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Thursday, February 13, 2020

Could U.S. ICUs Handle 45,000-Bed Coronavirus Load?

In 2009, I was staffing an intensive care unit where 10 of the first 40 confirmed cases of a novel influenza A (H1N1) ended up as patients in our ICU. Everyone was mechanically ventilated, three ended up on ECMO, or extracorporeal life support. I can’t recall who lived and who died. I can recall the feeling that if H1N1 was to have a 25% ICU admission rate, our healthcare system would quickly be overrun.
As an ICU doctor, I am not interested that much in pandemics. My focus is on the patient in front of me and how they will manage. ICU care is a team game and apart from me, critically ill patients require materials and people to create a chance at survival. This has been a bad flu season, and we have a steady diet of sick flu patients, all seemingly unvaccinated, that have kept up our steady ECMO business.
A recent paper described 138 hospitalized patients with novel coronavirus infection in a single hospital in Wuhan, China, claiming an ICU admission rate of 26% and a mortality rate of 4.3%. Upon review, it appears that the overall mortality rate is about 2%-3%. Based on these numbers and additional information, we can create a model for a worst-case scenario here in the U.S.
Let’s assume the total number of cases of novel coronavirus to be 18,000 at the time of this published series, with 138 patients admitted to a single hospital. This corresponds to a 0.76% hospital admission rate. The population of the U.S. in 2020 is estimated to be 331 million. Let’s assume that 10% of the entire population of the U.S. contracts coronavirus, the same rate as the annual influenza infection prevalence.
If we assume a 1% hospital admission rate, that would correspond to roughly 300,000 patients admitted to hospitals. If we assume 25% of those admitted patients end up in an ICU, that corresponds to 75,000 patients.
According to the American Heart Association annual survey in 2015, the U.S. had 4,862 acute care registered hospitals and 94,837 ICU beds with a 68% ICU occupancy rate. My own experience is that ICU occupancy rate is more than 80% but let’s assume 70% occupancy. If we assume the total number of ICU beds in the U.S. is 100,000, this corresponds to an available bed rate of 30,000. This means 45,000 patients over and above the available ICU bed rate.
Imagine now a 20-bed unit with five open beds under normal circumstances and instead, you need 10 beds. To add five beds, you need a physical place to add them, including all of the equipment and all of the staff. You will need roughly 10 nurses to staff these new beds or an additional 60,000 nurses around the country.
An ICU room costs about $400 per square foot to build and the room size should be at least 250 square feet. This corresponds to each new ICU bed costing $100,000.
So adding 45,000 new beds to the U.S. healthcare infrastructure would therefore cost $450 million.
These 45,000 new beds would need to be staffed by new or existing ICU physicians, pharmacists, respiratory therapists, dietitians, physical therapists, and occupational therapists, and supported by additional medical specialists including a variety of medical and surgical specialties.
Coronavirus management will be impacted by benefits and liabilities. It is not a mass casualty event and hospitals won’t likely need to face the prospect of many patients at one time. An ICU patient has various trajectories. In an ICU stay, the day associated with the highest mortality is the day of admission. To be frank, a dead patient does not consume resources and some patients will be transferred to the ICU and not need ECMO.
The liability here is not only the rate of rise of new cases but also the number of healthcare workers that become ill. If many healthcare workers fall ill, this will impact the healthcare workforce in negative ways. A mass casualty event does not generally sicken the healthcare worker, but coronavirus has killed at least one physician in Wuhan.
What is our reasonable response to novel coronavirus? A vaccine for this virus might be years away and the occurrence rate appears to be increasing in more than linear fashion. Our response will depend on the actual rate of transmission and our ability to control the spread here in the U.S.
I can only manage the patient in front of me. In order to combat coronavirus, we may need coordination and cooperation much beyond what we currently achieve.
Joel Zivot, MD, is at Emory University School of Medicine in Atlanta. His clinical expertise and research interests include care of critically ill patients in the OR and ICU, education, and scholarly work in bioethics, the anthropology of conflict resolution, pharmaco-economics, and a variety of topics related to anesthesiology/critical care monitoring and practice.
https://www.medpagetoday.com/hospitalbasedmedicine/generalhospitalpractice/84845

Indivior posts steep quarterly loss as copycat drugs bite

Indivior reported a fourth-quarter loss on Thursday and forecast a further drop in sales this year as the drugmaker grapples with a series of legal defeats related to its top opioid addiction treatment, sending its shares down as much as 22%.

