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Startups of the week: Zume Pizza, Carbon Health, Year & Day

When is raising a lot of money bad news?

When the money comes from Saudi Arabia — and comes with questions company executives may not want to answer.

That may be the situation faced by Zume Pizza, a Mountain View company known for delivering hot, fresh pizzas with a lot of tech but not a lot of controversy. It became embroiled in international affairs after a filing with the Securities and Exchange Commission this month revealed that it had raised $375 million. The Wall Street Journal reported that the money came from the SoftBank Vision Fund, a $100 billion tech investing vehicle largely backed by Saudi Arabia.

Silicon Valley firms are debating the ethics of taking money from the Saudis ever since the killing of Jamal Khashoggi, a Washington Post columnist who was critical of Saudi rulers. After initial denials, Saudi officials admitted that the kingdom’s security forces killed Khashoggi in a botched operation.

It is estimated that Saudi Arabia has committed about $45 billion to the Vision Fund. SoftBank has invested in Uber, Nvidia, San Francisco self-driving car developer Cruise and food-delivery startup DoorDash, among many others.

Zume makes pizzas with robots in its kitchen, which finish baking in special trucks while en route to customers, who order through an app. The company, which started delivering pizzas in 2016, has said it’s looking to license its “baked-on-the-way” trucks to restaurants to shake up how food is prepared and delivered.

Zume declined to comment on its funding or answer other questions.

Zume CEO and co-founder Alex Garden has described the company’s trucks in the past as “a fully deployed kitchen.”

Deal of the week: Carbon Health

What it does: Carbon Health combines technology and physical clinics for easier health care delivery.

What happened: It merged with Direct Urgent Care.

Why it matters: The merger gives the company a presence in seven locations around Northern California. Health care is changing fast, with startups like One Medical and Forward redesigning the patient experience.

Headquarters: San Francisco

Funding: Undisclosed

Employees: 1-10 (before merger)

Also trending: Year Day

What it does: Year Day sells tableware directly to consumers online. Its ceramic and glass products and flatware are designed in California and made in Europe.

What happened: It opened a pop-up shop in New York’s SoHo neighborhood.

To hear more

To listen or subscribe on Apple devices:

For other devices, search for “Startups of the Week” in your favorite podcast app.

Why it matters: The company is gaining popularity on Instagram, counting Mandy Moore as a customer and fan. Founder and CEO Kathryn Duryea, who previously worked for Tiffany, said the company offers only a few designs to keep the process of picking out tableware easy. “I really wanted to simplify that decision-making process (of buying tableware) for that customer who is busy, on the go, but always on digitally to help guide them through a process so they could get what they need with confidence,” she said.

Headquarters: San Francisco

Funding: More than $2.5 million

Employees: 5

Sophia Kunthara is a San Francisco Chronicle staff writer. Email: Twitter: @SophiaKunthara

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Lady Gaga details ‘mental health crisis’ and pushes for better care in industry

“I would see flashes of things I was tormented by, experiences that were filed away in my brain with ‘I’ll deal with you later’ for many years because my brain was protecting me, as science teaches us. These were also symptoms of disassociation and PTSD and I did not have a team that included mental health support.”

Lady Gaga in September.

Lady Gaga in September. Credit:AAP

She explained that her struggles “later morphed into physical chronic pain, fibromyalgia, panic attacks, acute trauma responses, and debilitating mental spirals that have included suicidal ideation and masochistic behaviour.”

Gaga, who has been open about being a survivor of sexual assault, suggested that SAG-AFTRA partner with her Born This Way Foundation to implement mental health programs for union members. She even said she would make an unspecified donation to launch the initiative.

“I wish there had been a system in place to protect and guide me, a system in place to empower me to say no to things I felt I had to do, a system in place to empower me to stay away from toxic work environments or working with people who were of seriously questionable character,” Gaga said.

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By Protecting Veterans’ Health, You May Protect Your Own

This Veterans Day, in addition to honoring those who serve in uniform, we should spend some time remembering the 300,000 employees of the Veterans Health Administration. The V.H.A. — the nation’s largest public health system — doesn’t just keep veterans healthy; it has developed treatments that help all Americans. And if we don’t defend it, it could be dismantled and auctioned off in whatever remains of the Trump era.

In V.H.A. facilities I have met some of the best doctors, nurses, therapists and medical researchers I’ve encountered in 40 years of reporting on the hospital industry. They deliver high-quality care to more than nine million patients who are, on average, older, sicker and poorer than those served by other systems. Yet, unlike veterans themselves, who are praised by politicians and the press, V.H.A. staff members, and the agency they work for, are routinely denigrated.

President Trump has insisted that “our veterans have been treated horribly” and that the V.H.A. is staffed with “bad apples” who “rob us or cheat us.” Last month, in a speech at a prestigious medical conference in Cleveland, John Boehner, the former House speaker, said the Department of Veterans Affairs, of which the V.H.A. is part, is simply “hopeless.” Its hospitals “provide substandard care to our veterans who deserve the best care,” Mr. Boehner said. “If you’re a real doctor, you’re probably not working at the V.A.”

Studies have shown that private-sector doctors and hospitals are not prepared to deal with veterans’ complex needs. But foes of the V.H.A., backed by wealthy donors like the Koch brothers, want to dismantle its hospital and clinic network and contract out billions of dollars’ worth of veterans’ services to the private sector.

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OPKO Health’s (OPK) CEO Philip Frost on Q3 2018 Results – Earnings Call Transcript

OPKO Health, Inc (NYSEMKT:OPK) Q3 2018 Earnings Conference Call November 9, 2018 4:15 PM ET


Miriam Miller – LHA Investor Relations

Philip Frost – Chairman and Chief Executive Officer

Steve Rubin – Executive Vice President

Adam Logal – Chief Financial Officer


Sudan Loganathan – Cantor Fitzgerald

Yale Jen – Laidlaw Company


Welcome to the OPKO Health Inc Business Update Conference Call. At this time all participants are in a listen-only mode. Following management’s prepared remarks, we’ll hold a QA session. [Operator Instructions] As a reminder, this conference is being recorded, November 9, 2018.

I would now like to turn the conference over to Miriam Miller. Please go ahead, ma’am.

