, aesthetics, and organ manufacturing. CollPlant's mission is to pioneer a new era in regenerative and aesthetic medicine.
In 2021, CollPlant entered into a development and global commercialization agreement for dermal and soft tissue fillers with Allergan, an AbbVie company, the global leader in the dermal filler market.
For more information, visit http://www.collplant.com.
Forward-Looking Statements
This press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to CollPlant's objectives plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that CollPlant intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate.
Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause CollPlant's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the Company's history of significant losses, its need to raise additional capital and its inability to obtain additional capital on acceptable terms, or at all; the Company's expectations regarding the timing and cost of commencing clinical trials with respect to tissues and organs which are based on its rhCollagen based BioInk and products for medical aesthetics; the Company's ability to obtain favorable pre-clinical and clinical trial results; regulatory action with respect to rhCollagen based BioInk and medical aesthetics products including but not limited to acceptance of an application for marketing authorization review and approval of such application, and, if approved, the scope of the approved indication and labeling; commercial success and market acceptance of the Company's rhCollagen based products, in 3D Bioprinting and medical aesthetics, including the regenerative dermal filler co-developed with AbbVie; the Company's ability to establish sales and marketing capabilities or enter into agreements with third parties and its reliance on third party distributors and resellers; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations and the achievement of milestones and other terms and conditions under such partnerships and collaborations, including the achievement of further milestones and payments under CollPlant's collaboration with AbbVie with respect to the regenerative dermal filler and other future products; the Company's reliance on third parties to conduct some or all aspects of its product manufacturing; the scope of protection the Company is able to establish and maintain for intellectual property rights and the Company's ability to operate its business without infringing the intellectual property rights of others; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; the impact of competition and new technologies; general market, political, and economic conditions in the countries in which the Company operates; projected capital expenditures and liquidity; changes in the Company's strategy; and litigation and regulatory proceedings. More detailed information about the risks and uncertainties affecting CollPlant is contained under the heading "Risk Factors" included in CollPlant's most recent annual report on Form 20-F filed with the SEC, and in other filings that CollPlant has made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect CollPlant's current views with respect to future events, and CollPlant does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts
CollPlant:
Eran Rotem
Deputy CEO & CFO
Tel: + 972-73-2325600
Eran@collplant.com
Investors:
LifeSci Advisors
John Mullaly
jmullaly@lifesciadvisors.com
Photo: https://mma.prnewswire.com/media/2140258/CollPlant_Dermal_Filler.jpg
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SOURCE CollPlant
Paullee
4年前
CollPlant Issues Letter to Shareholders
Download as PDFFEBRUARY 18, 2021 9:31AM EST
Expansion of collaboration with United Therapeutics to cover a second lifesaving organ, human kidneys, in addition to lungs
Development and commercialization agreement with Allergan Aesthetics, an AbbVie company, for rhCollagen to be used in dermal and soft tissue filler products
Growing revenues and strong cash position, allowing execution of our strategic plan
REHOVOT, Israel, Feb. 18, 2021 /PRNewswire/ -- CollPlant Biotechnologies (NASDAQ: CLGN) today announced the following letter from its Chief Executive Officer, Yehiel Tal, to its shareholders.
3D bioprinted trachea using CollPlant’s BioInk, courtesy of United Therapeutics and 3D systems
Dear shareholders,
What a year it has been – and how it has changed our way of life! All of us have been affected in some way by Covid-19. We are optimistic that we will soon be able to return to normal life.
Despite the difficulties arising from the pandemic, we advanced several activities in 2020 making it a transformational year for CollPlant Biotechnologies.
Our partnerships
During the past year, we fostered existing partnerships and created new ones with Tier One companies. These collaborations further validate CollPlant's technology as the gold standard in human collagen and the optimal building block for regenerative and aesthetic medicine.
2021 kicked off with the exciting news of CollPlant entering into a development and commercialization agreement with Allergan Aesthetics, an AbbVie company, for CollPlant's type I recombinant human collagen (rhCollagen) to be used in dermal and soft tissue filler products. Combining rhCollagen's superior properties with Allergan's propriety technologies, this collaboration is expected to create a paradigm shift in the medical aesthetic field by providing next-generation regenerative products with long lasting results.
We expanded our collaboration with United Therapeutics which exercised its option with CollPlant to cover a second lifesaving organ, human kidneys, in addition to lungs. This expanded collaboration aims to help reduce global organ shortages of kidney transplants and potentially save the lives of millions of patients on kidney waiting lists.
CollPlant and 3D Systems have recently established a platform for collaboration in the field of 3D bioprinting, bringing together CollPlant's expertise in rhCollagen-based BioInks and regenerative medicine, with 3D Systems' expertise in 3D printing and healthcare. The collaboration aims to jointly address an unmet market need for a comprehensive solution to produce tissues and scaffolds for regenerative medicine applications.
We entered into a supply agreement with STEMCELL Technologies, Canada's largest privately owned biotechnology company, for use of CollPlant's rhCollagen in a broad range of cell culture applications. The recently signed agreement follows the companies' established business relationship, which started in 2014 when STEMCELL began purchasing and incorporating CollPlant's rhCollagen into some of its cell culture expansion and differentiation media kits. To date, hundreds of companies, as well as research and academic institutes, have used these kits for research and development projects. Under the supply agreement, STEMCELL distributes the kits globally for use in the regenerative medicine research market. The cell culture market is just one example of the vast potential of our rhCollagen platform technology in life science applications that have the potential to enable breakthroughs that improve patients' lives.
