Source: Streetwise Reports   04/23/2020

Shares of West Pharmaceutical Services traded higher and established a new 52-week high price after the firm reported Q1/20 earnings that included a 10.8% increase in YoY revenues.

Global healthcare packaging components manufacturer company West Pharmaceutical Services Inc. (WST:NYSE) today announced financial results for its first quarter ending March 31, 2020 and provided updated full-year 2020 financial guidance.

The company reported that net sales in Q1/20 increased to $491.5 million, a 10.8% increase from $443.5 million in Q1/19. During the same corresponding period, the firm stated that non-GAAP diluted earnings per share (EPS) increased by 36% to $0.99 and non-GAAP adjusted-diluted EPS increased by 36% to $1.01.

West Pharmaceutical Services advised that it is maintaining its FY/20 net sales guidance, which is expected to be in a range of $1.95-1.97 billion. The company stated that it is updating FY/20 adjusted-diluted EPS guidance to a new range of $3.52-3.62, compared to the prior estimated range of $3.45-3.55.

The company's President and CEO Eric M. Green commented, "During these unprecedented times, our priorities are focused on the well-being and safety of our team members as well as ensuring the supply of critical, high-quality components and solutions to our customers...I am extremely pleased that we delivered a strong performance in the first quarter given the challenging environment that the COVID-19 pandemic has had on our customers, our suppliers and our team members. In particular, we continued to deliver strong sales growth in high-value products, as demand trends from our worldwide customer base were similar to trends we saw last year. Our teams are partnering with a broad range of customers working to support efforts to develop solutions that address the global COVID-19 pandemic such as diagnostics, anti-viral therapeutics and vaccines."

The firm outlined sales in the most recent quarter by product line. The company reported that in Q1/20, net sales in its Proprietary Products segment grew by 9.7% to $373.5 million and that this segment "saw good demand for Westar^®, Daikyo^®, NovaPure^® and FluroTec^® components as well as for devices such as Daikyo Crystal Zenith^® syringes and cartridges and our self-injection platforms."

The firm noted that net sales from its Contract-Manufactured Products segment grew by 14.5% to $118.1 million led by sales of components for diagnostic devices and drug-injection delivery devices.

The company added that the Biologics market unit enjoyed double-digit organic sales growth, the Generics market unit achieved high-single digit organic sales growth and the Pharma market unit registered mid-single digit organic sales growth.

The firm additionally noted that during Q1/20 under its share repurchase program, it repurchased 761,500 shares for $115.5 million at an average share price of $151.65.

West Pharmaceutical Services is headquartered in Exton, Pa., roughly 35 miles west of Philadelphia, and is a designer and manufacturer of injectable pharmaceutical packaging and delivery systems.

West Pharmaceutical has market capitalization of around $13.5 billion with approximately 73.84 million shares outstanding. WST shares opened 5.25% higher today at $179.05 (+$8.93, +5.25%) over yesterday's $170.12 closing price and reached a new 52-week high price this morning of $190.27. The stock has traded today between $177.13 and $190.27 per share and is currently trading at $187.04 (+$17.17, +10.11%).

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Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: WST:NYSE, )

Source: Streetwise Reports   05/06/2020

ProMIS is harnessing its unique technology platform to develop a more error-free antibody test.

Testing has been an Achilles heel of the coronavirus pandemic, but ProMIS Neurosciences Inc. (PMN:TSX; ARFXF:OTCQB) has partnered with Dr. Hans Frykman and the BC Neuroimmunology Lab to use its unique technology to create a more accurate antibody test for SARS-CoV-2, the virus that causes Covid-19.

Two main types of tests exist for Covid-19: one that detects the presence of the virus that causes Covid-19, which indicates a person has an active infection, and another that detects antibodies, showing that a person has been exposed to the virus.

The first test that was developed, a test for the presence of the virus, is used mainly to confirm diagnosis of Covid-19 in people who are showing symptoms such as a fever, a dry, persistent cough, difficulty breathing, a sense of restriction in the chest. "They are typical signs of Covid-19, but we would want to know if these are signs of the common flu or a bad cold or Covid-19. We know that Covid can progress really significantly very quickly, especially in individuals with underlying conditions," ProMIS CEO Dr. Elliot Goldstein told Streetwise Reports. "The number of tests is limited, but it's not actually the tests themselves but the reagents and systems you need to run the test that are in short supply."

"Anytime you conduct a test for the virus and get a negative response, the test indicates only that on that day at that time, the person does not have the virus. The person could have had Covid and recovered, or might have had an asymptomatic or very mild case. Or that person could get the virus tomorrow or in three days," Dr. Goldstein explained. "At any point in time the virus test helps indicate the prevalence of the virus—how many people are actually infected—if you test broadly, and at the time you do it, you can determine whether an individual is currently infected or not."

The second type of test, called serological tests or assays, is also known as an antibody test. "When a person is recovering from a viral infection, the immune system makes antibodies—also called immunoglobulins—that are specific to the virus. They neutralize the virus and help clear it out; that's part of the mechanism of why you get better," Dr. Goldstein explained.