Miriam Miller

Thank you, operator. Good afternoon. This is Miriam Miller with LHA. Thank you all for joining today’s call. I’d like to remind you that any statements made during this call by management other than statements of historical fact will be considered forward-looking and as such, will be subject to risks and uncertainties that could materially affect the company’s expected results. Those forward-looking statements include, without limitation, the various risks described in the company’s annual report on Form 10-K for the year ended December 31, 2017, and subsequent quarterly report on Form 10-Q.

Importantly, this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, November 9, 2018. Except as required by law, OPKO undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this call.

Before we begin, let me review the format for the call. Dr. Philip Frost, Chairman and Chief Executive Officer, will open the call; followed by Steve Rubin, OPKO’s Executive Vice President, who will provide an update on the company’s various business and clinical programs. After that, Adam Logal, OPKO’s Chief Financial Officer, will review the company’s third quarter financial performance. Dr. Frost will provide closing remarks, and then we’ll open up the call to questions.

Now let me turn the call over to Dr. Frost.

Philip Frost

Good afternoon. I would like to thank everyone for participating in today’s call. The business of our call continues to progress. We have made significant commercial progress as well as with our clinical programs during this past quarter. We have seen month over month growth in RAYALDEE sales throughout 2018. We saw commercial approval for RAYALDEE in Canada through our marketing partner Vifor Fresenius and we initiated a Phase II clinical trial evaluating RAYALDEE in dialysis patients, which opens up the potential for a major expansion beyond the currently approved indication here in the U.S. We also completed enrollment in our Phase III weekly growth hormone trial for the treatment of pediatric growth hormone deficiency. We’re looking forward to continued positive momentum in all aspects of our business.

I will now turn it over to Steve Rubin, who will go into additional detail on our progress.

Steve Rubin

Thank you, Phil. Good afternoon everyone and thank you for joining us today. Before I delve more deeply into the business side of things, I will make some remarks about the SEC complaint filed on September 7, that named both the company and Dr. Frost. Most of you know we had no warning that such a complaint was coming. The SEC did not provide us with a Wells notice or any other indication of its intent to file the action.

We disagree with the SEC’s allegations as we’ve said publicly. We have spent considerable time over the past two months working closely with our advisors to address the allegations in the complaint. We have always prided ourselves on adhering to a high standard of excellence at every level. We are particularly frustrated that this incident has impacted our investors so deeply. Even worse, it came at a time when we were seeing quarter-over-quarter momentum on many fronts.

From improved efficiencies at BRL to impressive prescription growth with RAYALDEE to significant clinical progress across multiple therapeutic candidates. To all of you who have maintained your support of the company, we extend our thanks, and we know it hasn’t been easy. I want to assure you that we are actively working to address the matter. I also want to assure you that the business of OPKO as continued to advance during these challenging times.

Our sales force continues to sell products, our clinical trials continue to enroll patients. BRL and GeneDx continue to make strides. Taken together, this means that we have remained focused on the creation of shareholder value. After we’ve gone through our prepared remarks, we will be opening this call up to your questions, but I ask that you refrain from inquiring about the situation with the SEC.

This is an ongoing legal matter, and as you may realize, we are restricted at what we can say at this time. Also, I’d like to mention the timing of this call and the reporting of our Q3 financial results, both of which are a bit later in our typical practice. This is due to the fact that we were working diligently to secure the additional capital that Adam will be discussing in a moment.

We thank you for patience and for participating in a Friday afternoon call, and we’re happy to have secured $150 million of additional capital. I’ll now turn to the business update including our overall progress towards long-term growth and the achievement of our business goals.

Our clinical diagnostic business, BioReference Laboratories or BRL, is the country’s third largest reference lab. We are pleased to report sequential quarter gains in revenues, a trend we have seen now for the past five quarters. BRL, again, met its revenue goals, and we continue to see both growth and improved efficiency from the lab.

During Q3, Geoff Monk strengthened his team at BRL. We have new leaders and focus in the clinical laboratory space, the complaint space and the service operations space. We have realigned groups to focus on our core needs, and recently added our last executive team member to lead payer relations and marketing.

In the third quarter, GeneDx continued to show strong year-over-year volume growth. Standouts included tests related to neurologic disorders with 42% year-over-year growth. Exome testing also continued to grow well with 35% year-over-year growth. Many GeneDx tests continue to be added and updated as part of our test menu overhaul. Going back to the example of neurologic disorders, new test launch during the third quarter already consistently account for over 10% of total testing volumes within that clinical division. The roadmap over the next six months will continue to yield several more ways of new tests for the next sets of launches including tests for genetic form of pulmonary gastrointestinal, renal and other adult neurologic disorders.

To help drive growth, GeneDx also implemented a series of changes to improve testing ease of use. These included a recently launched easy ordering system within its online ordering portal as well as increased abilities to perform tests sample types. Finally, GeneDx recently made several platform presentations on its findings at the American Society of Human Genetics meeting, one of the largest genetics focused conferences. As part of its collaboration within the UK-based deciphering developmental disorder study and Radboud University medical centre in the Netherlands, a plenary presentation described findings in over 20,000 patients with neurodevelopmental disorders, of which over half were from GeneDx. This collaboration identified over 50 novel disease genes. These findings ensure that GeneDx can maintain superior testing accuracy through its large database of now over 125,000 individuals who have undergone clinical exome or genome sequencing.

Moving on, our 4Kscore blood test gives a man with elevated PSA levels a personalized prediction of his risk of having or developing an aggressive form of prostate cancer. During the third quarter, we processed approximately 18,600 4Kscore tests although volume is down slightly from about 19,000 tests in the comparable quarter of last year. We have been focusing our sales efforts primarily on urologists, which has a short-term impact on the number of tests processed. We’re seeing success as we’ve increased the number of urologists utilized in the test by about 15% for the quarter and continue to see strong retention rate among urologists using the test.

For the trailing 12 months ended September 30, 2018, the total number of 4Kscore tests performed by urologists increased by 19%.

As you know, Novitas released draft non-coverage guidance for the 4Kscore test in May. While the final coverage determination is yet to be made, we remain optimistic it will ultimately go in our favor. Last quarter, we shared with you the work we undertook during the public comment period to demonstrate both the clinical utility and the importance of 4Kscore as an aid to urologists for the diagnosis of the aggressive type of prostate cancer, which requires follow-on treatment.

