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Protalix BioTherapeutics Reports Second Quarter 2023 Financial and Business Results
https://finance.yahoo.com/news/protalix-biotherapeutics-reports-second-quarter-105000780.html
Company to host conference call and webcast today at 8:30 a.m. EDT
CARMIEL, Israel, Aug. 7, 2023 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today reported financial results for the second quarter ended June 30, 2023 and provided a business update on recent regulatory, clinical and corporate developments.
"2023 has been a transformational year for Protalix thus far," said Dror Bashan, Protalix's President and Chief Executive Officer. "We are very proud to have received regulatory approval for Elfabrio® in both the United States and the European Union, a significant milestone for adult Fabry disease patients and their families alike. Our commercial partner, Chiesi Global Rare Diseases, has the expertise and global reach to maximize the potential of Elfabrio, and Chiesi has already launched the product in the United States. As the second approved drug from our proprietary platform, this approval not only validates our recombinant protein expression platform but also our strong clinical and regulatory expertise in rare diseases. We now turn our focus to strengthening our rare disease pipeline programs and building a sustainable portfolio. We extend our gratitude to our team and dedicated partners for their commitment to our programs and more importantly to patients in need."
2023 Second Quarter and Recent Business Highlights
Regulatory Advancements
The Company, together with its development and commercialization partner, Chiesi Global Rare Diseases (Chiesi), a business unit of the Chiesi Group, announced that Elfabrio® (pegunigalsidase alfa) received regulatory approval in both the United States (U.S.) and European Union (EU) for the treatment of adult patients with Fabry disease in the 1 mg\kg every two weeks dosage. Elfabrio, a PEGylated enzyme replacement therapy (ERT), is a recombinant human a–Galactosidase–A enzyme expressed in plant-cell culture that is designed to provide a long half-life.
On May 5, 2023, the European Commission (EC) granted marketing authorization to Elfabrio (pegunigalsidase alfa) in the European Union.
On May 10, 2023, the U.S. Food and Drug Administration (FDA) approved Elfabrio (pegunigalsidase alfa-iwxj) in the U.S. for the treatment of adult patients with Fabry disease.
Clinical Developments
The Company's First in Human (FIH) phase I clinical trial of PRX–115, a recombinant PEGylated uricase product candidate under development as a potential treatment for severe gout, continues to advance. To date, 16 patients have been dosed in the trial. The FIH trial is a double-blind, placebo-controlled, single ascending dose study designed to evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of PRX–115 in approximately 56 patients with elevated uric acid levels (>6.0 mg/dL) and no previous exposure to PEGylated uricase. The study is being conducted at New Zealand Clinical Research (NZCR) under the New Zealand Medicines and Medical Devices Safety Authority (MedSafe) and the Health and Disability Ethics Committee (HDEC) guidelines.
Corporate Developments
During the three months ended June 30, 2023, the Company announced that it is eligible to receive a $20 million milestone payment from Chiesi Global Rare Diseases. The milestone payment was triggered by the FDA's approval of Elfabrio for the treatment of adult patients with Fabry disease.
On June 26, 2023, the Company was included in the broad-market Russell 3000® Index at the conclusion of the 2023 Russell indexes annual reconstitution. Annual Russell indexes reconstitution captures the 4,000 largest US stocks as of April 28, 2023 ranked by total market capitalization. Membership in the US all-cap Russell 3000® Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000® Index or small-cap Russell 2000® Index as well as the appropriate growth and value style indexes.
On June 27, 2023, the Company hosted a key opinion leader (KOL) event highlighting the recent FDA approval of Elfabrio in the United States. The event featured presentations from Ankit Mehta, MD, FASN (Baylor University Medical Center), who discussed the opportunity for Elfabrio to address unmet needs in Fabry disease, and Giacomo Chiesi, Head of Chiesi Global Rare Diseases, who discussed Chiesi's commercial capabilities. Protalix leadership also provided insight into the Company's strategy and future plans. Access to a replay of the event is available at the following site: https://lifescievents.com/event/protalix/.
Second Quarter 2023 Financial Highlights
The Company recorded revenues from selling goods of $15.1 million during the three months ended June 30, 2023, an increase of $11.7 million, or 344%, compared to revenues of $3.4 million for the three months ended June 30, 2022. The increase resulted primarily from an increase of $11.7 million in sales to Chiesi, following the approvals by the FDA and the European Medicines Agency (EMA) of Elfabrio.
The Company recorded revenues from license and R&D services of $20.0 million for the three months ended June 30, 2023, an increase of $14.6 million, or 270%, compared to revenues of $5.4 million for the three months ended June 30, 2022. The increase resulted from the $20.0 million regulatory milestone payment from Chiesi in connection with the FDA approval of Elfabrio. Revenues from license and R&D services are comprised primarily of revenues we recognized in connection with the Chiesi Agreements.
Cost of goods sold was $6.1 million for the three months ended June 30, 2023 an increase of $2.0 million, or 49%, from cost of goods sold of $4.1 million for the three months ended June 30, 2022. The increase in cost of goods sold was primarily the result of the increase in sales of Elfabrio drug substance to Chiesi and royalties payable to the Israel Innovation Authority in connection with the Chiesi agreements.
For the three months ended June 30, 2023, the Company's total research and development expenses were approximately $4.5 million comprised of approximately $1.7 million in subcontractor-related expenses, approximately $2.0 million of salary and related expenses, approximately $0.1 million of materials-related expenses and approximately $0.7 million of other expenses. For the three months ended June 30, 2022, our total research and development expenses were approximately $7.6 million comprised of approximately $4.4 million in subcontractor-related expenses, approximately $1.6 million of salary and related expenses, approximately $0.7 million of materials-related expenses and approximately $0.9 million of other expenses. Total decrease in research and developments expenses was $3.1 million, or 41%, for the three months ended June 30, 2023 compared to the three months ended June 30, 2022. The decrease in research and development expenses primarily resulted from the completion of our Fabry clinical program and the regulatory processes related to the Biologics License Application (BLA) and Marketing Authorization Application (MAA) review of Elfabrio by the applicable regulatory agencies.
Selling, general and administrative expenses were $4.0 million for the three months ended June 30, 2023, an increase of $1.4 million, or 54%, compared to $2.6 million for the three months ended June 30, 2022. The increase resulted primarily from an increase of approximately $1.2 million in salary and related expenses due to one-time cash bonuses.
