Source: Streetwise Reports   04/24/2020

Mesoblast Ltd. (MESO:NASDAQ; MSB:ASX) today announced that it had achieved an "83% survival in ventilator-dependent COVID-19 patients (10/12) with moderate/severe acute respiratory distress syndrome (ARDS) treated during the period March-April 2020 with two intravenous infusions of Mesoblast's allogeneic mesenchymal stem cell product candidate remestemcel-L within the first five days." The company stated that of the 12 patients treated, 75% (9/12) successfully came off ventilator support after a median timeframe of 10 days. The firm advised that all of the patients were treated under an emergency Investigational New Drug (IDA) application or expanded access protocol at Mt. Sinai hospital in New York City and so far seven of the patients have been discharged from the hospital. The company noted that each of the patients had received a variety of experimental agents prior to being treated with remestemcel-L.

The firm explained that until now only about 9% (38/445) of ventilator-dependent COVID-19 patients at a major referral hospital network in New York City were able to come off ventilator support when treated with existing standard of care treatments during March and April 2020. The company reported that at a second major referral hospital network in New York City over the same period, there was 88% mortality with only 12% survival (38/320) among ventilator-dependent COVID-19 patients.

The company's CEO Dr. Silviu Itescu commented, "The remarkable clinical outcomes in these critically ill patients continue to underscore the potential benefits of remestemcel-L as an anti-inflammatory agent in cytokine release syndromes associated with high mortality, including acute graft versus host disease and COVID-19 ARDS. We intend to rapidly complete the randomized, placebo-controlled Phase 2/3 trial in COVID-19 ARDS patients to rigorously confirm that remestemcel-L improves survival in these critically ill patients."

Dr. Fred Grossman, Mesoblast's Chief Medical Officer, added, "There is a significant need to improve the dismal survival outcomes in COVID-19 patients who progress to ARDS and require ventilators. We have implemented robust statistical analyses in our Phase 2/3 trial as recommended by the US Food and Drug Administration (FDA) in order to maximize our ability to evaluate whether remestemcel-L provides a survival benefit in moderate/severe COVID-19 ARDS."

Mesoblast Ltd. is headquartered in Melbourne, Australia, and is a developer of industrial-scale, cryopreserved, off-the-shelf allogeneic cellular medicines. The company utilizes its proprietary mesenchymal lineage cell therapy technology platform in order to create a wide portfolio of commercial products and late-stage product candidates. The firm indicated that "the Biologics License Application to seek approval of its product candidate RYONCIL™ (remestemcel-L) for steroid-refractory acute graft versus host disease has been accepted for priority review by the U.S. Food and Drug Administration." The company has offices in Australia, the U.S. and Singapore.

Mesoblast began the day with a market capitalization of around $687.9 million with approximately 106.7 million shares outstanding. MESO shares opened nearly 142% higher today at $15.59 (+$9.14, +141.71%) over yesterday's $6.45 closing price and reached a new 52-week high price this morning of $20.57. The stock has traded today between $13.01 and $20.57 per share and is presently trading at $14.76 (+$8.30, +128.76%).

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: MESO:NASDAQ; MSB:ASX, )

Source: Streetwise Reports   04/27/2020

Avadel Pharmaceuticals Plc (AVDL:NASDAQ) today announced "positive topline data from its pivotal Phase 3 REST-ON trial assessing the safety and efficacy of FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy." The firm pointed out that it met all three of the co-primary efficacy endpoints in the study for each of three dosage levels which it claims demonstrates "highly significant, clinically meaningful improvements on the Maintenance of Wakefulness Test, Clinical Global Impression-Improvement and mean weekly cataplexy attacks."

The company's Chief Medical Officer Jordan Dubow, M.D., commented, "We are excited to see these positive topline data from the REST-ON study, where all three dose levels of once-nightly FT218 demonstrated a statistically significant and clinically meaningful improvement on the measures of the two prominent symptoms of narcolepsy, as well as an improvement in overall functioning compared to placebo...Once-nightly FT218 delivered a clinically meaningful response within three weeks of treatment initiation, which was sustained through each treatment period...We think once-nightly FT218, if approved, has the potential to be a meaningful contributor to patient care."