During this process, Novitas has continued to provide coverage of the 4Kscore to Medicare beneficiaries. Results of five new studies covering the 4Kscore tests were presented at the American Urological Association’s 2018 annual meeting this past May, including a second study demonstrating the 4Kscore tests’ ability to predict prostate cancer mortality in men with elevated PSA.

A study was also presented at the ASCO meeting in June demonstrating the 4Kscore has clinical utility for management decisions of men diagnosed with low and intermediate risk prostate cancer due to its strong associations with radical prostatectomy pathology outcome. We remain focused on driving adoption across target positions and are pleased at the increasing body of evidence that supports its clinical utility.

We have completed a PMA submission to the FDA for our Claros system and a point of care PSA test. This is the first test on our proprietary diagnostic platform that can provide a quantitative blood test result in 10 minutes in the physician’s office with only a finger stick drop of whole blood. We remain on track what we hope will be approval by the FDA early next year.

As I mentioned, Claros 1 is a new platform but we are developing additional tests to interface with our products and programs and expect to submit a 510(k) using the Claros platform to measure testosterone early next year. We are also continuing to work on other biomarkers and biologically meaningful chemistry tests for the platform, including parathyroid hormone and vitamin D.

Turning to our pharmaceuticals division, let me start with RAYALDEE. First and only therapy approved by the FDA that both raises serum total 25-hydroxy vitamin D and lowers parathyroid hormone levels in patients with chronic kidney disease with a safety profile similar to placebo. This has been a big quarter for RAYALDEE. We were pleased to see that Vifor Fresenius was successful in obtaining approval in July to market RAYALDEE in Canada for the treatment of SHPT in adults with Stage 3 or 4 CKD and vitamin D deficiency.

We also announced as promised the initiation of a Phase 2 clinical trial to study the safety and efficacy of RAYALDEE as a new treatment for SHPT in adults with vitamin D insufficiency in Stage 5 CKD requiring hemodialysis. Cost of this study will be shared with our development partner Vifor Fresenius and Japan Tobacco. From a quarterly commercial performance perspective, the RAYALDEE numbers break down as follows. In Q3, the total number of RAYALDEE prescriptions increased approximately 20% versus Q2 and increased 222% versus Q3 of last year.

Importantly, since the launch in 2016, we’ve been seeing steady month-to-month increase in the total number of prescriptions. Our sales team of 64 representatives is demonstrating steadily improving performance as our market penetration continues to grow. 14% of Q3 prescriptions were new to brand and 20% of the prescribers were new to RAYALDEE. We had 1,057 active prescribers in Q3, and this compares with 929 in Q2 and 764 in Q1. Since launch, more than 6,500 unique patients have been prescribed RAYALDEE accounting more than 1.1 million patient days of therapy.

We ended Q2 with RAYALDEE being available to about 79% of the overall insured population with about 52% unrestricted coverage of the Medicare population. With some recent Medicare Part D wins, we expect this number to further increase starting January. RAYALDEE is covered by plans representing some 83% of the commercial population. Overall, we continue to see progress in adoption, reimbursement and awareness of RAYALDEE. Our sales team continues to demonstrate impact, and our market penetration continues to grow.

Regarding our clinical development programs, we remain focused on advancing a diversified portfolio addressing several indications with significant unmet medical need in large markets. We have a robust pipeline of product candidates at varying stages of development, which provides opportunities for creating both near and long-term value for our shareholders.

Starting with our work at renal, as I just mentioned, Vifor Fresenius received marketing approval for RAYALDEE in Canada in late July. They also remain on track to file a market authorization application with the European Medicines Agency by early next year as a trivium for SHPT and CKD patients.

As also mentioned, we initiated a Phase II trial with a higher strength RAYALDEE in patients with Stage 5 CKD and vitamin D insufficiency who require regular dialysis. The first cohort of approximately 44 patients will be treated for 26 weeks in a randomized, open label fashion with either RAYALDEE or placebo to identify the appropriate dosing to be studied in the second cohort. Data readout for this first cohort is expected in 2019.

The second cohort of more than 200 patients will be treated for 26 weeks in a randomized double blind fashion with one of three different doses of RAYALDEE or four placebo. The primary efficacy endpoint will be correction of vitamin D insufficiency and control portfolio SHPT. Patients will then be treated with RAYALDEE for another 26 weeks in an open label extension.

Turning to our metabolic and endocrinology pipeline, we have several late-stage programs underway or nearing initiation. We were pleased to announce in August that we completed enrollment in our global Phase III study in growth hormone deficient children. Our target, which represents more than 80% of the hGH market. It’s a pivotal, non-inferiority study comparing once weekly injection of Somatrogon with daily injections of GENOTROPIN for 12 months.

This pivotal study uses a pen device and formulation intended for commercial launch. We are hopeful that the outcomes will support a dosing change from daily to weekly administration and positively impact the quality of life for children with growth hormone deficiency. We expect to report topline results for this study in Q4 next year. Last fall, we began a pediatric registration study in Japan to assess pharmacokinetics and compare the efficacy of weekly Somatrogon to daily GENOTROPIN in 44 prepubertal growth hormone deficient subjects. We expect to complete enrollment in this study before the end of this year.

Last November, we commenced a Phase IIb dose ranging study with our once daily oral selected androgen receptor modulator or SARM, as the dose finding study in men with BPH or enlarged prostate. This four-month trial is expected to enroll 110 to 120 patients at 30 U.S. sites to identify appropriate safe and effective doses and to assess blood PSA levels, lean body mass and fat mass. We expect to complete enrollment by the end of this year.

In mid-June, we reported that enrollment was complete in our Phase IIb dose escalation trial for our once weekly GLP-1 glucagon dual agonist oxyntomodulin for the treatment of Type 2 diabetes in obesity. This study includes 110 Type 2 diabetics at 35 clinical sites in the U.S. You may recall, we initiated this trial in late March. We are pleased enrollment was completed so quickly – less than three months after trial start. We expect to report findings from the study in the first half of next year. Preclinical and Phase II data show that once weekly dual agonists such as oxyntomodulin can improve glucose control, increase weight loss and improve the lipid profile compared with a GLP-1 therapies currently on the market.

Data from our previous Phase II study with 420 diabetic patients showed greater weight loss compared with the approved, extended release exenatide and placebo. These data also showed improvement in the lipid profile and similar reduction in HbA1c levels compared with the approved once weekly product.

