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Protalix BioTherapeutics Studies First Quarter 2021 Monetary Outcomes and Enterprise Replace

CARMIEL, Israel, Could 14, 2021 /PRNewswire/ — Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical firm targeted on the event, manufacturing and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, as we speak reported monetary outcomes for the primary quarter ended March 31, 2021 and supplied a enterprise replace.

“Whereas the receipt of the Full Response Letter final month from the FDA was disappointing, we’re inspired that the FDA didn’t report any potential security or efficacy issues for PRX-102,” stated Dror Bashan, Protalix’s President and Chief Government Officer. “We’re working intently with the FDA and anticipate the required inspection and subsequent evaluation might be accomplished as soon as the FDA’s journey restrictions are lifted. We proceed to advance our earlier stage pipeline and anticipate continued progress all through 2021. We’re grateful for the help of our clinicians, sufferers, shareholders, Board members, workers and exterior companions and look ahead to constructing stockholder worth,” concluded Mr. Bashan.

2021 First Quarter and Current Enterprise Replace

Regulatory Updates

  • On April 28, 2021, the Firm, along with its improvement and commercialization companion, Chiesi Farmaceutici S.p.A., or Chiesi, introduced the receipt of a Full Response Letter (CRL) from the U.S. Meals and Drug Administration (FDA) concerning the Biologics License Utility (BLA) looking for accelerated approval of pegunigalsidase alfa, or PRX–102, for the proposed remedy of grownup sufferers with Fabry illness. The CRL didn’t report any issues referring to the potential security or efficacy of PRX-102 within the submitted knowledge bundle. Within the CRL the FDA famous an inspection of the Firm’s manufacturing facility in Carmiel, Israel, together with the FDA’s subsequent evaluation of any associated findings is required earlier than the FDA can approve the BLA. Because of journey restrictions referring to the COVID-19 pandemic, the FDA was unable to conduct the required inspection in the course of the evaluation cycle. The FDA defined that it’ll proceed to observe the general public well being state of affairs in addition to journey restrictions, and is actively working to schedule excellent inspections.

Medical Developments

  • On February 23, 2021, the Firm, along with Chiesi, introduced optimistic topline outcomes from the part III BRIGHT scientific trial, a examine designed to guage the protection, efficacy and pharmacokinetics of PRX–102 remedy, 2 mg/kg each 4 weeks, in as much as 30 sufferers with Fabry illness beforehand handled with a commercially out there enzyme substitute remedy (ERT) (agalsidase alfa – Replagal® or agalsidase beta – Fabrazyme®). Topline outcomes point out that 2 mg/kg of PRX-102 administered by intravenous infusion each 4 weeks was discovered to be effectively tolerated amongst handled sufferers, and steady scientific presentation was maintained in grownup Fabry sufferers.

Company & Monetary Developments

  • Given the receipt of the CRL, the Firm believes that it’s prudent to safe short-term funds to be able to proceed improvement of PRX-102 whereas ready for the FDA’s required inspection and subsequent evaluation described within the CRL. To take action, on Could 13, 2021, the Firm and Chiesi entered right into a binding time period sheet pursuant to which they amended the 2 unique license and provide agreements for PRX–102 to be able to present the Firm with near-term capital. Chiesi agreed to make a $10.0 million milestone cost to the Firm earlier than the top of  the second quarter in trade for a $25.0 million discount in a longer-term regulatory milestone cost within the Ex-US Unique License and Provide Settlement. All different regulatory and industrial milestone funds stay unchanged. The Firm and Chiesi additionally agreed to barter sure manufacturing associated issues.
  • On February 18, 2021, the Firm introduced the closing of a public providing of frequent inventory elevating gross proceeds of roughly $40.2 million earlier than deducting the underwriting low cost and estimated bills of the providing.
  • On February 10, 2021, the Firm entered into an unique partnership with SarcoMed USA Inc. for the worldwide improvement and commercialization of alidornase alfa, or PRX-110, to be used within the remedy of any human respiratory illness or situation together with, however not restricted to, sarcoidosis, pulmonary fibrosis and different associated ailments through inhaled supply.