Avadel Pharma's CEO Greg Divis remarked, "The successful outcome of the REST-ON study strengthens our belief that, if approved, once-nightly FT218 has the potential to be a significant advancement for patients in the estimated $1.7 billion twice-nightly sodium oxybate market. Our proprietary market research with physicians and patients informs us that there is a strong interest in a once-nightly sodium oxybate formulation. We look forward to sharing the results from the REST-ON study with the FDA and progressing toward a potential approval that would allow us to bring this important treatment to the patients who need it most. If approved, FT218 would be the first once-nightly therapy to address both excessive daytime sleepiness and cataplexy in patients with narcolepsy."

The REST-ON study is a double-blind, randomized, placebo-controlled Phase 3 trial to assess the efficacy and safety of once-nightly FT218, a formulation of sodium oxybate using Avadel's proprietary Micropump technology for extended-release oral suspension in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. The company stated that 212 patients were enrolled in the study and result "showed that the 9 g dose of once-nightly FT218 demonstrated a highly significant and clinically meaningful improvement compared to placebo across all three co-primary endpoints."

The company advised that FT218 has been granted Orphan Drug Designation from the U.S. FDA for the treatment of narcolepsy. The firm added that the designation was granted on basis that FT218 may be clinically superior to a formulation of sodium oxybate that is already approved by the FDA for the same indication.

Avadel Pharmaceuticals is biopharmaceutical company headquartered in Dublin, Ireland. The company's primary focus is on the development and potential FDA approval for FT218, which just completed its Phase 3 REST-ON clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness and cataplexy. The firm also develops and markets sterile injectable drugs for use in hospital settings.

Avadel started off the day with a market capitalization of around $456.2 million with approximately 46.4 million shares outstanding and a short interest of about 14.00%. AVDL shares opened more than 34% higher today at $13.30 (+$3.37, +34.28%) over Friday's $9.83 closing price and reached a new 52-week high price this morning of $13.49. The stock has traded today between $11.90 and $13.49 per share and is currently trading at $12.27 (+$2.44 +24.82%).

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: AVDL:NASDAQ, )

Source: Streetwise Reports   04/29/2020

Biopharmaceutical company Chimerix Inc. (CMRX:NASDAQ), which focuses on developing medicines to treat cancer and other serious diseases, today announced that it will initiate a Phase 2/3 study of dociparstat sodium (DSTAT) in COVID-19 patients suffering from acute lung injury (ALI).

The firm explained that "DSTAT is a glycosaminoglycan derivative of heparin with robust anti-inflammatory properties, including the potential to address underlying causes of coagulation disorders with substantially reduced risk of bleeding complications compared to commercially available forms of heparin.^"

Joseph Lasky, M.D., Professor of Medicine, Pulmonary and Critical Care Section Chief, John W. Deming, M.D. Endowed Chair in Internal Medicine at Tulane University Medical School commented, "Given the severity of the COVID-19 pandemic, we have evaluated many potential targets to address the clinical manifestations associated with severe COVID-19...Based on the literature, we believe DSTAT has the potential to reduce the excessive inflammation, immune cell infiltration and hypercoagulation associated with poor outcomes in patients with severe COVID-19 infection."

The company's CEO Mike Sherman remarked, " DSTAT is well-suited to unlock the anti-inflammatory properties of heparin as it may be dosed at much higher levels than any available form of heparin without triggering bleeding complications...We had planned to evaluate DSTAT in several indications of high unmet need, including ALI from different causes. The pandemic intensified our focus on ALI associated with COVID-19. Our team has worked closely with critical care physicians treating COVID-19 patients and with the U.S. Food and Drug Administration (FDA) to develop a Phase 2/3 protocol to determine if DSTAT can reduce the need for mechanical ventilation and improve the rate of survival in patients with severe COVID-19 infection."