So in closing, we are pleased to announce completion of enrollment in our pediatric hGH program. This represents a significant milestone in our development of this therapeutic. We are also pleased to have completed enrollment in our Phase IIb trial evaluating our oxyntomodulin drug for Type 2 diabetes and weight loss and have initiated a Phase II trial with RAYALDEE in hemodialysis patients. At a high-level, we are advancing a robust clinical development program that addresses several large markets. We expect to continue to make meaningful progress with these programs and to achieve important milestones.

With that overview, let me turn the call over to Adam for discussion of our third quarter financial performance. Adam?

Adam Logal

Thanks, Steve. As we continue to make significant progress on our RD and commercial activities, we also continue to make improvements in our financial performance. We are pleased to report financial results that were in line with the guidance provided during our call in August. Overall, our net loss during the third quarter of 2018 decreased by $8.3 million to $27.7 million or $0.05 per share compared to a net loss of $35.9 million or $0.06 per share for the comparable period of 2017.

Net revenues improved by $3.8 million to $279.8 million for the third quarter 2018, compared to the quarter of 2017, which had $246 million of revenue. Moving to cost and expenses. We have made significant progress in our efforts to improve our operating efficiency. During the third quarter of 2018, we reduced our cost of revenue as well as selling, general and administrative expenses by 8% for almost $20 million compared to the third quarter of 2017. And on a sequential basis, we took out an additional $3 million of cost.

Our investments in RD were $30.2 million for the third quarter of 2018, compared to $32.5 million for the 2017 period. During 2018, RD expense was offset by a $5.3 million related to research and development credits we received in Ireland, which we expect to receive in cash during 2019 related to the construction of our RD center in Waterford, Ireland.

Moving to diagnostics revenues, as Steve mentioned we continue to see improvements in our overall volumes within our clinical laboratory testing and double-digit growth within our genomics testing. On a comparative basis, revenue from services saw its first year-over-year growth since the first quarter of 2017, a trend we’re encouraged by as we continue to see opportunities to regain volumes lost during 2017 and the first half of 2018.

While we will provide a more detailed update for the outlook for 2019 during our year-end call, we are encouraged that our business is stabilized and with the excellent work of the BioReference team, we are positioned for profitable growth in the coming quarters. Improving our cost to serve remains an important focus as the industry will see another year of reimbursement headwind led by the impact of PMA. We remain enthusiastic about the prospects of our GeneDx business and continued volume and overall reimbursement improvement for our efforts to create a sustainable and effective preauthorization and denial management process.

Regarding our pharmaceuticals division’s performance. We recognized $5.8 million of revenue related to the sales of RAYALDEE during the quarter. A 21% increase on a sequential basis from the second quarter of 2018. Based on our current expectations, RAYALDEE’s commercial activities will be cash flow positive during the fourth quarter resulting in further reductions in cash flow used at operations. Total pharmaceutical product revenue for the quarter was $25.4 million compared to $22.8 million for the 2017 period, reflecting the RAYALDEE revenues, partially offset by a decrease in our Latin American revenues.

Revenue related to the transfer of intellectual property during the third quarter of 2018 was $21.6 million compared to $22.4 million for the 2017period. During the third quarter of 2018, we received $8 million from our partners related to the approval of RAYALDEE in Canada as well as a milestone for the commercial – commencement of our Phase II clinical trials in hemodialysis patients. Of these payments, $6 million was deferred and will be recognized over the dialysis development period.

As we announced this afternoon, we have strengthened our balance sheet through a combination of equity and unsecured debt resulting in an additional $150 million of fresh capital, providing us flexibility to execute on our commercial and RD plans. We are fortunate to have the continued financial support of Dr. Frost, Dr. Hsiao and our other long-term investors.

We closed the quarter with approximately $43 million in cash, which, of course, does not include our recent financing. Despite the infusion of capital, we’ll remain mindful our cash balance while we make investments into both our RD pipeline and commercial activities. Improving operating margins and associating cash flow are anticipated to continue within our RAYALDEE and BioReference franchises, and as a result, are expected to reduce our cash flow used in operations.

Looking forward to the fourth quarter, we expect revenues from services to be between $185 million and $205 million. As a reminder, the comparable period of 2017 and revenue from services of $192.7 million after taking into account the adjustment for the adoption of ASC 606 and before nonrecurring adjustments to revenue of $73.3 million consisting of a $30 million payer adjustment and $43 million related to our expected collection amounts.

Turning to product revenues. We expect the fourth quarter to come in between $28 million and $32 million, including revenues from RAYALDEE between $6.5 million and $7.1 million, while the transfer of an intellectual property is expected to be between $18 million and $23 million.

Looking at anticipated expenses for the fourth quarter. We expect costs and expenses to be between $280 million and $290 million, including research and development expense of $33 million to $38 million. We look forward to providing further details on our 2019 financial performance during our year-end update.

With that, I’ll turn the call back to Phil.

Philip Frost

Thanks, Adam. Overall, we were pleased with our progress this past quarter as we advanced sales of our commercial products, continued to work to streamline our BioReference Laboratories unit and to define a urology franchise focused on men’s health. We made significant progress with our clinical programs. We are also pleased to have met our financial guidance for a third consecutive quarter.

At this point, I’d like to express my appreciation to all of our employees for their hard work and dedication to building a great company. Once again, I’d like to thank you all for participating in today’s call. With that, operator, we’re ready to take questions.

Question-and-Answer Session


[Operator Instructions] Our first question is from Louise Chen with Cantor Fitzgerald.

Sudan Loganathan

Thank you so much. This is Sudan Loganathan in for Louise. So I had a few quick questions. So, basically what are the company’s thoughts about the diagnostics business and its performance over the year for the rest of 2018? And then going into 2019, how much room is there left for growth? What’s the company’s plan to extract maximum value for the business? And what are the biggest drivers for growth? And then, regarding the hGH-CTP program, what updates do you have for the remainder of this year? And then what supports your confidence that the pediatric study will be positive?

Adam Logal

This is Adam, I’ll try to jump in on the BioReference side. So certainly, the business is continued to improve throughout the year. We have continued to improve the operating margins, and we do think there is room for our operating margins to improve significantly in 2019. Of course, there’s headwinds in front of us, and we’re still working through our plans. But we are encouraged where Jeff and the team are bringing the business and see great prospects on the pure clinical lab but also within the genomics segment there. So we feel like there is real opportunity to get into the mid double digits – mid-teen – double digits to mid-teen EBITDA margins.