Financial expenses, net were $0.8 million for the three months ended June 30, 2023, compared to financial income, net of $0.2 million for the three months ended June 30, 2022. The increase resulted primarily from an increase of $0.6 million in costs related to exchange rates as well as an increase in our convertible notes related expenses of $0.3 million net of a gain recognized due to conversions of a portion of the 2024 Notes of $0.4 million.
In the three months ended June 30, 2023, the Company recorded income taxes of approximately $0.3 million which were primarily the result of the provision for current taxes in respect of Section 174 of the U.S. Tax Cuts and Jobs Act of 2017 which went into effect on January 1, 2022. Section 174 eliminated the option to immediately deduct research and development expenses in the year incurred and requires the Company to capitalize and amortize these expenditures over 15 years (for out of U.S.-based research and development). In addition, during the three months ended June 30, 2023, the Company released a valuation allowance related to deferred tax assets of the U.S. jurisdiction that resulted in a net benefit to tax expense of $3.1 million.
Cash and cash equivalents were approximately $48.2 million at June 30, 2023.
Net income for the three months ended June 30, 2023 was approximately $19.3 million, or $0.29 per share, basic, and $0.21 per share, diluted, compared to a net loss of $5.3 million, or $0.11 per share, basic and diluted, for the same period in 2022.
Conference Call and Webcast Information
The Company will host a conference call today, August 7, 2023 at 8:30 am EDT, to review the regulatory, clinical and corporate developments, which will also be available by webcast. To participate in the conference call, please dial the following numbers prior to the start of the call:
Conference Call Details:
Date: Monday, August 7, 2023
Time: 8:30 am EDT
Toll Free: 1-877-423-9813
International: 1-201-689-8573
Conference ID: 13740122
The Call me™ feature, which avoids having to wait for an operator, may be accessed at the following link: https://tinyurl.com/2v682k5m.
Webcast Details:
The conference will be webcast live from the Company's website and will be available via the following links:
Company Link: https://protalixbiotherapeutics.gcs-web.com/events0
Webcast Link: https://tinyurl.com/348f738e
Conference ID: 13740122
Participants are requested to access the websites at least 15 minutes ahead of the conference call to register, download and install any necessary audio software.
A replay of the call will be available for two weeks on the Events Calendar of the Investors section of the Company's website, at the above link.
About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. It is the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through a plant cell-based in suspension expression system. This unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa for the treatment of Gaucher disease, Protalix's first product manufactured through ProCellEx, excluding in Brazil, where Protalix retains full rights. Protalix's second product, Elfabrio®, was approved by both the FDA and the European Medicines Agency in May 2023. Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio.
Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: PRX-115, a plant cell-expressed recombinant PEGylated uricase for the treatment of severe gout; PRX-119, a plant cell-expressed long action DNase I for the treatment of NETs-related diseases; and others.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms "expect," "anticipate," "believe," "estimate," "project," "may," "plan," "will," "would," "should" and "intend," and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings for the clinical trial. Factors that might cause material differences include, among others: risks related to the commercialization of Elfabrio, our approved product for the treatment of adult patients with Fabry disease; risks relating to Elfabrio's market acceptance, competition, reimbursement and regulatory actions, including as a result of the boxed warning contained in the FDA approval received for the product; risks related to our commercialization partner's ability to obtain and maintain reimbursement for Elfabrio, and the extent to which patient assistance programs and co-pay programs are utilized; the likelihood that the FDA, EMA or other applicable health regulatory authorities will approve an alternative dosing regimen for Elfabrio; risks related to the regulatory approval and commercial success of our other product and product candidates, if approved; failure or delay in the commencement or completion of our preclinical studies and clinical trials, which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to satisfactorily demonstrate non-inferiority to approved therapies; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; inability to monitor patients adequately during or after treatment; and/or lack of sufficient funding to finance our clinical trials; delays in the approval or potential rejection of any applications we file with the FDA, EMA or other health regulatory authorities for our other product candidates, and other risks relating to the review process; risks associated with the novel coronavirus disease, or COVID-19, outbreak and variants, which may adversely impact our business, preclinical studies and clinical trials; risks associated with global conditions and developments such as supply chain challenges, the inflationary environment and tight labor market, and instability in the banking industry, which may adversely impact our business, operations and ability to raise additional financing if and as required and on terms acceptable to us; risks related to any transactions we may effect in the public or private equity markets to raise capital to finance future research and development activities, general and administrative expenses and working capital; risks relating to our evaluation and pursuit of strategic partnerships; the risk that the results of our clinical trials will not support the applicable claims of safety or efficacy and that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; risks relating to our ability to manage our relationship with our collaborators, distributors or partners, including, but not limited to, Pfizer and Chiesi; risks related to the amount and sufficiency of our cash and cash equivalents; risks relating to our ability to make scheduled payments of the principal of, to pay interest on or to refinance our outstanding notes or any other indebtedness; risks relating to the compliance by Fiocruz with its purchase obligations under our supply and technology transfer agreement, which may have a material adverse effect on us and may also result in the termination of such agreement; risk of significant lawsuits, including stockholder litigation, which is common in the life sciences sector; our dependence on performance by third-party providers of services and supplies, including without limitation, clinical trial services; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies; risks related to our supply of drug products to Pfizer; potential product liability risks, and risks of securing adequate levels of related insurance coverage; the possibility of infringing a third-party's patents or other intellectual property rights and the uncertainty of obtaining patents covering our products and processes and successfully enforcing our intellectual property rights against third-parties; risks relating to changes in healthcare laws, rules and regulations in the United States or elsewhere; the possible disruption of our operations due to terrorist activities and armed conflict, including as a result of the disruption of the operations of certain regulatory authorities and of certain of our suppliers, collaborative partners, licensees, clinical trial sites, distributors and customers; and other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law.