The company outlined its plans for the study indicating that it will be a randomized, double-blind Phase 2/3 trial to determine the safety and efficacy of DSTAT in adults with severe COVID-19 who are at a high risk of respiratory failure. The study subjects will be confirmed COVID-19 patients who require hospitalization and supplemental oxygen therapy. The primary endpoint established in the study is the percentage of subjects who survive and do not require mechanical ventilation through 28 days. Several secondary endpoints listed include time needed for showing improvement, time to hospital discharge, time to resolution of fever, number of ventilator-free days, all-cause mortality and changes in several key biomarkers.

The study will begin by enrolling 24 subjects in Phase 2 to first establish dosage levels and then expand to 74 total patients. The firm advised that if Phase 2 results are positive, it would enroll approximately 450 subjects in the Phase 3 portion of the study.

The company reported that "the clinical manifestations of COVID-19 range from mild, self-limited respiratory tract illness to severe alveolar damage and progressive respiratory failure, multiple organ failure, and death. Mortality in COVID-19 is associated with severe pulmonary disease and coagulation disorders such as disseminated intravascular coagulation." The firm indicated that the mechanisms of action of DSTAT may address overactive inflammatory response including underlying causes of blood coagulation disorders associated with COVID-19.

Chimerix is a development-stage biopharmaceutical company based in Durham, N.C. which is engaged in advancing medicines in the areas of cancer and other serious diseases. The company listed that it presently has two active clinical-stage development programs. The first is dociparstat sodium (DSTAT) which is a glycosaminoglycan compound derived from porcine heparin that has low anticoagulant activity. The second pipeline candidate is brincidofovir (BCV) which is an antiviral drug being developed as a medical countermeasure for smallpox.

Chimerix began the day with a market capitalization of around $93.2 million with approximately 61.74 million shares outstanding. CMRX shares opened 30% higher today at $1.97 (+$0.46, +30.46%) over yesterday's $1.51 closing price. The stock has traded today between $1.82 to $2.62 per share and is currently trading at $2.27 (+$0.76, +50.33%).

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: CMRX:NASDAQ, )

Source: Streetwise Reports   05/01/2020

Seattle Genetics Inc. (SGEN:NASDAQ) yesterday announced financial results for the first quarter ended March 31, 2020.

The company also provided an update on commercial results achieved in the quarter for its lead medicines including ADCETRIS® (brentuximab vedotin) and PADCEV^™ (enfortumab vedotin-ejfv) and the U.S. Food and Drug Administration's (FDA) approval and launch of TUKYSA^™ (tucatinib).

The company's President and CEO Clay Siegall, Ph.D., commented, "We have had a remarkable start to 2020, delivering record product sales in the first quarter that are now coming from both ADCETRIS and PADCEV. Notably, strong PADCEV sales in the first full quarter of launch reflect the unmet need among patients with metastatic bladder cancer...With the recent approval of TUKYSA for patients with metastatic HER2-positive breast cancer, we have now launched our third product just four months after our second...We are also preparing for European commercial operations and have hired general managers in major European markets ahead of potential ex-U.S. approvals of TUKYSA. With two new products, growing revenues, and an advancing pipeline of novel cancer programs, we have exciting prospects for future growth."

The company highlighted that ADCETRIS net sales in the U.S. and Canada increased by 22% to $164.1 million in Q1/20, compared to $135 million in Q1/19. The firm indicated that PADCEV net sales in the U.S. reached $34.5 million in Q1/20, which was its first full quarter of commercialization. The company added that royalty revenues in Q1/20 were $20.4 million and collaboration and license agreement revenues in Q1/20 totaled $15.6 million.

The firm reported a net loss for Q1/20 of $168.4 million, or $0.98 per diluted share, compared to net loss of $13.3 million, or $0.08 per diluted share for Q1/19. The company explained that "the net loss in Q1/20 included a net investment loss of $59.1 million primarily associated with its common stock holdings in Immunomedics, which are marked-to-market, compared to a net investment gain of $38.1 million in Q1/19."

The company advised that its TUKYSA was approved by the FDA for patients with HER2-positive metastatic breast cancer who have received one or more prior anti-HER2 regimens in the metastatic setting. The firm mentioned that it also expects to be able to report topline data in late Q2/20 or Q3/20 for the innovaTV 204 pivotal trial of tisotumab vedotin in patients with recurrent and/or metastatic cervical cancer who have relapsed or progressed after standard of care treatment.