Steve Rubin

For hGH, I mean it’s a blinded study so we’re not going to have a lot of data to talk about – if any data to talk about until we see our topline results. But we obviously feel really good about it, we had very strong Phase II results. Our Phase III is designed – uses one of the dosages we studied in the Phase II. Safety metrics from our open label is continued to be strong, and we’ve had probably more patients on our drug with our ongoing open label Phase II studies than anybody else studying long-acting growth hormone. So we feel probably about as good as you can feel in a blinded clinical study.

Sudan Loganathan

Okay, great. Thank you.


Our next question comes from Yale Jen with Laidlaw Company.

Yale Jen

Good afternoon and thanks for taking the question. We noticed that the third quarter BioReference Lab revenue was slightly lower than the prior quarters and – is there any seasonality toward this? Or there’s other sort of factors that will be depressing the revenue and that that could be a norm going forward?

Adam Logal

So thanks for the question. It’s Adam again. So we – we gave guidance for BioReference to be between $200 million and $220 million during the quarter. Obviously, we came in at the lower end of that range but certainly within where we thought it would be. There’s kind of assumptions around volumes and volume growth and also, I think just across the industry all the other large clinical labs saw some softness in the third quarter. Typically, there’s not a large degree of seasonality, it’s dependent on a number of business days in the quarter and that’s one of the reasons why our fourth quarter is guided between $185 million and $205 million. Just the kind of actual business there.

Yale Jen

Okay. That’s very helpful. And then maybe one more question here, which is that, it seems that your GeneDx operation [indiscernible] revenue side as well as from the new product development side, it seems to both are moving well. So is there a time that eventually you would talk this from a revenue perspective going forward? Or you think that still will blend in the entire BioReference revenue mix?

Adam Logal

Yes. I mean, we manage the business as one, so that’s the reason why we don’t break it out. In the past, we’ve said that it represents between 17% and 20% of the overall revenue. So to give you an indication of where that is. So overall, it’s managed as one business, and we’ll continue to consider it that way.

Yale Jen

Okay. Great. Thanks a lot. That’s really appreciated.

Adam Logal



There are no further questions at this time. Please proceed with your closing presentation.

Philip Frost

Okay. If there are no other questions, we’ll thank you once again for participation, everyone on the call.

Adam Logal

Thank you, Phil.


Ladies and gentlemen that concludes your conference call for today. We thank you for your participation. And ask that you please disconnect your lines.

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Vitamin D And Fish Oil Supplements Disappoint In Long-Awaited Study Results

Taking fish oil supplements to prevent cardiovascular disease and cancer may not be effective.

Cathy Scola/Getty Images

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Cathy Scola/Getty Images

Taking fish oil supplements to prevent cardiovascular disease and cancer may not be effective.

Cathy Scola/Getty Images

Many people routinely take nutritional supplements such as vitamin D and fish oil in the hopes of staving off major killers like cancer and heart disease.

But the evidence about the possible benefits of the supplements has been mixed.

Now, long-awaited government-funded research has produced some of the clearest evidence yet about the usefulness of taking the supplements. And the results — published in two papers — are disappointing.

“Both trials were negative,” says Dr. Lawrence Fine, chief of the clinical application and prevention branch of the National Heart, Lung, and Blood Institute, a part of the National Institutes of Health, which funded the studies.

“Overall, they showed that neither fish oil nor vitamin D actually lowered the incidence of heart disease or cancer,” Fine says.

The results were presented at the American Heart Association Scientific Sessions in Chicago and released online Saturday by the New England Journal of Medicine. One paper focused on vitamin D supplementation and the other focused on fish oil.

The trials involved nearly 26,000 healthy adults age 50 and older with no history of cancer or heart disease who took part in the VITAL research project. Twenty percent of the participants were African-American.

Some of the participants took either 1 gram of fish oil — which contains omega-3 fatty acids — plus 2,000 international units of vitamin D daily. Others consumed the same dose of vitamin D plus a placebo, while others ingested the same dose of fish oil plus a placebo. The last group took two placebos. After more than five years, researchers were unable to find any overall benefit.

While the overall results were disappointing, there appeared to be a beneficial effect when it came to one aspect of heart disease and fish oil: heart attacks.

Taking fish oil lowered the risk of heart attack by about 28 percent, which is a “statistically significant” finding, says Dr. JoAnn Manson, who is chief of the division of preventive medicine at the Brigham and Women’s Hospital in Boston. She led the research.

Those who appeared to benefit the most were people who didn’t ordinarily eat much fish in their day-to-day diet, as well as African Americans, Manson says.

African-Americans in the study experienced a 77 percent lower risk of heart attack when compared to placebo, which is a “dramatic reduction,” Manson says. Further research is needed to confirm these findings, she adds, but, “in the meantime it would be reasonable for African Americans to talk with their health care providers about whether they may be candidates for taking fish oil supplements.”

In an editorial also published in the New England Journal of Medicine, authors Dr. John F. Keaney and Dr. Clifford J. Rosen, take issue with some of the analysis in the study and write that the positive findings about heart attack and African Americans and individuals who don’t eat much fish need to be interpreted with caution.

Does Vitamin D Really Protect Against Colorectal Cancer?

There were no serious side effects, such as bleeding, high blood calcium levels or gastrointestinal symptoms found with either supplement.

Manson and her colleagues plan to further analyze their data and look for possible links between vitamin D, fish oil and cognitive function, autoimmune disease, respiratory infections and depression. Earlier research suggests the supplements may have some benefit for these conditions.

In the meantime, NIH official Lawrence Fine says, don’t throw out your fish oil and vitamin D.

“At this point, if one is thinking about supplementation, either omega-3s or vitamin D, talking to your physician or healthcare provider is the next step,” Fine says.

Fine and Manson stressed that vitamin D and the omega-3 fatty acids found in fish oil are important nutrients, but the best way to get them is as part of a well-balanced diet. That includes eating fatty fish like sardines, tuna and salmon, and vitamin-D fortified cereals, milk, and orange juice.