The company’s Suboxone has been among the main treatments for addiction through a growing epidemic of opioid abuse in the United States. A film variant of Suboxone has lost more than half its market share to cheaper rivals in the last year.
Indivior’s shares have also plunged, by nearly two-thirds in 2019, as it also battles a potentially crushing $3 billion (£2.3 billion) fine for illegally marketing Suboxone. The market share for branded Suboxone film was 24% at the end of last year, down from a 53% share at the end of 2018.
Indivior, which gets the bulk of its sales from the United States, has gained from the government’s efforts to combat the opioid epidemic and is focusing on newer drugs such as Sublocade, an injectable treatment, to boost sales.
The company, which also took a hit from higher marketing costs promoting Sublocade, said the new treatment’s sales in 2020 were expected to be between $150 million and $200 million, while the company’s total sales are expected to be in a range of $525 million to $585 million.
“Although we are optimistic about delivering on our strategic priorities in 2020, we of course recognise the legal uncertainties we face,” Chief Executive Officer Shaun Thaxter said.
Indivior last year was indicted and accused of deceiving doctors and healthcare benefit programs in the United States into believing its Suboxone film, itself a form of opioid, was safer and less susceptible to abuse than similar drugs.
The company, spun-off from Reckitt Benckiser in 2014, said net loss was $55 million for the three months ended Dec. 31, compared to a profit of $24 million a year earlier.
Indivior’s shares were down nearly 20% at 39.41 pence as at 0816 GMT and was the biggest loser on Britain’s small-cap index.
https://www.marketscreener.com/INDIVIOR-19344116/news/Indivior-posts-steep-quarterly-loss-as-copycat-drugs-bite-shares-plunge-29990563/