Investor Contact
Chuck Padala, Managing Director
LifeSci Advisors
646-627-8390
chuck@lifesciadvisors.com
PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
(Unaudited)
June 30, 2023
December 31, 2022
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
48,184
$
17,111
Short-term bank deposits
—
5,069
Accounts receivable – Trade
4,049
4,586
Other assets
1,708
1,310
Inventories
19,635
16,804
Total current assets
$
73,576
$
44,880
NON-CURRENT ASSETS:
Funds in respect of employee rights upon retirement
$
1,268
$
1,267
Property and equipment, net
4,637
4,553
Deferred income tax asset
3,130
—
Operating lease right of use assets
5,806
5,087
Total assets
$
88,417
$
55,787
LIABILITIES AND STOCKHOLDERS' EQUITY (NET OF CAPITAL
DEFICIENCY)
CURRENT LIABILITIES:
Accounts payable and accruals:
Trade
$
3,304
$
5,862
Other
18,545
12,271
Operating lease liabilities
1,260
1,118
Contracts liability
—
13,178
Total current liabilities
$
23,109
$
32,429
LONG TERM LIABILITIES:
Convertible notes
$
20,132
$
28,187
Liability for employee rights upon retirement
1,598
1,642
Operating lease liabilities
4,577
4,169
Total long term liabilities
$
26,307
$
33,998
Total liabilities
$
49,416
$
66,427
COMMITMENTS
STOCKHOLDERS' EQUITY (CAPITAL DEFICIENCY)
39,001
(10,640)
Total liabilities and stockholders' equity (net of capital deficiency)
$
88,417
$
55,787
PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
Six Months Ended
Three Months Ended
June 30, 2023
June 30, 2022
June 30, 2023
June 30, 2022
REVENUES FROM SELLING GOODS
$
20,141
$
12,410
$
15,075
$
3,382
REVENUES FROM LICENSE AND R&D SERVICES
24,522
12,428
20,000
5,371
TOTAL REVENUE
44,663
24,838
35,075
8,753
COST OF GOODS SOLD (1)
(9,233)
(10,121)
(6,148)
(4,087)
RESEARCH AND DEVELOPMENT EXPENSES (2)
(10,322)
(16,346)
(4,475)
(7,579)
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (3)
(7,146)
(5,765)
(4,031)
(2,611)
OPERATING INCOME (LOSS)
17,962
(7,394)
20,421
(5,524)
FINANCIAL EXPENSES
(2,169)
(1,242)
(1,305)
(623)
FINANCIAL INCOME
918
1,016
531
813
FINANCIAL INCOME (EXPENSES), NET
(1,251)
(226)
(774)
190
INCOME (LOSS) BEFORE TAXES ON INCOME
16,711
(7,620)
19,647
(5,334)
TAXES ON INCOME
(503)
-
(308)
-
NET INCOME (LOSS) FOR THE PERIOD
$
16,208
$
(7,620)
$
19,339
$
(5,334)
EARNINGS (LOSS) PER SHARE OF COMMON STOCK:
BASIC
$
0.26
$
(0.16)
$
0.29
$
(0.11)
DILUTED
$
0.18
$
(0.16)
$
0.21
$
(0.11)
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK
USED IN COMPUTING EARNINGS (LOSS) PER SHARE:
BASIC
62,378,745
46,589,976
67,158,628
47,327,952
DILUTED
78,896,220
46,589,976
83,200,641
47,327,952
(1) Includes share-based compensation
$
104
$
22
$
46
$
28
(2) Includes share-based compensation
$
324
$
161
$
144
$
85
(3) Includes share-based compensation
$
556
$
941
$
248
$
175
Logo - https://mma.prnewswire.com/media/999479/Protalix_Biotherapeutics_Logo.jpg
Cision
Cision
View original content:https://www.prnewswire.com/news-releases/protalix-biotherapeutics-reports-second-quarter-2023-financial-and-business-results-301894457.html
SOURCE Protalix BioTherapeutics, Inc.
I read it once (maybe a few times) on the stocktwits board. It was probably around a month ago. I have not heard it anywhere else.
Curious as to where you got wind of this "speculation" on the script numbers. I looked on some of the other message boards including ST and couldn't see anything being suggested.
I’ve heard the same figure. Anywhere from $200-300k annually.
Some insurance companies have added the drug to their approved coverage medications.
There is speculation that the company will give some script figures on the earnings call.
I've heard one patient is about 300K/year.
I do not know if this is true. If it is, then a 10 million estimate would be about 30 patients that switched to Elfabrio so far.
If anyone heard different, I would like to be corrected.
Protalix BioTherapeutics Q2 Earnings Preview
Aug. 04, 2023 1:17 PM ETProtalix BioTherapeutics, Inc. (PLX)
By: Arundhati Sarkar, SA News Editor
Protalix BioTherapeutics (NYSE:PLX) is scheduled to announce Q2 earnings results on Monday, August 7th, before market open.
The consensus EPS Estimate is -$0.04 and the consensus Revenue Estimate is $10.22M (+16.8% Y/Y).
Over the last 1 year, PLX has beaten EPS estimates 25% of the time and has beaten revenue estimates 100% of the time.
Protalix BioTherapeutics to Present at the Canaccord Genuity 43rd Annual Growth Conference
https://finance.yahoo.com/news/protalix-biotherapeutics-present-canaccord-genuity-105000240.html
CARMIEL, Israel, Aug. 1, 2023 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell–based protein expression system, today announced that Dror Bashan, the Company's President and Chief Executive Officer, will present on Wednesday, August 9, 2023 at 3:30 p.m. Eastern Daylight Time (EDT) at the Canaccord Genuity 43rd Annual Growth Conference. The conference is being held on August 7-10, 2023 at the InterContinental Boston Hotel, Boston, MA.
Mr. Bashan will provide a live corporate overview at the conference, and the Company's management will participate in one-on-one meetings on August 7-9 with investors who are registered to attend the conference. A live and archived webcast of Mr. Bashan's presentation will be available as follows:
Live Presentation and Webcast Details:
Wednesday, August 9, 2023 at 3:30 p.m. Eastern Daylight Time (EDT)
Webcast Registration and Link: https://tinyurl.com/ms7sy4hu
The webcast will be available for replay for at least two weeks on the Events Calendar of the Investors section of the Company's website, https://protalixbiotherapeutics.gcs-web.com/events0.
Protalix BioTherapeutics to Announce Second Quarter 2023 Financial and Business Results on August 7, 2023
https://finance.yahoo.com/news/protalix-biotherapeutics-announce-second-quarter-105000278.html
Company to host conference call and webcast at 8:30 a.m. EDT
CARMIEL, Israel, July 31, 2023 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell–based protein expression system, today announced that it will release its financial results for the second quarter ended June 30, 2023 and provide a business update on Monday, August 7, 2023.
Protalix Biotherapeutics Logo
Protalix Biotherapeutics Logo
Management will host a conference call with investors to discuss the financial results and provide an update on recent corporate and regulatory developments at 8:30 a.m. Eastern Daylight Time (EDT).