Another study presented at the same meeting examined whether a substance derived from a component of fish oil, known as icosapent ethyl, might reduce adverse events among people who already have cardiovascular risk factors, such as hardening of the arteries, diabetes, or high blood fats known as triglycerides.

Overall, that study found there was a 25 percent risk reduction for patients taking the extract. These patients were less likely to die from heart disease, have a heart attack or stroke, be hospitalized for chest pain or need procedures such as angioplasty, stenting or bypass surgery, researchers reported.

“We are reporting a remarkable degree of risk reduction,” says Dr. Deepak Bhatt, who headed the study and is a cardiologist at Brigham and Women’s Hospital.

The study, which was also a randomized clinical trial, tracked participants for an average of five years. The volunteers took icosapent ethyl, which is sold under the brand name Vascepa and was developed by the Amarin Corporation, which funded Bhatt’s research.

The product is available by prescription only for patients with high triglycerides. But the company is expected to apply for FDA approval within the next year to expand treatment to include all high-risk cardiovascular patients.

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Early association health plans defy fears, offer comprehensive benefits

Pamela Grove, senior director of benefits for Arden Hills, Minn.-based Land O’Lakes, said the plan primarily achieves savings because of its size—about 44,000 farmers will be eligible in Minnesota and Nebraska—not because of any skimping on coverage. The plan started as a pilot in Minnesota.

Land O’Lakes, several Nevada chambers of commerce, and the National Restaurant Association have formed association plans this year and each say they want to do what’s best for small businesses and their workers by providing an option that may be a better fit for a family than what’s available in the traditional individual and small-group markets.

“Critics have done a very good job of messaging that association health plans are going to offer skimpy coverage, but the facts to date do not corroborate that claim,” said Chris Condeluci, a health policy consultant who worked with Land O’Lakes on its plan. “These are member-based organizations, and if they offer skimpy coverage, their members are going to leave and they’re certainly not going to attract new members.”

The Labor Department loosened restrictions on association health plans by allowing them to serve more employers and self-employed people in the same industry nationwide or in different professions within the same geographic region as a single large employer. Previously, association plans had a hard time meeting ERISA’s large-employer insurance requirements. The Labor Department estimated that 
4 million people could be covered under association plans in the coming years.

Some healthcare advocates and ACA supporters railed against the rule, saying it would expand the availability of junk health plans and undermine the exchanges. Democratic attorneys general in 11 states and the District of Columbia sued in late July to block the rule, and that case is pending. Some state insurance regulators, such as those in Massachusetts and California, have issued emergency rules and guidance limiting what association plans can do within their borders, fearing that access to the plans could destabilize their markets and lead to fraud and insolvencies.

But in a state like Nebraska where choice on the ACA exchange is lacking and premiums have soared, regulators welcome the chance to bring in new competition. Medica is the only insurer offering coverage on the ACA exchange. The average monthly individual premium for the second-lowest cost silver plan is rising 9.1% to $686 before subsidies in 2019 compared with 2018, according HHS data.

Bruce Ramge, Nebraska’s insurance director, said the Land O’Lakes association plan “will offer another really good choice for individuals who either don’t receive a subsidy and cannot afford coverage on the exchange or for some reason prefer not to purchase that coverage.”

Recognizing that Land O’Lakes was “one of the good players,” Grove said the state “bent over backwards to help us get it out and approved as soon as possible.”

Laura Arp, Nebraska’s life and health administrator, said the plans look a lot like what’s offered on the ACA exchange.

Modern Healthcare reviewed the plan documents for Land O’Lakes’ eight Nebraska plans, including a platinum-level plan, one gold plan, and three silver and three bronze options. They feature a range of deductibles and appear to provide coverage for each category of essential health benefits including prescription drugs, maternity care and mental health and substance abuse treatment. Land O’Lakes leases its network from Cigna Corp. in Nebraska and PreferredOne in Minnesota.

Medica is also offering an association plan with the Nebraska Farm Bureau in 2019 with average premiums about 25% less than a comparable individual exchange plan, said Geoff Bartsch, vice president of Medica’s individual and family business. Like the Land O’Lakes plan, Medica’s farm bureau insurance will cover all the essential health benefits and will not charge more for or exclude those with pre-existing conditions, he said.

Medica is able to offer lower premiums because the group of potential farm bureau members is relatively healthier than the individual market. That said, Bartsch also explained that the plan will set premiums based on age, location and industry, and is considering varying rates based on gender in the future, which will also allow some savings. ACA exchange plans are prohibited from varying rates based on industry and gender, but the Labor Department rule allows it.

In Nevada, a fully insured association health plan offered by several chambers of commerce offers HMO premiums at up to 15% to 20% less than comparable exchange plans, despite offering robust benefits, because its partner UnitedHealthcare will attract enough volume to command lower rates, said Scott Muelrath, CEO of the Henderson Chamber of Commerce. Still, the plan will vary rates based on age, occupation, location and group size.

Aaron Frazier, director of healthcare policy at the National Restaurant Association, similarly said members will see lower premiums because of the combined purchasing power of its small businesses.

In addition to size, Land O’Lakes’ self-insured status
will also help fetch savings. Being self-
insured means it will avoid certain state premium taxes, and it won’t have to pay a “risk load” or profit margin to a health insurance carrier, Condeluci explained. The plan also will vary rates based on ZIP code and age, leading older members to pay as much as four times what younger members pay. ACA exchange plans are limited to charging older patients three times more.

Insurance experts said those explanations make sense. “AHPs can offer comprehensive coverage and still be cheaper than marketplace plans if they either serve a population that is less costly than the average of the marketplace and/or they somehow are able to pay less for services,” said Katherine Hempstead, who directs the Robert Wood Johnson Foundation’s work on health insurance coverage.

The Trump administration rule did leave the door open for some plan sponsors to skimp on coverage. And it is possible that some could claim to cover the 10 categories of essential health benefits, yet still not meet federal standards, said Sabrina Corlette, health insurance expert at Georgetown University.

Critics of association plans also worry they will lure healthy individuals away from the ACA-compliant markets, causing premiums to spike for those left behind. But Land O’Lakes and the Nebraska Insurance Department rejected those concerns. Ramge, the Nebraska insurance director, said most of the people with ACA coverage receive some type of subsidy; the association plans will attract those who don’t qualify for federal financial assistance.