The company noted that it is regularly monitoring the effects of the COVID-19 situation and is maintaining its business outlook estimates for FY/20 that it provided previously on February 6, 2020. For FY/20 it expects ADCETRIS net product sales of $675–700 million, royalty revenues of $105–115 million and collaboration and license agreement revenues of $30–50 million. The firm advised that for FY/20 it expects that R&D expenses will range from $860–950 million with SG&A expenses of $475–525 million.

Seattle Genetics is headquartered in Bothell, Wash., and is a global biotechnology company focused on discovering and commercializing cancer medicines.

Seattle Genetics has a market capitalization of around $23.7 billion with approximately 172.5 million shares outstanding. SGEN shares opened 2.75% higher today at $141.00 (+$3.77, +2.75%) over yesterday's $137.23 closing price and reached a new 52-week high price this morning of $157.00. The stock has traded today between $140.05 and $157.00 per share and is currently trading at $148.51 (+$11.28, +8.22%).

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: SGEN:NASDAQ, )

Source: Streetwise Reports   05/04/2020

Stemline Therapeutics Inc. (STML:NASDAQ), which is focused on developing and commercializing novel oncology therapeutics, today announced that it has entered into a definitive agreement to be acquired by private Italian pharmaceutical and diagnostics company Menarini Group in a transaction valued up to $677 million.

The companies advised that the transaction has already been unanimously approved by both companies' Boards of Directors and that the transaction is expected to close in Q2/20 subject to customary closing conditions, regulatory approvals and a tender of at least 50% of the outstanding Stemline shares by shareholders. Menarini stated that it plans to fund the purchase by using existing cash resources.

The firms outlined that purchase details and advised that "under the terms of the agreement, a wholly owned subsidiary of the Menarini Group will commence a tender offer for all outstanding shares of Stemline, whereby Stemline shareholders will be offered a total potential consideration of $12.50 per share, consisting of an upfront payment of $11.50 in cash and one non-tradeable Contingent Value Right (CVR) that will entitle each holder to an additional $1.00 in cash per share upon completion of the first sale of ELZONRIS in any EU5 country after European Commission approval."

The report explained that ELZONRIS is a novel targeted therapy directed to the interleukin-3 (IL-3) receptor-α (CD123) and was developed by Stemline for treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adult and pediatric patients. The firm stated that the U.S. Food and Drug Administration (FDA) approved that drug in the U.S. in December 2018. A marketing authorization application (MAA) has already been submitted and is presently under review by the European Medicines Agency. Post acquisition, Menarini expects to obtain approvals and expand distribution of ELZONRIS to Europe and emerging markets.

Stemline Therapeutics' Chairman, CEO and Founder Ivan Bergstein, M.D., commented, "Joining Menarini represents a unique opportunity for Stemline to advance the commercialization of ELZONRIS across the globe and to accelerate the development of our pipeline of oncology assets. ...We are excited to be combining with a like-minded organization in Menarini, in a transaction that will deliver immediate and significant cash value to our shareholders, while also allowing our shareholders to participate in the future upside of ELZONRIS's European launch."

Elcin Barker Ergun, CEO of Menarini Group, remarked, "Stemline is an excellent fit for Menarini, enabling us to expand our presence in the U.S. with an established biopharmaceutical company focused on developing oncology therapeutics. Through this acquisition, we will continue to strengthen our portfolio and pipeline of oncology assets and deliver novel therapies around the world."

The company described BPDCN, formerly blastic NK-cell lymphoma, as "an aggressive hematologic malignancy, often with cutaneous manifestations, with historically poor outcomes which typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera."

Stemline Therapeutics is a commercial-stage biopharmaceutical company headquartered in New York that develops and markets oncology therapeutics. The firm stated that its "ELZONRIS^® (tagraxofusp) is a targeted therapy directed to CD123 and is FDA-approved and commercially available in the U.S. for the treatment of adult and pediatric patients, two years and older, with BPDCN." Stemline noted that ELZONRIS is also being currently being evaluated in clinical studies for other indications including chronic myelomonocytic leukemia, myelofibrosis and acute myeloid leukemia.