Conference Call Details:
Date: Monday, August 7, 2023
Time: 8:30 a.m. EDT
Toll Free: 1-877-423-9813
International: 1-201-689-8573
Conference ID: 13740122
The Call me™ feature, which avoids having to wait for an operator, may be accessed at the following link: https://tinyurl.com/2v682k5m.
Webcast Details
The conference will be webcast live from the Company's website and will be available via the following links:
Company Link: https://protalixbiotherapeutics.gcs-web.com/events0
Webcast Link: https://tinyurl.com/348f738e
Conference ID: 13740122
Participants are requested to access the call at least 15 minutes ahead of the conference to register, download and install any necessary audio software.
A replay of the call will be available for two weeks on the Events Calendar of the Investors section of the Company's website, at the above link.
Looks like frick and frack have been exposed LOL
They’ve already started
Any bets on when the next reverse split is required?
Holding well? LOL
They’re still dumping shares. The stock will continue to drop until this management is gone.
It is being sold now at a few phamacies. Hopefully it will be a while before they identify assets and need to issue the authorized shares.
Holding relatively well since the vote. Key is that it’s just AS. Won’t get the knee jerk reaction till they issue the shares.
Question is what comes first, share issuance or launch (sales/revenue) of elfabrio. We wait.
Down down down we go
More money for management. Less for shareholders. Just another day with PLX
I agree 100%
Since you decided to mention GMDA as a good comparison, I decided to take a look.
GMDA is down 81% in the past 5 years. It's down 16% in the past year alone. Is that supposed to be a sign of a successful business? LOL, this is becoming comical.
Dror's total compensation ($USD1.47M) is above average for companies of similar size in the US market ($USD762.26K).
https://simplywall.st/stocks/us/pharmaceuticals-biotech/nysemkt-plx/protalix-biotherapeutics/management
It’s also interesting that you make no mention of negative 70% ROI for shareholders. Hmm
Just FYI I don’t care if you reply or not.
Just FYI, as a general rule, this will be my last reply to you.
So, well let's see, Dror and Eyal did manage to bring in potentially billions of dollars worth of revenue by getting Elfabrio to the finish line. That is no easy feat. If you were in his shoes, would you not expect the same? Ps no need to answer that as per my first sentence here.
They are not desperate for funds, they are pivoting onto new things now that the product has been approved in USA and EU and essentially been handed to Chiesi to sell and with revenues already coming in from product sales (Giacomo Chiesi stated that Elfabrio product was already in the USA which means Chiesi has paid for that), and with the 20M milestone and with royalties to come soon. We know Elfabrio is listed already on almost all the biggest USA insurance companies and is moving through the EU, today we just got Italy confirmation too.
So no need to rest on your laurels, now time to reinvest current cash and new cash into new assets and grow the company in new ways. Sitting around while cash builds up is a nice thing to see in our bank account but it doesn't do anything for you. A new asset(s) will.
If management had not done what they had done in the past, PLX most likely would not exist today at all. I am confident of Elfabrio sales and that the company with Chiesi is going in increase SP nicely.
Note: After GMDA's FDA approval the company convened a special meeting of shareholders specifically to increase the A/S by 50% from 150 million to 225 million and no-one said a peep, in fact people said how great this was as GMDA could make some great deals afterwards, and praised the company and the CEO for being "so good" and "a rock star". Oh yeah and that was after doing a horrendous dilution of 20million shares (+17million warrants) when the OS was at about 80 million, thus a dilution of 25% of the OS. And the vote won with 26million For VS 3 million Against.
Oh yeah and the stock was trading higher for the next month.
Oh yeah and this massive dilution only gets them to "into 2024" as they don't yet have a partner. And more dilution if they don't have a partner inked in the next 3 months. Oh yeah and GMDA stated in their Q1 Earnings PR that the increase A/S was for the partnering as they need a partner and to pay of debt and raise money for operations hence plenty of dilution coming there. Again even moreso if no partner in the next 3-4 months. Oh and their product is only available in the USA.
Meanwhile PLX, Elfabrio is available in USA and EU simultaneously, they have a great partner in Chiesi, they already have cash to 2Q2025, already 1 more year than GMDA not including any new revenues and they want to improve the assets in the company given the high confidence in continued monies coming in. Well shock horror, what a terrible job they've done! So PLX wants to increase the A/S by 27% from 144 million to 184 million, (which is far less than what GMDA did in team of both level of increase and final A/S total), and the world caves in and people start asking for the CEO and CFO to get the chop, that they are greedy and selfish, "dirty pigs" etc and other same ridiculous things people say.
Management has waded through some very tough times and we are still here. The A/S increase is hardly too much nor untoward as evidenced above.
If you don't trust management then you shouldn't be invested in the company, it's just that simple.
Good luck on all future endeavours.
Why are emotions running high?
Here is a possible reason.
If you purchased shares 5 years ago you are now down over 70% from your investment. Meanwhile the management team continues to enrich themselves. For example Dror’s total comp last year was over $1.4M. Why is he making so much when investors have lost so much? And now he wants us all to allow him to dilute shareholders even more so he can continue to get rich at our expense. This is why there is a mass sell off.
If the company is still desperate for funds after obtaining multiple approvals for its flagship drug something is wrong. The details behind the milestone payments were never clear. Now we know why. The stock will continue to tumble as long as this management team is in place.
Why would I buy shares if I knew that? Duh
It’s all about this greedy management team. Dilute dilute dilute and then award yourselves endless free shares. Such a horrible management team is rare although not so rare for Israeli companies.
Hi Midas,
Only Friday's action I believe and be attributed to A/S emotions riding high.
In general though with regards the Market Cap and hence share price, I think this is the market looking at PLX as a show me the money situation.
Elfabrio is well and indeed approved in USA and EU, but the market may be looking at this taking into account the fact that Chiesi will be contending with Sanofi and Takeda. And while Elfabrio should be fine as clearly many of the current patients are not doing well on the current ERTs that Elfabrio ought very much to take good market share, but there isn't the proof yet, and the drug isn't launched yet.
Therefore I believe the market is waiting for proof of launch which really means sales can happen and then later to see the extent of those sales, before being truly confident that all will be well. Remember the market is highly averse to risk, especially I feel these days with the bear market we've been experiencing.
Let us note that PLX is not the only very recently approve product company to have the SP go down after approval. Recently Eyeniovia, Seres, Biomarin and Sarepta all are down since recent FDA approvals, and Seres is down despite a 125 million milestone payment from Nestle.