And since the plan is not charging premiums based on health status, Land O’Lakes’ plan gives all farmers—healthy and sick—another option, Grove said.

“If there’s only one option out there for them right now, and it isn’t feasible, then this becomes their viable option,” she added. “And I like competition. It drives us to ensure that we continue to offer good coverage at affordable prices and offer good customer services and some tools and education for those employees, because a lot of them are not healthcare-savvy. They are looking for people they can trust, and luckily they trust Land O’Lakes.”

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Three red states vote to expand Medicaid during an election where health care was the top issue

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Elections is more about the health care sector, and less drug prices, says pro

Three red states approved Medicaid expansion in Tuesday’s midterm elections, changes that will potentially cover hundreds of thousands more low-income Americans, NBC News projected.

Voters in Utah, Nebraska and Idaho were all expected to pass ballot measures to broaden the federal and state health insurance program, according to NBC. The support for Medicaid expansion, an Affordable Care Act provision, came over the objections of many officials who had so far declined to adopt it, citing budgetary constraints.

In Utah, the change could extend coverage to 150,000 low-income people, according to The Salt Lake Tribune. Another 90,000 people could get insurance in Nebraska, according to the Lincoln Journal Star. About 62,000 could receive coverage in Idaho, according to the Associated Press.

The results in the red-leaning states underscore the warming attitudes toward Obamacare and its Medicaid expansion provision that most states have adopted. The ballot measures also passed during a midterm election in which health care jumped to the top of voters’ minds and emerged as the messaging priority for the Democratic Party as it took control of the House.

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The passage of the Medicaid propositions in red-leaning states Tuesday came even as other pro-GOP states propelled Republicans — who have repeatedly tried to repeal Obamacare — to gains in the Senate.

A plurality of voters, 41 percent, said health care was the most important issue for their vote, according to preliminary exit polling. It came in well ahead of both the economy and immigration. Democratic candidates across the country hammered Republicans not only over what they called threats to the coverage guarantees for people with pre-existing conditions enshrined in Obamacare, but also over potential efforts to cut into funding for the Medicare and Medicaid programs.

Before Tuesday’s votes, 33 states and Washington, D.C., had expanded Medicaid, according to the Kaiser Family Foundation. The program is a driver behind the lower uninsured rates seen under Obamacare, but some lawmakers have raised concerns about the funds needed for the combined federal-state program.

In Utah, the ballot measure overrules a partial expansion of Medicaid that state lawmakers passed earlier this year, according to The Salt Lake Tribune. Some officials have suggested they could try to repeal the proposition, according to the newspaper. The Medicaid provision would raise about $90 million through a slight state sales tax increase to pair with federal funding.

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Building a Culture of Transparency in Health Care

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In health care today, the conversation around transparency centers on the consumer. The consumer is empowered to ask for treatment options and costs, potential treatment risks, realistic outcomes, and much more. Health care providers must respond with as much information as possible to ensure appropriate care is delivered, quality and safety are top of mind, and patients and their care team can make thoughtful care decisions.

I believe it is impossible to have complete transparency with patients without first developing a strong culture of internal transparency — among all team members, at all levels, on all issues — throughout the health care organization itself.

When team members are open and honest with each other, without fear, it leads to mutual trust, collaboration, and sharing of best practices across disciplines. Patients are the ultimate beneficiaries.

Insight Center

Shining a Light: Safer Health Care Through Transparency, a 2015 report by the National Patient Safety Foundation’s Lucian Leape Institute, states that “if transparency were a medication, it would be a blockbuster, with billions of dollars in sales and accolades the world over.” The report defines transparency as the free, uninhibited flow of information that is open to the scrutiny of others.

Barriers to internal transparency. A culture of internal transparency does not come about overnight. There can be many barriers, some of which can be quite complex. For example, employees may be reluctant to report safety issues or errors for fear of being reprimanded by their managers or shunned by their colleagues.

The Lucian Leape Institute report states that “from the quality and safety perspective, transparency is foundational for learning from mistakes and for creating a supportive environment for patients and health care workers.”

At Virginia Mason Medical Center in Seattle, for example, every employee is considered a safety inspector regardless of job or title. All our team members are expected and encouraged to file a patient safety alert whenever he or she sees anything that poses an immediate or potential safety risk. This level of internal transparency is necessary because leaders and team members cannot correct problems unless they know they exist.

Internal transparency is hindered when lessons learned aren’t shared freely across the enterprise. While many organizations have routine team huddles, it is critical to prioritize multidisciplinary huddles and encourage clinicians to break through silos by sharing information with their colleagues in other specialties and departments.

Providers are often hesitant to disclose mistakes to their patients even though a 2006 study in the Journal of General Internal Medicine concluded that full disclosure is associated with a lower likelihood of changing physicians, higher satisfaction, and greater trust.

Leaders must create a no-blame culture. The most effective way to build a culture of transparency begins with those in leadership positions. It is the responsibility of the leadership team to develop an atmosphere in which there is balanced accountability and continuous improvement and this is everyone’s shared duty. Leaders must lead by example.

A 2013 article in The Ochsner Journal, titled “Just Culture: A Foundation for Balanced Accountability and Patient Safety,” concluded that “a fair and just culture improves patient safety by empowering employees to proactively monitor the workplace and participate in safety efforts in the work environment.”

A new paradigm. When something isn’t working in health care, it can take a long time to change, but providers can reach their own unique breakthrough moment that serves as the catalyst for long-term transformation.

At Virginia Mason, we began nearly 20 years ago to create a culture in which our team members could believe zero-defect care is possible and have the tools to make this happen. We recognized that to achieve such a transformation, a paradigm shift was needed. Our management approach at the time was not nimble enough to keep up with the changing health care environment: We needed to eliminate wasteful elements from patient care, and we wanted to empower our employees to be stewards of patient safety, regardless of their job title.

To find an innovative way forward, we looked beyond our own industry because traditional approaches in health care management had not evolved much over the previous decades. In 2002, we implemented the Virginia Mason Production System (VMPS), a management method that employs basic principles of the Toyota Production System for eliminating waste (i.e., anything that lacks value from the patient’s perspective), improving quality and safety, and controlling cost.

This change did not happen easily. There were doubters and naysayers, as well as enthusiasts who were open-minded about exploring a new path. Some team members adopted a wait-and-see attitude. A few decided to leave our organization. There was a mix of optimism and a feeling of loss as it became clear that doing things as we’d always done them was no longer good enough.