One way to see if a person has had Covid is to test for antibodies. "A positive test means you've been exposed to the virus because, in the absence of a vaccine, that's the only way you would have the antibodies. While it's not 100% certain that antibodies neutralize the virus, based on experience with other coronaviruses, it is likely," Dr. Goldstein said. Having the virus neutralized should offer at least some protection against future re-infections.

People who have had positive virus tests know that they have Covid or had Covid and recovered, but many people are asymptomatic or may have had what felt like a light cold, and they want to know if they are at risk, or if they have some protection against the disease. "This is really important for frontline healthcare workers, people working 8-10 hours a day in intensive care or the emergency room with patients known to be very sick with Covid-19; even with protective equipment, they have significant exposure to the virus," Dr. Goldstein explained. "If someone has been through the disease and has natural antibodies, they can't infect someone else. What you want to know on an individual level is am I safe from infection and am I safe for other people."

Generally, antibody testing is a fairly common procedure, Dr. Goldstein explained. When you spin blood in a centrifuge, it separates into three parts: red blood cells, plasma and serum. Serum is where you find antibodies. "ELISA (enzyme-linked immunosorbent assay) is a standard test that looks for antibodies, but it is not specific enough for the Covid-19 virus."

The challenge is there are multiple coronaviruses. "Four different coronaviruses are responsible for the common cold, and then there are others like SARS and MERS. They all have the same sort of halo or corona of protein around the outside of it," Dr. Goldstein said. "They look like the old naval mines used in war. The whole family of coronaviruses look like that. The amino acid sequences of different coronaviruses are not identical but very similar; they share a lot of common structures. There are only really small differences and you can't really pick them up using the usual physical methods."

Studies have shown that up to 90% of individuals in Western countries have been exposed to one or more of the common cold coronaviruses and have antibodies against them. "They look very similar to the coronavirus causing Covid-19. So in Covid-19 antibody tests, the most important thing is it has to be highly specific for the Covid-19 antibodies and doesn't test positive when it identifies a common cold antibody. That is a false positive," said Dr. Goldstein. "It's actually much safer not to have a test that has a lot of false positives because you could base a behavioral decision on faulty information."

Dr. Goldstein cited an example. "If you are testing 1,000 people and there is a 90% prevalence for the cold virus, that means around 900 people have antibodies to the common cold. If the prevalence of the Covid-19 virus is 2%, roughly 20 of the 1,000 would have antibodies to the Covid-19 virus. Let's say the serology test has 95% specificity. That means five times out of 100, it will give a false positive, indicating the presence of Covid-19 antibodies when it is really picking up antibodies against the cold virus. What this means is 5% of 900, or 45 people, will test positive for Covid when they have not had it, and are making decisions based on incorrect information. The consequences of being wrong are dramatic and highlight the need for a very good, high-quality serological test."

How does this relate to Alzheimer's and other neurological diseases that are ProMIS' core competency? "In Alzheimer's, ALS, frontotemporal dementia, Parkinson's disease and other neurological disease, we've been able to use our proprietary, unique technology to identify sites on misfolded proteins that are driving these diseases. Our core technology is the capability to understand what's special about the bad proteins that are causing these diseases and then we can make antibodies highly selective against them. Our technology allows us to identify a region, an epitopes target, which is a series of four to six amino acids where the protein has misfolded. Not only do we know where this target site is located, importantly we also determine the shape (conformation) of this site. Proteins like amyloid and alpha synuclein and TDP 43 misfold and when these proteins misfold they become toxic, they kill neurons, resulting in disease," Dr. Goldstein explained.

ProMIS has transferred that thinking to the virus causing Covid-19. "The corona is composed of the spiky protein. Remember, we want to be able to distinguish between the coronavirus causing the common cold and the coronavirus causing Covid-19," Dr. Goldstein said. "If we can distinguish between the two, we can have an antibody test that's specific for Covid-19. We are looking at a region of the virus called the receptor binding domain, the RBD, that is part of the spike protein and how it attaches to cells. We have a core competency that allows us to identify sites, and not just the location of the sites, but the shape of the sites on complex protein molecules. That allows us then to use that knowledge to create either antibodies or to create serum tests, or even quite frankly, we can use those targets to create vaccines."

Using ProMIS' proprietary technology, the company has been able to "identify a site that we believe is only present on the Covid-19 virus and not on other coronaviruses. We are now initiating the synthesis of several different forms of that site; it's a small area," Dr. Goldstein stated. "That would then transfer to Dr. Hans Frykman's lab at University of British Columbia, a world-class serology lab. Then we will see if the targets we've identified are specific and selective antibodies against Covid-19."