Ipsen Presents ’19 Results, ’20 Guidance, Updated ’22 Financial Outlook

Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, today announced its financial results for the full year 2019.
  • Group sales growth of 15.8% as reported or 14.8% at constant currency and scope of consolidation1, driven by Specialty Care sales growth of 17.2%1, reflecting strong performance across all major products and geographies, while Consumer Healthcare sales were down -1.2%1
  • Core Operating margin at 30.4% of net sales, up 0.7 points. IFRS Operating margin at -1.3% of net sales, down 24.6 points
  • Setback in the palovarotene program of partial clinical hold for all patients under 14 years of age and reaching pre-specified second interim analysis futility criteria in the Phase 3 MOVE trial for fibrodysplasia ossificans progressiva (FOP), leading to a partial impairment of €669 million before tax
  • Core consolidated net profit of €563 million (+14.6% vs. 2018), with fully diluted Core EPS growing by 14.1% to reach €6.74. IFRS Consolidated net profit showing a loss of €50 million, with an IFRS net loss per share of €0.61
  • Sound financial structure, with a closing Net Debt of €1,116 million and a Net Debt to EBITDA ratio at 1.3x. Strong Free Cash Flow at €468 million, up 2%, mainly driven by higher Operating Cash Flow.
  • Continued commitment to disciplined execution of business development strategy for long-term sustainability focusing on the Group’s core therapeutic areas (Oncology, Neuroscience, Rare Diseases) and across different transaction structures and various phases of drug development
  • Advancing solid pipeline with several significant new chemical entities and Phase 3 / registrational trials, including the initiation of pivotal Phase 3 trials for Onivyde® in 1L Pancreatic Ductal Adenocarcinoma (PDAC) and 2L Small Cell Lung Cancer (SCLC) and upcoming top-line results for the Phase 3 trial of Cabometyx® in combination with nivolumab in 1L Renal Cell Carcinoma (RCC)
  • Proposed distribution of €1.00 per share2 for the 2019 financial year, consistent with the prior year
  • 2020 guidance3 of Group sales growth greater than +6.0% at constant currency and Core Operating margin around 30.0% of net sales
  • Updated 2022 outlook3 with Group sales greater than €2.8 billion and Core Operating margin greater than 28.0% of net sales
Aymeric Le Chatelier, Chief Executive Officer and Chief Financial Officer of Ipsen, stated: “2019 was another excellent year of operating performance for Ipsen with continued double-digit top-line growth and core operating margin expansion. Despite the recent palovarotene setback, the fundamentals of our business remain strong with a growing Specialty Care franchise and a sound financial structure including attractive cash flow generation. We are committed to the disciplined execution of our strategy, delivering solid mid-single digit growth in 2020 and further advancing our R&D pipeline programs. We have also updated our 2022 outlook taking into account the latest developments in the current business. We remain focused on executing our internal and external R&D strategy to strengthen our pipeline and deliver sustainable growth for years to come.”
_______________________
1 Year-on-year growth excluding foreign exchange impact established by recalculating net sales for the relevant period at the rate used for the previous period. Sales [2]growth adjusted for consolidation scope including: subsidiaries involved in the partnership between Ipsen and Schwabe Group consolidated in accordance with the equity method since 1 January 2019; and 2018 Etiasa® (mesalazine) sales adjusted for the new contractual set up.
2 Decided by the Ipsen S.A. Board of Directors, which met on 12 February 2020, to propose at the Annual Shareholders’ meeting on 2 May 2020.
3 Assuming no impact of new somatostatin analog (SSA) generic entry in 2020 and excluding impact of incremental investments in pipeline expansion initiatives
Review of full year 2019 results
Extract of audited consolidated results for the full year 2019 and 2018
(in million euros) FY 2019 FY 2018 % change % change at constant currency
and scope1
Group net sales 2,576.2 2,224.8 +15.8% +14.8%
Specialty Care sales 2,299.4 1,924.5 +19.5% +17.2%
Consumer Healthcare sales 276.8 300.3 -7.8% -1.2%





CORE



Core Operating Income 782.6 659.9 +18.6%
Core Operating margin (as a % net sales) 30.4% 29.7% +0.7 pts
Core consolidated net profit 563.4 491.6 +14.6%
Core EPS – fully diluted (€) 6.74 5.91 +14.1%