Monetary Outcomes

For the three months ended March 31, 2021, in comparison with the three months ended March 31, 2020

  • The Firm recorded revenues from promoting items of $4.5 million in the course of the three months ended March 31, 2021, a lower of $0.5 million, or 10%, in comparison with revenues of $5.0 million for a similar interval of 2020. The lower of $3.0 million in gross sales to Brazil was partially offset by a rise of $2.5 million in gross sales to Pfizer Inc. or Pfizer.
  • Income from licenses and R&D companies was $6.8 million for the three months ended March 31, 2021, a lower of $9.8 million, or 59%, in comparison with revenues from license and R&D companies of $16.6 million for a similar interval in 2020. Revenues from license and R&D companies are comprised primarily of revenues we acknowledged in reference to the license and provide agreements with Chiesi. The lower resulted primarily from revenues for the three months ended March 31, 2020 acknowledged in reference to an up to date prices estimation all through the trials till completion, made in 2020, within the quantity of $6.7 million and from revenues acknowledged in reference to the progress of our scientific trials which have been accomplished throughout 2020.
  • Value of products bought was $4.8 million for the three months ended March 31, 2021, a rise of $1.4 million, or 41%, from value of products bought of $3.4 million for a similar interval in 2020. The rise in value of products bought was primarily the results of larger manufacturing prices.
  • Analysis and improvement bills had been $7.1 million for the three months ended March 31, 2021, a lower of $3.2 million, or 31%, in comparison with $10.3 million of analysis and improvement bills for a similar interval of 2020. The lower is primarily as a result of completion of two out of the three part III scientific trials of PRX–102 and lowered prices associated to the BALANCE Research. The Firm expects analysis and improvement bills to proceed to be its main expense because it enters right into a extra superior stage of preclinical and scientific trials for sure of its product candidates.
  • Promoting, common and administrative bills had been $3.1 million for the three months ended March 31, 2021, a lower of $0.1 million, or 3%, in comparison with $3.2 million for a similar interval of 2020.
  • Monetary bills, internet had been $1.8 million for the three months ended March 31, 2021, a lower of $1.2 million, or 40%, in comparison with monetary bills internet of $3.0 million for a similar interval of 2020. The lower resulted primarily from a lower in bills associated to the Firm’s excellent convertible notes equal to $1.3 million.
  • Money, money equivalents and short-term financial institution deposits had been roughly $70.4 million on March 31, 2021. In the course of the first quarter of 2021, the Firm raised gross proceeds of $8.8 million from the sale of frequent inventory beneath its ATM program and gross proceeds of $40.2 million through the general public providing of its frequent inventory.
  • Internet loss for the three months ended March 31, 2021 was roughly $5.5 million, or $0.14 per share, fundamental and diluted, in comparison with a internet earnings of $1.7 million, or $0.10 per share, fundamental and diluted, for a similar interval in 2020.

Convention Name and Webcast Data
The Firm will host a convention name as we speak, Could 14, 2021 at 8:30 am Japanese Daylight Time, to evaluation the scientific, company, and monetary highlights, which may also be out there by webcast. To take part within the convention name, please dial the next numbers previous to the beginning of the decision:

Convention Name Particulars:
Friday, Could 14, 2021, 8:30 a.m. Japanese Daylight Time (EDT)
Home:  877-423-9813
Worldwide:  201-689-8573
Convention ID:  13719725

The convention name might be webcast dwell from the Firm’s web site and might be out there through the next hyperlinks:

Webcast Particulars:
Firm Hyperlink:  https://protalixbiotherapeutics.gcs-web.com/events0  
Webcast Hyperlink:  https://tinyurl.com/bnd6y9ch 
Convention ID:  13719725

Please entry the web sites at the least quarter-hour forward of the convention to register, obtain and set up any vital audio software program.

The convention name might be out there for replay for 2 weeks on the Occasions Calendar of the Traders part of the Firm’s web site, on the above hyperlink.

About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical firm targeted on the event and commercialization of recombinant therapeutic proteins expressed by its proprietary plant cell-based expression system, ProCellEx®. Protalix was the primary firm to achieve FDA approval of a protein produced by plant cell-based in suspension expression system. Protalix’s distinctive expression system represents a brand new methodology for creating recombinant proteins in an industrial-scale method.