All these are in the same situation as PLX, people want to see if you can actual complete getting the product out and selling well.
I'm sure you will also not how despite RDHL having the best product in the world probably on H.Pylori, those sales have been slow on the uptake by general physicians (though it is the top prescribed branded product among gastroenterologist that are in the know).
This said the important difference with the RDHL situation is of course the fact that while h.pylori is common and physicians have many many products to choose from, that is not the case in Fabry, where Elfabrio is the only alternative ERT to Fabrazyme in the USA, but Elfabrio with definite better safety and probably better real world efficacy, and has shown in clinical trials to be better and Replagal in general. As well as this, the physicians are a small circle that all know each other and all know about Elfabrio, so sales should not be a problem at all.
Chiesi has really been a fantastic partner with 200 million already invested and probably another 100 million by the time launch is complete in USA and EU. They have every incentive to maximise sales too.
So that is my take on the market. And yes of course from our perspective PLX is worth far more than 135M market cap at the moment.
In fact, in addition to my post, it might be good to ask BooDog his/her thoughts, as he/she apparently is deciding to wait at the moment before getting in. So one might as BooDog, his/her rationales.
All the best,
Spidey
I like this. And I was with family so missed the dip....
"And just giving it a second to think about it, the increase of 40 million authorised shares is just prudent and responsible given the low 33 million count remaining they could be at. Nor does it mean that they will suddenly dump all the shares. "
That's exactly shorty trying to shake out the weak hands. This happens all the time and is an easy target for shorts to take advantage of. Exasperated by low volumes it's easy to bring on the volatility.
Anyway, I see this in a positive way and will be watching to add.
Excellent Spidey. You have convinced me,
the market however is not!
Is the market always right? probably not,
but after the double approval,
and still the sp is at $2.00 and struggling?
You think it is all about the the increase o
the authorised shares?
Why so Midas?
I really don't see the big deal here. As I just posted on ST, apologies my more crude verbiage in the ST post, seems to resonate better with some of the people there. One must adapt:
"So let me get this straight.
Nothing new happened yesterday & some of you just decided to buy into stupidity and fear and go awol?
The company wants to increase authorised shares by 40M as after all potential warrants are conversion (that we have known about for over a year) would be at about 33M AS remaining which is very little, no matter how you think.
They currently have cash at least to Q2 2025, without any new revenues coming in.
Elfabrio has key payer coverage and will be launched in the next weeks time.
Literally all the fundamentals have improved and will further improve going forwards as the only other Fabry option in the biggest market the USA and a far better option to Replagal in the EU.
And it is now, because of 40M increase in 'Authorised Shares', that you've decided to freak out, despite an increase of 20M last time which literally nobody said anything about.
The disappointment is not in PLX, it is in those that give into fear and stupidity."
- Quite honestly the company hasn't done anything strange or untoward.
- Yes they decided to ask for the shareholder vote after the double approvals. But of course they did. They just announced great news for approval in 2 of the world's biggest markets and assumed that given that good news it would be a good time to do the shareholder vote and ask for the usual annual request that comes every single year. This year's requests were no different, nor were the content of the request being odd in any way.
The fundamentals are infinitely better, product has all the main US payers coverage and will be launched in the next few weeks, revenues will immediately start to come in both on Chiesi purchase of drug substance and revenues from sales, which we know will happen as predictables. Milestones hard to predict. I mean the Balance trial patients came into the study on -8eGFR slope despite mean of 6 years on Fabrazyme. Replagal Patients in the Bright study had their eGFR got from -5.9 to -1 which is the same as normal. And Elfabrio side effect profile is better vs both.
And just giving it a second to think about it, the increase of 40 million authorised shares is just prudent and responsible given the low 33 million count remaining they could be at. Nor does it mean that they will suddenly dump all the shares.
Honestly what more do people want from management? Really I'm highly keen to hear all rational suggestions.
As stated I'm not disappointed in PLX, I'm disappointed in and for those that capitulated to fear. But everyone reaps what they sow.
And great to write on iHub again, it's been awhile :)
Best,
Spidey
Reminder, Russell 3000 adds PLX tomorrow (Monday)
We should see a lot more volume going forward. Let's see if it helps the stock price.
Protalix BioTherapeutics to Host In-Person KOL Breakfast following the Approval of Elfabrio® in both the United States and the European Union for Adults with Fabry Disease
https://finance.yahoo.com/news/protalix-biotherapeutics-host-person-kol-105000869.html
Event will take place on Tuesday, June 27, 2023 in New York
CARMIEL, Israel, June 8, 2023 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell–based protein expression system, today announced it will host an in-person KOL breakfast in New York on Tuesday, June 27, 2023 at 8:00 a.m. Eastern Daylight Time (EDT), with presentations beginning at 8:30 a.m. EDT.
The event will feature a discussion of the recent approval by the U.S. Food and Drug Administration (FDA) of Elfabrio (pegunigalsidase alfa-iwxj) in the United States for the treatment of adult patients with Fabry disease. Ankit Mehta, M.D., FASN (Baylor University Medical Center) will discuss the opportunity for Elfabrio to address the unmet needs in Fabry disease; Giacomo Chiesi, Head of Chiesi Global Rare Diseases, the Company's commercial partner, will discuss Chiesi's commercial capabilities; and the Company's leadership will provide insight into the Company's strategy and future plans.
A live question and answer session will follow the presentations. Registration for the event is available at https://lifescievents.com/event/protalix/, or by clicking here.
About Ankit Mehta, MD, FASN
Dr. Mehta is fellowship-trained and board-certified in nephrology and internal medicine. His professional interests include management of patients with severe hypertension, glomerulonephritis, kidney stones and fluid electrolyte disorders. Dr. Mehta is a committed educator and currently serves as Program Director for the Department of Internal Medicine at Baylor University Medical Center, part of Baylor Scott & White Health. He attended medical school at Grant Medical College in Mumbai, India. Dr. Mehta's internship and residency in internal medicine took place at Baylor University Medical Center. He worked in hospital medicine for a year before going on to a fellowship in nephrology at Baylor, Dallas. Dr. Mehta is a practicing nephrologist with Dallas Nephrology Associates. He is also involved in research at Baylor Scott and White research institute and renal diseases. His research interests include anemia of chronic kidney disease, diabetic kidney disease, Alport's syndrome, polycystic kidney disease and various glomerulonephritis.