The Menarini Group is an international pharmaceutical company based in Italy which operates and sells its products in more than 100 countries. The company stated that it has $4.2 billion in sales annually. The company's medicines address many areas of illnesses including cardiovascular, gastroenterology, metabolic, infectious diseases and anti-inflammatory/analgesic therapeutic areas and oncology.

Stemline Therapeutics began the day with a market capitalization of around $249.2 million with approximately 54.27 million shares outstanding and a short interest of about 11.3%. STML shares opened nearly 150% higher today at $11.81 (+$7.06, +148.63%) over Friday's closing price of $4.75. The stock has traded today between $1.81 and $12.35 per share and is currently trading at $12.10 (+$7.35, +154.74%).

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: STML:NASDAQ, )

Source: Streetwise Reports   05/06/2020

Biopharmaceutical company Horizon Therapeutics Inc. (HZNP:NASDAQ), which focuses on developing and commercializing medicines for treatment of rare and rheumatic diseases, today announced its Q1/20 financial results for the period ending March 31, 2020. The firm began by advising that it is raising its FY/20 net sales guidance and revised its adjusted EBITDA guidance.

For Q1/20 the company reported that net sales increased by 27% to $355.9 million over Q1/19. The firm provided a breakdown of revenue by business unit and listed that in Q1/20 compared with Q1/19, its Orphan segment net sales increased 47% to $245.4 Million, KRYSTEXXA® net sales rose by 78% to $93.3 million and TEPEZZA (teprotumumab-trbw) net sales were $23.5 million, which exceeded expectations.

The firm advised that it is increasing FY/20 net sales guidance to $1.40-1.45 billion driven primarily by significantly higher TEPEZZA net sales and reflecting anticipated impacts from COVID-19. The company also presented revised FY/20 adjusted EBITDA guidance of $450-500 million, which reflects increased TEPEZZA program investment to support higher-than-expected demand.

The firm indicated that in Q1/20 it posted a GAAP net loss of $13.6 million with adjusted EBITDA of $107.2 million and non-GAAP net income of $83.2 million.

The company's Chairman, President and CEO Timothy Walbert commented, "We had a very strong start to 2020, highlighted by the early approval and rapid uptake of TEPEZZA, which significantly exceeded expectations, excellent KRYSTEXXA growth and our recent acquisition of HZN-825...We are increasing our full-year net sales guidance to account for significantly higher TEPEZZA net sales that more than offset the expected impact from COVID-19 this year, and we are widening both our net sales and adjusted EBITDA guidance ranges to account for future uncertainty. The fundamentals of our business are strong, including a robust cash position, and we continue to be very well positioned for the long term."

The company noted that it received FDA approval for TEPEZZA for the treatment of thyroid eye disease (TED) earlier this year in January. The firm described TED as "a rare, serious, progressive and vision-threatening autoimmune disease, and is associated with proptosis (eye bulging), diplopia (double vision), blurred vision, pain and facial disfigurement." The company further s explained that "TEPEZZA, a fully human monoclonal antibody insulin-like growth factor-1 receptor (IGF-1R) inhibitor, is the first and only FDA-approved medicine for the treatment of TED."

Horizon Therapeutics is a biopharmaceutical company headquartered in Dublin, Ireland. The firm researches, develops and commercializes medicines for treatment of rare and rheumatic diseases.

Horizon has a market capitalization of around $7.1 billion with approximately 190.2 million shares outstanding and a short interest of about 4.9%. HZNP shares opened 10% higher today at $44.19 (+$3.81, +10.19%) over yesterday's $37.38 closing price and reached a new 52-week high price this morning of $43.57. The stock has traded today between $40.00 and $43.90 per share and is currently trading at $42.95 (+$5.57, +14.90%).

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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Hispanic Mexican city of Teotihuacan may have bred rabbits and hares for food, fur and bone tools, according to a study published August 17, 2016 in the open-access journal PLOS ONE by Andrew Somerville from the University of California San Diego, US, and colleagues.