Protalix’s first product manufactured by ProCellEx, taliglucerase alfa, was permitted by the FDA in Could 2012 and, subsequently, by the regulatory authorities of different international locations. Protalix has licensed to Pfizer Inc. the worldwide improvement and commercialization rights for taliglucerase alfa, excluding Brazil, the place Protalix retains full rights.

Protalix’s improvement pipeline consists of proprietary variations of recombinant therapeutic proteins that focus on established pharmaceutical markets, together with the next product candidates: pegunigalsidase alfa, a modified stabilized model of the recombinant human α–Galactosidase–A protein for the remedy of Fabry illness; alidornase alfa or PRX-110, for the remedy of assorted human respiratory ailments or situations; PRX–115, a plant cell-expressed recombinant PEGylated uricase for the remedy of refractory gout; PRX–119, a plant cell-expressed lengthy motion DNase I for the remedy of NETs-related ailments; and others. Protalix has partnered with Chiesi Farmaceutici S.p.A., each in the US and outdoors the US, for the event and commercialization of pegunigalsidase alfa, and with SarcoMed USA, Inc. for the worldwide improvement and commercialization of PRX–110 to be used within the remedy of any human respiratory illness or situation together with, however not restricted to, sarcoidosis, pulmonary fibrosis, and different associated ailments through inhaled supply.

Ahead-Trying Statements
To the extent that statements on this press launch should not strictly historic, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Non-public Securities Litigation Reform Act of 1995. The phrases “count on,” “anticipate,” “consider,” “estimate,” “undertaking,” “might,” “plan,” “will,” “would,” “ought to” and “intend,” and different phrases or phrases of comparable import are supposed to establish forward-looking statements. These forward-looking statements are topic to identified and unknown dangers and uncertainties that will trigger precise future expertise and outcomes to vary materially from the statements made. These statements are based mostly on our present beliefs and expectations as to such future outcomes. Drug discovery and improvement contain a excessive diploma of danger and the ultimate outcomes of a scientific trial could also be completely different than the preliminary findings for the scientific trial. Elements that may trigger materials variations embody, amongst others: dangers associated to the timing and progress of the preparation of an up to date BLA addressing the whole response letter; dangers associated to the timing, progress and chance of ultimate approval by the FDA of a resubmitted BLA for PRX–102 and, if permitted, whether or not the usage of PRX-102 might be commercially profitable; the chance that the FDA, the European Medicines Company, or EMA, or different overseas regulatory authorities might not settle for or approve a advertising utility the Firm recordsdata for any of its product candidates; failure or delay within the graduation or completion of our preclinical research and scientific trials, which can be brought on by a number of elements, together with: slower than anticipated charges of affected person recruitment; unexpected questions of safety; dedication of dosing points; lack of effectiveness throughout scientific trials; lack of ability or unwillingness of medical investigators and institutional evaluation boards to observe our scientific protocols; and lack of ability to observe sufferers adequately throughout or after remedy; dangers referring to the Firm’s skill to make required funds beneath its excellent convertible notes or another indebtedness as they arrive due and the Firm’s skill to acquire extra financing and lift capital as vital ought to the regulatory approval course of develop into extra prolonged; dangers related to the novel coronavirus illness, or COVID-19, outbreak, which can adversely influence our enterprise, preclinical research and scientific trials; dangers associated to any transactions we might impact within the public or personal fairness markets to boost capital to finance future analysis and improvement actions, common and administrative bills and dealing capital; danger of serious lawsuits, together with stockholder litigation, which is frequent within the life sciences sector; the chance that the outcomes of the scientific trials of our product candidates won’t help the relevant claims of security or efficacy, or that our product candidates won’t have the specified results or might be related to undesirable unintended effects or different sudden traits; dangers associated to our skill to take care of and handle our relationship with our collaborators, distributors or companions; dangers associated to the quantity and sufficiency of our money and money equivalents; our dependence on efficiency by third social gathering suppliers of companies and provides, together with with out limitation, scientific trial companies; delays in our preparation and submitting of functions for regulatory approval; delays within the approval or potential rejection of any functions we file with the FDA, EMA or different well being regulatory authorities, and different dangers referring to the evaluation course of; the inherent dangers and uncertainties in creating drug platforms and merchandise of the sort we’re creating; the influence of improvement of competing therapies and/or applied sciences by different corporations and establishments; potential product legal responsibility dangers, and dangers of securing satisfactory ranges of product legal responsibility and different vital insurance coverage protection; and different elements described in our filings with the U.S. Securities and Trade Fee. The statements on this press launch are legitimate solely as of the date hereof and we disclaim any obligation to replace this info, besides as could also be required by legislation.