Of course that would be great to see. This is one I continue to accumulate on.
Zacks article: PLX target price & valuation $16
https://finance.yahoo.com/news/plx-back-envelope-150000398.html
This part was interesting:
----------------------------------------------------------------
"We performed a quick and conservative back of the envelope analysis to generate a base case valuation.
? Fabry Disease market size – $2 billion 2
? Potential market share – 15% – 50%
? Royalty from Chiesi – 15% to 40%
? Applied multiple of royalty revenues – 15x – 25x
? Convertible debt – rounded up to $30 mm
If we take the low end of each of these components and calculate a value, this produces a conservative enterprise value estimate of about $675 million. After subtracting convertible debt this gives us an equity value of $645 million or about $10 per share."
"Our target price and valuation are determined using a set of more realistic assumptions that produce a $16 target which we recently increased following the FDA approval of Elfabrio. These assumptions include peak penetration of 18% of US and ex-US markets, as well as a sum of royalty and milestone payments of up to 40% of product revenues."
This author knows almost nothing about this company, he doesn't even know how this company gets paid.
"If Protalix captures 1% of the market for 1,240 people, the company could make $372 million per year from Elfabrio. However, it will probably take 5 to 10 years to reach that point and there is no guarantee that it does. I'm just trying to provide some point of reference for Elfabrio's potential growth."
Protalix BioTherapeutics Stock: FDA Approval For Elfabrio To Drive Profitability
May 30, 2023 7:01 AM ET
Protalix BioTherapeutics, Inc. (PLX)
David Zanoni
Summary
Protalix received FDA and EU approval for Elfabrio.
This puts the company on track for profitability as early as 2023.
With a reasonable valuation and strong growth, I see a significant potential upside for PLX stock.
Protalix BioTherapeutics (NYSE:PLX) in partnership with Chiesi Global Rare Diseases achieved a milestone as it recently received FDA and EU approval for Elfabrio, a treatment for Fabry disease. The approval of Elfabrio puts the company on a realistic path to profitability as early as 2023. This catalyst along with a reasonable valuation can drive the stock for significant above-average gains.
Company Background
Protalix is currently a small cap ($141 million market cap) biopharmaceutical company with two FDA approved therapies on the market. Protalix develops plant-based proteins with better therapeutic profiles as part of its ProCellEx system. The company received its 1st FDA approval in partnership with Pfizer (PFE) for Elelyso for the treatment of Gaucher disease. The company had revenue of $47.6 million in 2022 with one FDA approval under its belt.
The company received positive news a few weeks ago for the FDA and EU approval of Elfabrio for the treatment of Fabry disease. This is an important milestone for Protalix. Elfabrio is projected to increase revenue for 2023 by about 33% to $63 million. In 2024, revenue is projected to grow 50% to nearly $95 million. Protalix is also projected to end 2023 with positive net income after many years of net losses.
Protalix is set to receive a $20 million milestone payment from its partner Chiesi upon the FDA approval of Elfabrio. Protalix is also eligible to receive up to $1 billion in regulatory and commercial milestone payments in addition to tiered royalties. The company expects cash & equivalents to increase to $51.6 million after receiving the $20 million milestone payment. That represents a 56.4% increase over Protalix's cash & equivalents of $33 million.
Protalix also has two therapeutics being developed in the pipeline. PRX-115 or Uricase is a plant-based cell-expressed recombinant human DNase I product candidate for the treatment of gout. PRX-119 is the company's therapeutic being developed for the treatment of NETs related diseases. PRX-115 is in Phase I development while PRX-119 is in a preclinical stage of development. So, it is likely to be multiple years before these therapies are considered for commercial marketing.
The Potential for Elfabrio
Elfabrio joins Sanofi's (SNY) Fabrazyme and Amicus Therapeutics' (FOLD) Galafold as FDA approved treatments for Fabry disease. Takeda (TAK) has Replagal approved in other countries for Fabry disease, but it has not been FDA approved. Sangamo Therapeutics (SGMO) has a gene therapy in a Phase 2 study for the treatment of Fabry disease. So, that may take a few years to achieve approval.
So, Protalix does have competition in the marketplace with possible future entries into the market. Elfabrio offers a new alternative treatment option for adults with Fabry disease. As a rare disease, the prevalence of Fabry disease is estimated to be about 11,000 people in the U.S. and about 113,000 people in the European Union. Treatments for Fabry disease cost over $300,000 per year. If Protalix captures 1% of the market for 1,240 people, the company could make $372 million per year from Elfabrio. However, it will probably take 5 to 10 years to reach that point and there is no guarantee that it does. I'm just trying to provide some point of reference for Elfabrio's potential growth.
One of the important factors for Protalix regarding the FDA and EU approval of Elfabrio is that the company is expected to become profitable in 2023 according to analyst estimates. Becoming profitable could have a positive effect on the stock.
One of the reasons for Protalix's potential for profitability is the company's strong gross margin of 59.6%, which is higher than the sector median GM of 55.8%. Another reason is the result of the company's plant cell production advantages which can be less expensive than competing production methods. Profitability can help the company invest back into the business for new therapeutics and possibly avoid or reduce the need for a share diluting capital raise.
Protalix's Plant Cell Production Advantages vs. mammillian cell expression and bacteria and yeast cell expression
Protalix's Plant Cell Production Advantages vs. Other Methods (Protalix 10-K)
Valuation is Attractive
Protalix is still valued attractively even after the recent FDA approval of Elfabrio. Protalix is trading with a trailing price/sales ratio of 2.57 and a forward price/sales of 2.2. This is significantly lower than the biotechnology industry's price/sales ratio of 8.88. Protalix also has an attractive forward PE of 12.9 as compared to its industry's forward PE of over 30.
One of the reasons for the attractive valuation is because the stock sold off after the FDA approval. The stock had a run up before the FDA approval decision. However, the actual FDA approval resulted in a sell-the-news reaction from investors. Therefore, investors can pick up the stock at a reasonable valuation before the next catalyst.
Technical Perspective
Protalix stock possible takeover target undervalued biotech
Protalix Stock Chart (Price, MACD, RSI) (tradingview.com)
The chart above shows the significant run up prior to the FDA approval of Elfabrio and the sell-the-news reaction after the decision was made. The stock peaked at the 52-week high of $3.55. The stock now appears to be holding the $2 level where it has multi-month support. The MACD indicator in the middle of the chart shows that the selling momentum has been reduced. However, the stock could also move lower on negative news such as the announcement of a share diluting capital raise.
