Amag Pharmaceuticals price target raised to $14 from $10 at H.C. Wainwright » 11:0608/0608/06/20
H.C. Wainwright analyst…
H.C. Wainwright analyst Douglas Tsao raised the firm's price target on Amag Pharmaceuticals to $14 from $10 and keeps a Buy rating on the shares. While the company reported a "mixed" quarter, "all signs point to a turnaround" and the company is now guiding to EBITDA profitability in the second half, said Tsao. The analyst has been impressed by the speed with which CEO Scott Myers has been able to implement change and likes the renewed focus on driving Feraheme into new indications and developing ciraparantag, Tsao added.
Piper says avoid Amag as turnaround remains 'tall order' » 10:3808/0608/06/20
Piper Sandler analyst…
Piper Sandler analyst Christoper Raymond raised the firm's price target on Amag Pharmaceuticals to $8 from $7 and keeps an Underweight rating on the shares. The analyst left the company's Q2 earnings call "feeling incrementally positive" about CEO Scott Myers. However, with Makena still facing a potential market withdrawal, Feraheme disproportionately impacted by COVID-19, a "relatively important" pipeline failure with AMAG-423 for preeclampsia, and disclosed accounting errors around historical Makena revenue reporting, Amge's turnaround "remains a tall order, especially with a sizeable convert coming due in 2022," Raymond tells investors in a research note titled "Love The New Approach But Sins of the Past Have Dug a Big Hole." As such, the analyst continues to urge investors to avoid the stock.
Amag finds 'immaterial errors' in Makena revenue from 2016 to 2020 » 10:3708/0608/06/20
Amag Pharmaceuticals said…
Amag Pharmaceuticals said earlier in its earnings release, "The financial figures and statements referenced herein have been adjusted to correct immaterial errors in Makena revenue in the historical periods 2016 through the first quarter of 2020; in aggregate, Makena revenue is reduced by $6.3 million over the four-year period. This error was identified by the company during the second quarter of 2020 and relates to the timely accrual of certain governmental rebates. The company and our independent auditors are still reviewing the prior period financial statements and the potential impact on our internal controls over financial reporting for the periods. Therefore, the financials set forth in this release are preliminary and may be updated in the company's quarterly report on Form 10Q for the quarter ended June 30, 2020. As a result, investors are cautioned not to place undue reliance on these financial statements."
Amag stops AMAG-423 study in preeclampsia after DSMB recommendation » 10:3508/0608/06/20
Amag Pharmaceuticals announced this morning that following an analysis, the Data and Safety Monitoring Board provided a unanimous recommendation to stop the AMAG-423 Phase 2b/3a study, based upon the low likelihood that future enrollment would demonstrate a benefit in women with severe preeclampsia. Amag has accepted the DSMB's recommendation to stop the study "and is currently focused on ensuring an appropriate closeout of the study in partnership with investigators and other relevant stakeholders."
Amag Pharmaceuticals sees FY20 revenue view $225M-$255M, consensus $250.01M » 07:0908/0608/06/20
"Strong execution across our portfolio throughout the COVID-19 pandemic allows us to reissue financial guidance that reflects the relative stability of Makena over the quarter and the momentum that Feraheme began to build in June, which saw record highs in monthly share and ex-factory volume," said Brian Piekos, Chief Financial Officer. "The guidance we are sharing today is designed to prioritize investments that will drive long-term growth while also putting us on track to return to positive adjusted EBITDA."
Amag Pharmaceuticals reports Q2 EPS (39c), consensus (19c) » 07:0808/0608/06/20
Reports Q2 revenue…
Reports Q2 revenue $52.8M, consensus $57.95M. "Amidst the unprecedented uncertainty that COVID-19 placed on the healthcare system and our economy, AMAG's marketed therapeutics performed well in the second quarter due in part to our teams' ability to adapt in a rapidly-changing environment," said Scott Myers, AMAG's Chief Executive Officer. "Over the past three months, we have advanced the company's strategic evolution by reaching important milestones that include a strategic, ex-US partnership with Norgine to further progress ciraparantag and strengthen our company's ability to invest in our pipeline. We have also streamlined expenses by completing the divestment of Intrarosa and Vyleesi and making changes to our portfolio designed to further focus on programs with the highest potential to deliver innovative treatments for patients and unlock shareholder value."