Brand – https://mma.prnewswire.com/media/999479/Protalix_Biotherapeutics_Logo.jpg

Investor Contact
Chuck Padala, Managing Director
LifeSci Advisors
+1-646-627-8390
[email protected]

PROTALIX BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(U.S. {dollars} in 1000’s)

(Unaudited)












March 31, 2021


December 31, 2020










ASSETS
















CURRENT ASSETS:








Money and money equivalents


$

19,830


$

18,265


Quick-term financial institution deposits



50,600



20,280


Accounts receivable – Commerce



4,599



2,000


Different belongings



1,754



2,096


Inventories



13,915



13,082


Whole present belongings


$

90,698


$

55,723










NON-CURRENT ASSETS:








Funds in respect of worker rights upon retirement


 

$

1,776


$

1,799


Property and tools, internet



4,828



4,845


Working lease proper of use belongings



5,490



5,567


Whole belongings


$

102,792


$

67,934










LIABILITIES AND STOCKHOLDERS’ EQUITY (NET OF CAPITAL DEFICIENCY)
















CURRENT LIABILITIES:








Accounts payable and accruals:








Commerce


$

6,376


$

7,221


Different



15,167



13,926


Working lease liabilities



1,386



1,420


Contracts legal responsibility



2,560



5,394


Convertible notes



55,372



54,427


Promissory be aware






4,086


Whole present liabilities


$

80,861


$

86,474










LONG TERM LIABILITIES:








Contracts legal responsibility



858



1,716


Legal responsibility for worker rights upon retirement



2,224



2,263


Working lease liabilities



4,319



4,467


Different long run liabilities



26



51


Whole long run liabilities


$

7,427


$

8,497


Whole liabilities


$

88,288


$

94,971










STOCKHOLDERS’ EQUITY (CAPITAL DEFICIENCY)



14,504



(27,037)


Whole liabilities and stockholders’ fairness (internet of capital deficiency)


$

102,792


$

67,934


PROTALIX BIOTHERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(U.S. {dollars} in 1000’s, besides share and per share knowledge)

(Unaudited)












Three Months Ended




March 31, 2021


March 31, 2020


REVENUES FROM SELLING GOODS


$

4,511


$

5,031


REVENUES FROM LICENSE AND R&D SERVICES



6,809



16,615


TOTAL REVENUE



11,320



21,646


COST OF GOODS SOLD (1)



(4,765)



(3,426)


RESEARCH AND DEVELOPMENT EXPENSES, NET (2)



(7,122)



(10,340)


SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (3)



(3,138)



(3,187)


OPERATING INCOME (LOSS)



(3,705)



4,693


FINANCIAL EXPENSES



(2,156)



(3,229)


FINANCIAL INCOME



335



203


FINANCIAL EXPENSES – NET



(1,821)



(3,026)


OTHER INCOME



51





NET INCOME (LOSS) FOR THE PERIOD


$

(5,475)


$

1,667


EARNINGS (LOSS) PER SHARE OF COMMON STOCK – BASIC AND DILUTED


$

(0.14)


$

0.10


WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK








USED IN COMPUTING EARNINGS (LOSS) PER SHARE – BASIC AND DILUTED



39,933,972



17,381,074


(1) Consists of share-based compensation


$

109


$



(2) Consists of share-based compensation


$

210


$

78


(3) Consists of share-based compensation


$

497


$

353


SOURCE Protalix BioTherapeutics, Inc.

Associated Hyperlinks

https://protalix.com

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