Solid Balance Sheet
The recent $20 million milestone payment will bring Protalix's cash & equivalents up to $51.6 million. That is higher than the company's total debt of $33.6 million, giving them zero net debt.
Prior to the milestone payment, the company had 1.6x more current assets than current liabilities and 1.02x more total assets than total liabilities for total equity of $1 million. So, the milestone payment strengthens the company's balance sheet further. Of course, Protalix will need the extra cash to begin manufacturing Elfabrio for commercial sales. Now, the company is in a better financial position to execute it.
Possible Takeover Target
Small companies like Protalix can be takeover targets for larger companies to acquire. Protalix offers an attractive valuation with a soon to be profitable asset with Elfabrio. A takeover would typically occur at a premium price.
Outlook for Protalix
Although there is competition on the market for Fabry disease therapies, Elfabrio can allow Protalix to get its piece of the pie of the total market. Some Fabry disease patients might tolerate Elfabrio better than competing therapies.
Protalix is expected to be profitable in 2023 with projected EPS of $0.16. EPS is expected to grow to $0.63 in 2024. Revenue is expected to grow about 33% to $63 million in 2023 and increase 50% in 2024 to about $95 million. I expect the stock to make significant above-average gains if these estimates are met or exceeded.
The main risks for investors would be a share dilutive capital raise and/or sales and earnings expectations coming in worse than expected. These situations are likely to put negative pressure on the stock. Potential investors might want to wait to see if Protalix needs a capital raise to launch Elfabrio before buying the stock. Protalix should be considered as a highly risky stock due to these factors.
Given the low valuation, the potential for a profitable year, and strong growth expectations, I expect the stock to make strong gains over the next two years if things go well for the company. If Protalix's PE increased to the industry average of 30 and the company achieved EPS of $0.16 for 2023, the stock would increase to $4.80 within about a year. That would represent a 133% gain for the stock over the current price.
This article was written by
David Zanoni
9.44K Followers
Protalix BioTherapeutics Issues Letter to Stockholders
https://finance.yahoo.com/news/protalix-biotherapeutics-issues-letter-stockholders-105000485.html
CARMIEL, Israel, May 30, 2023 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today announced the following letter from its President and Chief Executive Officer, Dror Bashan, to its stockholders and the investment community.
Dear Protalix Stockholders,
As we arrive at the halfway point of this remarkable year, I would like to take a moment to celebrate our success, as well as share our excitement for the future of Protalix.
The spring commenced with a bang. Elfabrio®, our primary development candidate, has been approved for the treatment of adult patients with Fabry disease, both in the United States and the European Union. These approvals mark a significant milestone in our history. Although we faced challenges during our path toward regulatory approval, our team persevered, and you with us. These approvals are a true testament to our commitment to delivering innovative solutions to patients in need.
Elfabrio is the second approved therapy based on our proprietary ProCellEx® plant cell-based protein expression system, a unique platform conceived of and developed by Protalix and brought to fruition by the talented scientists making up our team. ProCellEx represents a relatively new method for developing recombinant proteins in an industrial-scale manner. Elelyso®, our first approved drug product, was the first protein produced through plant cell-based expression in suspension to be approved by the FDA.
Chiesi Global Rare Diseases, our commercial partner for Elfabrio, is well prepared for a successful commercial launch, and I have every confidence that they will realize the full potential of this much needed therapeutic option. I would like to extend my heartfelt gratitude to Chiesi.
Now that we stand on the other side of this accomplishment, we are turning our attention to our pipeline programs which have shown potential for growth. We are excited to focus on these development programs, armed with the knowledge gained from our hard-earned experiences. We plan to share our insights and future strategic initiatives with you and extend an invitation for you to join us at our upcoming in-person investors event on June 27, 2023 at 8:00 am ET at the Lotte Palace Hotel in New York City. Additional details and registration information will soon be available on our website.
We are profoundly grateful for your confidence in our company and for standing by us throughout the years. We are excited about the path ahead and the opportunity to connect with you during the upcoming event where we will discuss our future plans that we are designing to drive Protalix's growth. With your continued support, we will work towards a fruitful future, creating value for you, our investors and, most importantly, for patients and their families.
Sincerely,
Dror Bashan, President & Chief Executive Officer
About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. It is the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. This unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa for the treatment of Gaucher disease, Protalix's first product manufactured through ProCellEx, excluding in Brazil, where Protalix retains full rights. Protalix's second product, Elfabrio®, has been approved by both the FDA and the European Medicines Agency (EMA). Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio.
Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of severe gout; PRX–119, a plant cell-expressed long action DNase I for the treatment of NETs–related diseases; and others.
"In clinical trials" the elfabrio site states 29% experience infusion related reactions. The fabrazyme site says 59% of its patients do.
Protalix stock rises as biotech set to join Russell 3000 Index
May 23, 2023 11:27 AM ETProtalix BioTherapeutics, Inc. (PLX)
By: Ravikash, SA News Editor
Protalix BioTherapeutics (NYSE:PLX) stock rose ~8% on Tuesday after
the company said it is set to join the broad-market Russell 3000 Index
at the conclusion of the 2023 Russell indexes annual reconstitution,
effective June 26 when U.S. markets open.
The preliminary list of additions were posted
Excellent news. Protalix BioTherapeutics set to join Russell 3000® Index
https://finance.yahoo.com/news/protalix-biotherapeutics-set-join-russell-105000952.html
Take a look at the weekly as well, a LOT of running room.
https://finviz.com/quote.ashx?t=PLX&p=w
They got like $11M in cash instead of future $25M (which we do not when they were to be
due to PLX).
Protalix BioTherapeutics set to join Russell 3000® Index
CARMIEL, Israel, May 23, 2023 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell–based protein expression system, today announced that it is set to join the broad-market Russell 3000® Index at the conclusion of the 2023 Russell indexes annual reconstitution, effective after the US market opens on June 26, 2023 according to a preliminary list of additions posted May 19.
https://www.prnewswire.com/news-releases/protalix-biotherapeutics-set-to-join-russell-3000-index-301831972.html
That's correct, they gave up some potential milestone % for a debt related financial consideration, over a year ago if memory serves.
Most of the payments must be tied to commercial milestones and not regulatory milestones. So again we wait….
I remotely recall that Chiesi paid of some of
PLX debts in return to reduced milestone
$ amounts.