When you test the serum of an individual, if they've been exposed to the virus and have the antibodies, "those antibodies should bind selectively and specifically to the target. So if the antibodies from the patient's serum are binding to the target site, we know it's a Covid-19 virus because that site is only visible in that shape on the Covid-19 virus and not the others. For the validation of our test, only in patients known to have had Covid-19 should we see binding of antibodies against Covid-19 to our target. The second validation is based on testing in serum from subjects known to have never been exposed to Covid-19 virus—such subjects have antibodies only from cold or other coronaviruses, and therefore the antibody test should be negative; there should be no binding. So we should only see binding in serum from a patient known to have recovered from COVID-19, and we should not see binding in serum from an individual known not to have been exposed to COVID-19," Dr. Goldstein explained.

"Our technology basically allows us to zero in with sniper-like precision on the structure of a protein and understand it, not only the structure overall but the shape of the regions on that protein and then that allows us to identify what is specific to that protein, in this case the spiky protein on the virus causing COVID-19," said Dr. Goldstein.

ProMIS expects to have initial results in June.

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Disclosure:
1) Patrice Fusillo compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: ProMIS Neurosciences. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of ProMIS, a company mentioned in this article.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: PMN:TSX; ARFXF:OTCQB, )

Source: Streetwise Reports   05/05/2020

Shares of Portola Pharmaceuticals traded 130% higher after the company reported that it has received an $18 per share buyout offer from Alexion Pharmaceuticals.

Commercial-stage biotechnology company Portola Pharmaceuticals Inc. (PTLA:NASDAQ), which focuses on blood-related disorders, and global biopharmaceuticals firm Alexion Pharmaceuticals Inc. (ALXN:NASDAQ) announced that they have entered into a definitive merger agreement for Portola to be acquired by Alexion.

The acquisition is said to provide a key addition to Alexion's diversified commercial portfolio. The report indicated that the merger agreement has already been unanimously approved each of the company's boards of directors.

The report explained that "Portola's commercialized medicine, Andexxa^® [coagulation factor Xa (recombinant), inactivated-zhzo], marketed as Ondexxya^® in Europe, is the first and only approved Factor Xa inhibitor reversal agent, and has demonstrated transformative clinical value by rapidly reversing the anticoagulant effects of Factor Xa inhibitors rivaroxaban and apixaban in severe and uncontrolled bleeding."

Portola's President and CEO Scott Garland commented, "In developing and launching Andexxa, Portola has established a strong foundation for changing the standard of care for patients receiving Factor Xa inhibitors that experience a major, life-threatening bleed. Andexxa rapidly reverses the pharmacologic effect of rivaroxaban and apixaban within two minutes, reducing anti-Factor Xa activity by 92 percent...Given their enhanced resources, global footprint and proven commercial expertise, we look forward to working with Alexion to maximize the value of Andexxa. With their commitment to commercial excellence, together, we will be able to drive stronger utilization of Andexxa, increase penetration and accelerate adoption in the critical care setting."

Ludwig Hantson, Ph.D., CEO of Alexion, remarked, "The acquisition of Portola represents an important next step in our strategy to diversify beyond C5. Andexxa is a strategic fit with our existing portfolio of transformative medicines and is well-aligned with our demonstrated expertise in hematology, neurology and critical care...We believe Andexxa has the potential to become the global standard of care for patients who experience life-threatening bleeds while taking Factor Xa inhibitors apixaban and rivaroxaban. By leveraging Alexion's strong operational and sales infrastructure and deep relationships in hospital channels, we are well positioned to expand the number of patients helped by Andexxa, while also driving value for shareholders."

The firms advised that "under the terms of the merger agreement, a subsidiary of Alexion will commence a tender offer to acquire all of the outstanding shares of Portola's common stock at a price of $18 per share in cash." Alexion plans to fund the purchase with existing cash on hand and the transaction is expected to close in Q3/20. The purchase is subject to approval by a majority interest of Portola's common stockholders tendering their shares along with ordinary closing conditions and regulatory approvals. The company noted that "following successful completion of the tender offer, Alexion will acquire all remaining shares not tendered in the offer at the same price of $18 per share through a merger."

Alexion is a global biopharmaceutical company based in Boston, Mass., with offices in 50 countries worldwide. The company states that it has been "the global leader in complement biology and inhibition for more than 20 years and that it has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor antibody-positive generalized myasthenia gravis and neuromyelitis optica spectrum disorder."

Portola is headquartered in South San Francisco, Calif., and is a commercial-stage biopharmaceutical company focused on treating patients with serious blood-related disorders. Specifically, the company is engaged in developing and commercializing novel therapeutics in order to advance the fields of thrombosis and other hematologic conditions. The firm listed that its first two commercialized products are Andexxa^® and Bevyxxa^® (betrixaban), and that it is also advancing and developing cerdulatinib, a SYK/JAK inhibitor for use in treatment of hematologic cancers.

Portola Pharmaceuticals started off the day with a market capitalization of around $609.0 million with approximately 78.5 million shares outstanding and a short interest of about 23.0%. PTLA shares opened 130% higher today at $17.85 (+$10.09, +130.03%) over yesterday's $7.85 closing price. The stock has traded today between $17.71 and $17.91 per share and is currently trading at $17.83 (+$10.07, +129.77%).

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Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

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