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Ensuring successful public engagement in policy can be difficult. Four key challenges – communicating complexity, providing balanced information, creating space for deliberation and accessing broader values – are highlighted by a new study. Its authors show how they dealt with these challenges in a UK programme, designed to gather public views on the future of national energy policy.

Astronomers using ESO telescopes and other facilities have found clear evidence of a planet orbiting the closest star to Earth, Proxima Centauri. The long-sought world, designated Proxima b, orbits its cool red parent star every 11 days and has a temperature suitable for liquid water to exist on its surface. This rocky world is a little more massive than the Earth and is the closest exoplanet to us -- and it may also be the closest possible abode for life outside the Solar System. A paper describing this milestone finding will be published in the journal Nature on 25 August 2016.

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It is possible to balance agricultural production with improved biodiversity on farmland, according to researchers. A new study suggests using a combination of land sharing techniques, which enhance biodiversity on existing farmland, with land separation techniques, which designate separate areas for conservation and farmland production.

The Football Association has declared all non-league divisions from steps three to six of the football pyramid null and void, as well as tiers three to seven of the women's league, after all divisions were postponed due to the coronavirus outbreak.

While the company has pushed to transition into an oil explorer, that move could prove pointless after crude's historic crash.

NPR radio host Scott Simon has been touching people across the country by tweeting from his mother’s deathbed in a Chicago hospital.

Meet the author, farmer, entrepreneur and leader of the local food movement as he shares his thoughts on modern farming and the needs of animals.

A 30-week Urban Farm School program begins on April 1 at the Ashevillage Institute and Sanctuary in North Carolina.

Some have compared the Typhoon Haiyan's devastation to the mayhem caused by the 2004 Indian Ocean tsunami.

Customers will be able to learn more about the environmental impact of their mobile devices.

Seven species of Hawaiian pollinators are the first bees added to the U.S. endangered species list — but they're unlikely to be the last.

When your head hits the pillow at night, do creatures lurk? See how much your know about terrifying dreams.

A Product Impact Dashboard tells you exactly how much rubbish was used to create Pentatonic's cushions, tables and serving bowls.

The '99 Days of Freedom' project has launched an experiment promoting happiness by helping users give up the social networking site.

A note-perfect 'clean coal' parody site has become the talk of the Internet. With its Coal Cares campaign, the heretofore unknown activist group Coal is Killing

From curious kid to giving back, to advisor to Apple computers, Jackson shares her path to leadership.

Australia, on track to eliminate 2 million feral cats by 2020, bans outdoor cats.

During an Energy and Natural Resources Committee hearing, the secretary of the Interior outlines the Obama administration's energy wish list.

Roughly 20 million Americans work from home on at least a semi-regular basis. Here's how telecommuting is impressive dent in carbon emissions — and what you

With her delicious and healthy products in the store, Mary Waldner shares her rise to success, how she eats at home, and advice to us all in how to enjoy a heal

Makower, one of the most respected voices in green business, talks about greener corporations, what the government could be doing to foster more environmentally

Scientists hope a new vaccination campaign will give Ethiopian wolves a fighting chance at survival.

Homemade aromatherapy shower squares can help relieve stress and even allergies. Here's how to make them yourself.

Scientists and artists have more in common than one might think. Many techniques used by artists are just as indispensable for scientists, who use interesting i

Custom colors haven't always been as easy to come by as they are today. In the past they came from insects, mummies and heavy metals around the world.

The creepy bodark tree produces unnervingly strange fruit.

Thanks to an abundance of beech seeds, so far this year 150 orange-fronted parakeet chicks have been born in the wild in New Zealand.

Long feared extinct, the extremely rare Omura's whale was recorded by a team of biologists off the coast of Madagascar.

The former V.P. says global warming doubters will one day be seen similarly to racists, and urges people who support emissions cuts to 'win the conversation.'

Regulator seeks court action to resolve uncertainty on business interruption cover and bring clarity on specific policy clauses.

An impressive interview with an impressive drummer Mike Aresco of Dead Skin Mask and formerly Of Lost Soul.(updated version)

Mr. Fares' company, Celitech Inc., won recognition as the "Overall Wireless Broadband Solution of the Year" by the Mobile Breakthrough Awards Program in 2019.