IFRS



Operating Income (33.4) 519.4 -106.4%
Operating margin (as a % net sales) -1.3% 23.3% -24.6 pts
Consolidated net profit (50.2) 389.1 -112.9%
EPS – fully diluted (€) (0.61) 4.68 -113.0%
Group net sales reached €2,576.2 million, up 14.8%1 year-on-year.
Specialty Care sales reached €2,299.4 million, up 17.2%1, driven by the continued strong growth of Somatuline® (lanreotide) and the €376.9 million contribution from the key Oncology launches of Cabometyx® (cabozantinib) and Onivyde® (irinotecan liposome injection). Somatuline growth of 18.3%1 was driven by continued positive momentum in North America (21.3%) and solid performance throughout Europe, including Germany. Dysport® (botulinum toxin type A) growth was fueled by good performance in the therapeutics and in the aesthetics markets. Decapeptyl® (triptorelin) sales reflect good volume growth across Major European countries and in Southeast Asia.
Consumer Healthcare sales reached €276.8 million, down -1.2%1, due to a decline in Smecta® (diosmectite) sales, especially in China.
Core Operating Income reached €782.6 million in 2019, compared to €659.9 million in 2018, a growth of 18.6%, driven by the sales growth and after increased R&D investments to support the development of the growing pipeline.
Core Operating margin reached 30.4% of net sales, up 0.7 points compared to 2018.
Core consolidated net profit was €563.4 million in 2019, an increase of 14.6% versus €491.6 million in 2018, driven by higher Core Operating Income compensated by increased net financial costs, notably related to higher net debt from the Clementia acquisition.
Fully diluted Core earnings per share grew by 14.1% to reach €6.74, compared to €5.91 in 2018.
IFRS Operating Income was a loss of €33.4 million, mainly due to an impairment charge of €668.8 million on the intangible assets of palovarotene. IFRS operating margin of -1.3% was down 24.6 points compared to 2018.
IFRS Consolidated net profit was a loss of €50.2 million due to financial expenses resulting from the Onivyde contingent payment reevaluation, financing costs and income tax for a total of €244.8 million, offset by the positive impact on financial result of the revaluation of the Clementia Contingent Value Rights (CVR) and milestones, and on income tax of the tax effect from the palovarotene intangible asset impairment for a total of €220.0 million.
IFRS Fully diluted EPS (Earnings per share) was a net loss per share amounting to €0.61 versus a net profit of €4.68 in 2018.
Free Cash Flow reached €467.7 million, up by €9.3 million, mainly driven by higher Operating Cash Flow partly offset by higher cash out from restructuring costs, financial result and current income tax.
Closing net debt reached €1,115.6 million at the end of 2019, as compared to closing net debt in 2018 of €242.5 million. This reflects the acquisition of Clementia, other business development and milestones, the impact of the application of IFRS16, and the payment of the dividend.
Impairment loss related to palovarotene program
Ipsen recorded a €668.8 million partial impairment, before tax, on the palovarotene intangible assets at December 31, 2019 as a result of the recent developments in the palovarotene development program. This takes into account:
  • 6 December 2019: Following discussions with the U.S. Food and Drug Administration (FDA), a partial clinical hold was issued for patients under the age of 14 for studies evaluating palovarotene for the chronic treatment of fibrodysplasia ossificans progressiva (FOP) and multiple osteochondromas (MO).
  • 24 January 2020: Palovarotene Phase 3 MOVE trial for fibrodysplasia ossificans progressiva (FOP) reached pre-specified second interim analysis futility criteria. Ipsen paused dosing patients in FOP trials taking into consideration IDMC’s recommendation to not discontinue trials based on encouraging therapeutic activity observed in preliminary post-hoc analyses.
Ipsen will continue the development of palovarotene, conduct further assessment of the MOVE dataset, address the FDA questions and define next steps for the clinical program to bring palovarotene to patients as quickly as possible.
Strategy update
During 2019, Ipsen made progress on its journey to being a leading global biopharmaceutical company focused on innovation and Specialty Care.
The three Specialty Care franchises all saw significant progress. The Oncology and Neuroscience franchises continued to demonstrate strong double-digit momentum and despite recent developments with palovarotene, Ipsen remains committed to building a successful Rare Diseases franchise and supporting patients living with FOP. In October 2019, Ipsen in-licensed BLU-782 from Blueprint Medicines, a highly selective ALK2 inhibitor in Phase 1 development for the treatment of FOP.
Ipsen is committed to continuing its business development strategy for long-term sustainability. The strategy will focus on the Group’s core therapeutic areas (Oncology, Neuroscience, Rare Diseases) and across different transactions structures and various phases of drug development. The disciplined execution of this strategy will be supported by the Group’s strong Free Cash Flow generation and close internal collaboration across Ipsen’s teams.
In 2020 and beyond, the Group’s mission to bring innovation to patients remains the same. The priorities and roadmap are clear, and Ipsen continues to execute against its objectives to maximize the portfolio while increasing the value of the pipeline.
Comparison of 2019 performance with financial objectives
The Group exceeded its upgraded guidance provided on 25 July 2019 as shown in the table below:

2019 Financial objectives 2019 Actuals
Group sales growth (at constant exchange rate) > +14.0%1 +14.8%1
Core Operating margin
(as a percentage of sales)
around 30.0% 30.4%
Distribution for the 2019 financial year proposed for the approval of Ipsen’s shareholders
The Ipsen S.A. Board of Directors, which met on 12 February 2020, decided to propose at the Annual Shareholders’ meeting on 29 May 2020 the distribution of €1.00 per share for the 2019 financial year, consistent with the prior year.
2020 Financial guidance
The Group has set the following financial targets for the current year, assuming no impact in 2020 of new somatostatin analog (SSA) generic entry:
Group sales growth year-on-year greater than +6.0% at constant currency; no impact of currency expected based on the current level of exchange rates.
Core Operating margin around 30.0% of net sales, excluding incremental investments in pipeline expansion initiatives.
Updated 2022 Outlook: The Group has updated its 2022 outlook taking into account the latest developments in its current business, mainly in the palovarotene development program:
Group net sales greater than €2.8 billion, assuming current level of exchange rates;
Core Operating margin greater than 28.0% of net sales
The outlook has been updated assuming no approval of additional meaningful products or indications (including no contribution from palovarotene), progressive entry of additional octreotide and lanreotide generics globally from 2021 and excluding the impact of incremental investments in pipeline expansion initiatives.
Conference call
Ipsen will hold a conference call Thursday, 13 February 2020 at 2:30 p.m. (Paris time, GMT+1). Participants should dial in to the call approximately five to ten minutes prior to its start. No reservation is required to participate in the conference call.
Standard International: +44 (0) 2071 928 000
France and continental Europe: +33 (0) 1 76 70 07 94
UK: 08445 718 892
U.S.: (631) 510-7495
Conference ID: 8178467
A recording will be available for seven days on Ipsen’s website
https://www.biospace.com/article/releases/-ipsen-presents-its-2019-results-provides-2020-guidance-and-updates-2022-financial-outlook/

XBiotech down 30% premarket on preliminary results of tender offer

XBiotech (NASDAQ:XBIT) slumps 30% premarket on average volume on the heels of preliminary results from its tender offer announced a month ago.
A total of 41,164,725 common shares were tendered, including 2,178,233 by notice of guaranteed delivery.
It expects to buy ~14M shares at $30 per share for an aggregate of $420M.
The preliminary proration factor for shares the company plans to purchase is ~30.91% which explains the 30% drop in current share price.
https://seekingalpha.com/news/3541726-xbiotech-down-30-premarket-on-preliminary-results-of-tender-offer

Cowen runs through coronavirus impact on airlines

Cowen analyst Helane Becker dissects the coronavirus exposure to select airlines flying to China and Asia-Pacific in general.
America Airlines Group (NASDAQ:AAL) has 2% exposure to China and 3% to APAC.
Delta Air Lines (NYSE:DAL) has 3% exposure to China and 5% to APAC.
United Airlines (NASDAQ:UAL) has 4% exposure to China and 10% to APAC.
Air Canada (OTCQX:ACDVF) has 6% exposure to China and 13% to APAC.
Hawaiian Holdings (NASDAQ:HA) has 0% exposure to China and 26% to APAC.
“Over the next few months, we expect the pandemic to pass, and traffic to China to resume. We expect that by year-end 2020, traffic will be back to a normal pattern,” updates Becker.
https://seekingalpha.com/news/3541735-cowen-runs-through-coronavirus-impact-on-airlines

Indivior PLC ADR reports Q4 results

Indivior PLC ADR (OTCPK:INVVY): Q4 Non-GAAP EPS of -$0.05; GAAP EPS of -$0.08.
Revenue of $133M (-43.6% Y/Y)
https://seekingalpha.com/news/3541500-indivior-plc-adr-reports-q4-results

Ipsen S.A. reports FY results

Ipsen S.A. (OTCPK:IPSEY): FY Non-GAAP EPS of €6.74; GAAP EPS of -€0.61.
Revenue of €2.58B (+16.2% Y/Y)
https://seekingalpha.com/news/3541507-ipsen-s-reports-fy-results