Our product pipeline
Our R&D team continued accelerating development of all our major programs.
CollPlant develops a variety of BioInk formulations that are tissue and organ specific. These BioInks enable the printing of constructs that mimic the properties of the target tissues or organs to facilitate optimal regeneration. CollPlant's rhCollagen has superior properties such as bio-functionality, homogeneity, and safety, and therefore it is the ideal building block for tissue and organ transplants used in regenerative medicine. Furthermore, CollPlant established a bioprinting lab to develop 3D bioprinted products alone or under collaboration with partners.
Our development program for injectable and bioprinted regenerative breast implants is moving forward quickly. These implants are designed to gradually degrade and be replaced by newly grown natural breast tissue that is free of any foreign material. This program is currently in the pre-clinical phase. In addition, we are on track with the development of photocurable formulations which are based on rhCollagen and other ingredients for dermal/soft tissue filler products used in the medical aesthetics market. CollPlant granted AbbVie a right of first negotiation to obtain a worldwide exclusive license for the abovementioned injectable breast implant and for the photocurable dermal filler products.
In November 2020, we announced our development program for an antiviral agent for potential treatment of COVID-19 patients. In-vitro early results of our formulations based on our proprietary rhCollagen imbedded with silver nanoparticles (AgNP) showed significant inhibition of avian coronavirus infectivity. Further studies are ongoing to optimize the formulations and doses. We intend to develop an anti-viral inhalation formulation to limit the spread of coronavirus in the upper and lower respiratory systems. With the pandemic inflicting a high human and financial toll, an available treatment can benefit millions worldwide and allow rapid recovery of social and economic activity while reducing the probability for new waves of infection.
Our activities in consortiums and societies
We continue to increase and cultivate our participation and leadership in societies and organizations that are at the forefront of creating industry standards and advancing biofabrication technologies.
As a member of the Industry Relations Committee of ISBF (International Society for Biofabrication), a scientific and professional society promoting advancements in biofabrication, I hosted ISBF's virtual event held in January 2021. The event titled "Translation of laboratory discoveries into large scale manufacturing of tissues and organs" featured experts in the field from academia and industry, and attracted great interest and participation.
In January 2020, we partnered with the Advanced Regenerative Manufacturing Institute (ARMI), a consortium of over 150 partner organizations from industry, academia, and the U.S. federal government. ARMI's mission is to make practical the large-scale manufacturing of engineered tissues and tissue-related technologies. As members of the ARMI consortium, CollPlant contributes its expertise in BioInks for 3D bioprinting of tissues and organs.
As part of the ARMI activity, CollPlant is also a member of two of the industry's most respected and globally recognized technical standard development organizations - ASTM international, the American Society for Testing and Materials, and ASME, the American Society of Mechanical Engineers. Being a part of these committees enables us to contribute our expertise and knowhow in the development of industry standards for biofabrication, and positions CollPlant as a leading player in regenerative medicine.
We are concluding our 3rd year as a member at the ReMDO (RegenMed Development Organization) advanced biomanufacturing initiative, where we contribute to the development of a universal BioInk with tunable properties for 3D bioprinting of tissues and organs.
Our financials
CollPlant reports on a preliminary basis unaudited revenue of approximately $6 million for the year ended December 31, 2020, an increase of 160% compared to audited revenue of $2.3 million for the year ended December 31, 2019. Unaudited revenue for the year ended December 31, 2020 was derived mainly from sales of CollPlant's BioInk for the development of 3D bioprinting of human lungs, the exercise of an option by United Therapeutics for licensing CollPlant technology to print kidneys, and sales of rhCollagen to AbbVie for medical aesthetics product development. CollPlant has approximately $50 million of unaudited cash reserves and no debt as of the date hereof. Unaudited cash reserves include $14 million that Collplant expects to receive in February 2021 as an upfront payment from AbbVie as part of the recently entered into strategic agreement with AbbVie.
I am happy with the increase in revenue from our long-term collaborators, as well as from our cash position that gives us the ability to execute our strategic plan. The preliminary estimate of revenue for the year ended December 31, 2020 and the unaudited cash reserve and debt as of the date hereof are based on currently available information, are subject to change and may vary from actual results. Collpant is under no obligation to update the preliminary estimate of revenue for the year ended December 31, 2020 and the cash reserve and debt as of the date hereof for any subsequent changes or events.
In summary,
These are exciting times at CollPlant Biotechnologies. There is much to be proud of, and yet much more to do. We believe we have all it takes to become the leader in regenerative medicine, helping people live longer and better through our innovative collagen technology. My deep appreciation goes out to our employees for their dedication and commitment to the advancement of our activities throughout these challenging times. I thank the board of directors and all of our shareholders for your continued support. We greatly appreciate the trust you have placed in us and look forward to reporting our continuing progress during 2021.
Respectfully submitted,
Yehiel Tal,
Chief Executive Officer,
CollPlant Biotechnologies
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