I'll try looking up this PLX-Chiesi agreement.
This was the initial agreement:
https://protalixbiotherapeutics.gcs-web.com/news-releases/news-release-details/protalix-biotherapeutics-expands-partnership-chiesi-farmaceutici
Protalix to receive $25 million upfront, an additional up to $20 million in development costs and an aProtalix BioTherapeutics Expands Partnership with Chiesi Farmaceutici to Include Exclusive U.S. Rights for the Development and Commercialization of PRX-102 (pegunigalsidase alfa) for thdditional up to $760 million in potential regulatory and commercial milestone payments for the U.S. rights
U.S. partnership includes tiered royalties ranging from 15% to 40% on net sales
CARMIEL, Israel, July 24, 2018 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®, today announced the expansion of its partnership with Chiesi Farmaceutici S.p.A., or Chiesi. Protalix and Chiesi entered into an exclusive U.S. license and supply agreement which grants to Chiesi the United States rights for the development and commercialization of PRX-102 (pegunigalsidase alfa), the Company’s chemically modified version of the recombinant protein alpha-Galactosidase-A protein, for the treatment of Fabry disease. In October 2017, Protalix announced an exclusive partnership with Chiesi for the development and commercialization of PRX-102 for the treatment of Fabry disease outside the United States.
Under the terms of the U.S. license and supply agreement, Protalix is entitled to an upfront payment of $25 million from Chiesi and additional payments of up to a maximum of $20 million in development costs, capped at $7.5 million per year. Protalix is also eligible to receive an additional up to a maximum of $760 million, in the aggregate, in regulatory and commercial milestone payments, and tiered royalties ranging from 15% to 40% on net sales as consideration for product supply. Protalix will continue to be the manufacturer of PRX-102 for clinical development and commercial purposes.
----------------------------------------------------------------------------------
This agreement was modified at By:
/s/ Eyal Rubin/s/ Dror Bashan
Title:CFOCEO
Name:Eyal RubinDror Bashan
Date:5/13/20215/13/2021
https://www.sec.gov/Archives/edgar/data/1006281/000155837021007157/plx-20210331xex10d3.htm
Well that explains the stock plummeting after approval. The payment is far lower than most had imagined.
Protalix BioTherapeutics Announces $20 Million Milestone Payment from Chiesi Global Rare Diseases
https://finance.yahoo.com/news/protalix-biotherapeutics-announces-20-million-105000631.html
Milestone payment triggered by FDA approval of ELFABRIO® (pegunigalsidase alfa-iwxj) and payable within 30 days of approval
CARMIEL, Israel, May 18, 2023 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell–based protein expression system, today announced that it is eligible to receive a $20 million milestone payment from its commercial partner, Chiesi Global Rare Diseases, a business unit of the Chiesi Group. The milestone payment was triggered by the approval by the U.S. Food and Drug Administration (FDA) of ELFABRIO (pegunigalsidase alfa-iwxj) for the treatment of adult patients with Fabry disease, which was announced on May 10, 2023, and is payable within 30 days of the FDA approval date.
"Receiving this milestone payment resulting from the FDA's approval of ELFABRIO is an important step for Protalix as it further to strengthens our financial position," said Dror Bashan, Protalix's President and Chief Executive Officer. "We continue to be grateful to our commercial partner, Chiesi, who has the global expertise to maximize the market potential of pegunigalsidase alfa."
On July 23, 2018, the Company's wholly-owned subsidiary entered into an Exclusive License and Supply Agreement with Chiesi Farmaceutici S.p.A., or Chiesi (the Chiesi US Agreement), pursuant to which the Company granted Chiesi an exclusive license to commercialize pegunigalsidase alfa in the United States. This followed the Exclusive License and Supply Agreement entered into with Chiesi on October 19, 2017 (the Chiesi Ex-US Agreement), pursuant to which Chiesi was granted an exclusive license to commercialize pegunigalsidase alfa in all markets outside of the United States. Under the two agreements, the Company has already received a total of $95.0 million in upfront payments and to cover development costs. In addition, under the two agreements, the Company is entitled to up to $1.0 billion in potential regulatory and commercial milestone payments, tiered royalties ranging from 15% to 40% of Chiesi's net sales in the United States and tiered royalties ranging from 15% to 35% of Chiesi's net sales outside the United States, as consideration for product supply.
On a proforma basis, including the receipt of the $20.0 million milestone payment, cash and cash equivalents as of May 18, 2023 is $51.6 million.
About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. It is the first company to gain U.S. Food and Drug Administration approval of a protein produced through plant cell-based in suspension expression system. This unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa for the treatment of Gaucher disease, Protalix's first product manufactured through ProCellEx, excluding in Brazil, where Protalix retains full rights. In addition, Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of PRX–102 (pegunigalsidase alfa).
Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of severe gout; PRX–119, a plant cell-expressed long action DNase I for the treatment of NETs–related diseases; and others.
I would disagree that the once per 4 week is very important for the market potential of Elfabrio, when compared to the equal efficacy and better safety, and probable real world better efficacy.
I think for this it is important to define the 'doing well on Fabrazyme'. Let us remember that from the clinical data, Fabrazyme causes ADAs/immunogenic response in 74% of patients.
So if we assume that doing well on Fabrazyme is in that 26% of patients, then yes, that person would be best suited to switch on to the once per 4 month dosing if/when available.
But the other 74%, even if doing well on the efficacy of Fabrazyme and generally well on more important side effects will still not be feeling great due to this ADA positive activity in their system.
Whereas in the Balance trial, patients with ADA's dropped when on Elfabrio, by 34% and dropped the neutralising antibodies by 55%.
And this is in patients who had already been on Fabrazyme for a mean of 6 years, so these are patients that are tolerating Fabrazyme well/or at least much better than others (clinical trial was in USA and 11 countries outside the USA).
So I think this type of patient (in the 74% ADA) doing well on Fabrazyme, would still be better off on Elfabrio. And this type of patient would already be accustomed to the once per 2 week regimen over many years of Fabrazyme, so it's not like Elfabrio is a detractor on that.
Thus for this type of patient in the 74% with ADAs would be a candidate for Elfabrio. Anyone doing well on efficacy and no adverse reaction and no ADAs would be fine to stay on Fabrazyme.
As remember in the Balance study, TEAE in total were 4x higher for Fabrazyme, and Infusion-Related-Reactions number and rate were 4x and 8x higher respectively for Fabrazyme.
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