By openly sharing information in employee forums and during one-on-one conversations over several months, we worked to help our team members understand that change was necessary for the future of the organization. We developed compacts with our physicians, board members, and leaders at all levels that clarified organizational expectations and what, in turn, they could expect from the organization. Our leaders — including department directors and managers — are required to practice VMPS methods and teach them to their teams. Completing a course in VMPS basics is an important part of the onboarding process for newly hired employees.  The result is a safer environment for patients and staff.

I believe all of us in health care have a moral imperative to make health care better and more affordable. Safety is the foundation of quality.

In 2004, one of our patients, Mary McClinton, died because of an avoidable error while she was in our care. That mistake shook us to our core as an organization. It also served as an inspiration to create an environment that is safe for every patient and team member, and to be open with our patients, staff, and the community about our work to continually improve safety. To honor Mrs. McClinton’s legacy, we created an annual award that recognizes a team that improves quality and safety through innovation. Their projects are shared broadly across the Virginia Mason organization so everyone understands how patients and care givers will benefit from the award-winning initiatives. Members of Mrs. McClinton’s family attend the award ceremony that is named for her.

In the United States, we have more information than ever about how to provide appropriate, high-quality care and keep patients safe. Transparency with internal and external stakeholders is essential for quality, safety, accountability, and informed decision making. As the Lucian Leape Institute report explains, transparency between clinicians and patients, among clinicians and health care organizations, and between health care organizations and the public produces safer care, better outcomes and more trust among all the involved parties.

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I Was Denied Health Care for Months Because of the Gender Marker on One Form

[Photo: A hand signs a form from offscreen.][Photo: A hand signs a form from offscreen.]

Some people seem to think that transition is as easy as checking a box—that the world has bent towards trans rights and equity, and so there is no longer a need to protect trans people.
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If anything has been made apparent by the response to a leaked memo reportedly circulated by the U.S. Department of Health and Human Services months ago, it’s that cis people know next to nothing about trans people.

Yes, HHS’s moves to accept only what it considers biological gender as grounds to gut Title IX and other anti-discrimination ordinances will be a major step backward for transgender rights—the few that we even have. But to be truly surprised by this legislation, cis people must have slept through every moment leading up to this announcement. In this century, transgender people in most states can still be fired for who we are, almost a fifth of us have been homeless at some point in our lives, and just as many have been denied medical care just for being trans. And for trans people with disabilities, the refusal to officially codify and otherwise recognize our genders as simultaneously self-determined and legitimate can put our health and lives in even greater danger.

I live with Systemic Lupus Erythematosus. If there’s an office plague going around, I’ll get it first, worst, and longest. I’m in some form of pain every hour of every day, and I will require life-sustaining medication forever. Like many people with lupus, I see a rheumatologist for my disease care—a pricey specialist that requires a referral to acquire and quarterly blood tests. Just three month’s worth of tests costs thousands of dollars.

I spent my late teens and early 20s working a job that required me to perform a gender that was not authentic to me in order to stay employed. So I was relieved when I found a very queer nonprofit opportunity. I looked forward to having insurance, helping LGBTQ folks, and dressing in ways that conformed to my gender for the first time in my professional life.

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During my new employee onboarding meeting, I struggled to choose which gender marker was best. I asked my human resources manager, who told me to pick whichever fit most closely. I didn’t (and don’t) see how my gender is relevant to any insurance proceeding, but I selected the “M” box. Soon, I had insurance and was depositing a portion of my pre-tax income into a health spending account. The setup seemed simple enough.

Or at least it did until I showed up at an appointment for my primary care physician (PCP). I had set the physical weeks in advance; without my PCP’s approval, insurance would no longer pay for me to be seen by specialists. Now, my PCP was refusing to see me. Without access to specialists, I can’t get prescription renewals for my life-sustaining medication. And I began to run low on Azathioprine, the medication that decreases my inflammation enough to make me consistently ambulatory.

With time running out and my mobility in peril, I walked into my PCP’s lobby in a huff. I sharply explained my issue: how I wasn’t being seen despite long-standing appointments, no one would renew my medications—it was as if not even medical professionals gave a damn whether I lived or died. The intake associate took small notes on her clipboard, before ferrying my message into the windowless backrooms of the hospital. She was gone for ages; I felt triumphant for having taken a half-day off rather than attempting to dash back to work after what would no doubt be an emotional experience for me.

The intake associate returned to her desk and summoned me with flattened lips and a wave of her hand. “Your insurance has an ‘M’ on it and the rest of your paperwork doesn’t. That’s why we haven’t been taking it,” she told me in a true whisper, as though it was an embarrassing mistake made by an incompetent superior. “When you get that straightened out with the insurance company you can come for your appointments here again.” And I’m sitting there in front of her thinking, Why the fuck didn’t anyone just say that before now? Why did I have to beg for such a simple answer? Was having an “M” instead of an “F” on a form really enough of a reason to keep a sick person from obtaining necessary medication? I can’t fathom why my gender marker is relevant to their administrative processes at all.

The fact that I was denied medical care for over six months because I selected a more appropriate gender marker on my employment forms tells me that cis people would rather I languish than be myself. It’s not the first or only time I’ve gotten this message about my humanity, and the Trump administration’s proposed revisions are just an extension of that bias.

Online and in person, there are many who think that attacks on tiny minority groups are a decoy to distract from some broader, dreadful threat to come. This ignores the ways that attacks on trans and queer people rally so-called cultural conservatives to more right-wing positions. Gender and sexual minorities make excellent targets for the sort of harassment that brings bullies together, from the schoolyard to the Senate.

The laxness with which cis people have told trans people not to be afraid of these proposed changes is as concerning to me as the potential results of such rollbacks. They traffic in the same lolling misinformation as the HR manager whose hippy-dippy advisement cost me hundreds of dollars in medical bills and hours on the phone with medical and insurance providers. They seem to think that transition is as easy as checking a box—that the world has bent towards trans rights and equity, and so there is no longer a need to protect trans people.

It is not. It has not. And if cis passivity in the face of major threats to transgender people’s right to exist stays as pervasive as it is today, then the only allies trans people have are ourselves, our wits, and our resilience.

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Health groups warn Brexit drugs supply risk at code ‘red’

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