Palatin completes enrollment in Phase 2 Study with PL9643 » 07:3608/0508/05/20
Palatin Technologies announced completion of enrollment of its Phase 2 study with PL9643 for the treatment of dry eye disease. After delaying enrollment of new patient groups due to the COVID-19 pandemic, Palatin reinitiated enrollment in its PL9643 Phase 2 clinical study in subjects with dry eye disease last month. With enrollment completed, data readout is targeted for the fourth quarter of calendar year 2020.
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Agreement termination 'optimal' for Vyleesi future, says H.C. Wainwright » 10:1607/2707/27/20
PTN, AMAG, PFE, ABBV, MRK
H.C. Wainwright analyst…
H.C. Wainwright analyst Joseph Pantginis notes that Palatin (PTN) and Amag Pharmaceuticals (AMAG) announced the mutual termination of the license agreement for Vyleesi in North America, with Palatin retaining all North American and development and commercialization rights. The analyst believes that a major point for investors to focus on is that Amag's launch of the drug was essentially aborted because of its change of strategy before a market for Vyleesi could be established. The launch was still in the early stages of broad sampling. Instead of Amag licensing Vyleesi to someone else, Pantginis believes this is the optimal next step for the drug's future, as it gives Palatin important freedom to operate now, including finding the best potential partnership possible. Management indicated that all options are now on the table, which could range from North America again to broader geographic deals, he adds. Pantginis believes that Pfizer (PFE), AbbVie (ABBV), and Merck (MRK) could be relevant targets for partnering. Further, it would be surprising to him if Palatin had not already begun discussions with these companies prior to partnering with Amag. He has a Buy rating and a price target of $2 on Palatin's shares.
Amag Pharmaceuticals, Palatin mutually terminate 2017 license agreement » 07:3907/2707/27/20
AMAG Pharmaceuticals announced AMAG and Palatin Technologies have mutually terminated the January 2017 license agreement pursuant to which AMAG was granted exclusive rights to develop and commercialize Vyleesi, a melanocortin receptor agonist indicated for the treatment of acquired, generalized hypoactive sexual desire disorder in premenopausal women, in North America. Under the terms of the termination agreement, all of AMAG's rights and obligations to develop and commercialize Vyleesi under the license agreement will terminate, and full ownership of Vyleesi will transfer back to Palatin. AMAG will pay Palatin $12M at closing and $4.3M on March 31, 2021. In exchange for such payments, Palatin will assume all Vyleesi manufacturing agreements and associated minimum commitments and AMAG will transfer to Palatin all data and assets related exclusively to Vyleesi. Under the agreement, Palatin has agreed to compensate AMAG to provide certain transitional services to Palatin for a period of time to ensure continued patient access to Vyleesi during the transition back to Palatin.
Palatin and AMAG terminate license agreement for Vyleesi » 07:0207/2707/27/20
Palatin Technologies announced that it has mutually terminated the January 2017 license agreement which granted AMAG Pharmaceuticals exclusive North American rights to market Vyleesi, the first and only on demand treatment for pre-menopausal women suffering from acquired, generalized, hypoactive sexual desire disorder (HSDD), a condition affecting one in ten premenopausal women. Under the terms of the termination agreement, Palatin will regain all North American development and commercialization rights for Vyleesi. AMAG will make a $12M payment to Palatin at closing and a $4.3M million payment to Palatin on March 31, 2021. Palatin will assume all Vyleesi manufacturing agreements, and AMAG will transfer all information, data, and assets related exclusively to Vyleesi, including, but not limited to, existing inventory. AMAG will provide certain transitional services to Palatin for a period of time to ensure continued patient access to Vyleesi during the transition back to Palatin. Palatin will reimburse AMAG for the costs of the transition services.