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A Fresh Look at BioMarin

06:42 EDT 7 Aug 2017 | Biotech Watcher

On Wednesday, August 2, 2017, the BioMarin reported its results for Q2-2017 and held another conference call. It also announced an update of its Phase 3 program design for BMN 270 to treat Hemophilia A. Along with a major update, we take a fresh look at the evolving BioMarin story. 

Background Materials



Basic Facts for Quarter ending March 31, 2017
(In Thousands)

Q2 2017
Q1 2017
Q4 2016
Q3 2016
Q2 2016
Net Product Sales
$       315,926
$      302,190
$      298,186
$      278,262
$   298,576
  Collaborative Agreement Rev
                 -
                 -
                 -
                 1
                 -
  Royalty & License Revenue
             1,522
             1,555
             1,905
             1,633
          1,555
Total Revenues
317,448
303,745
300,091
279,896
300,131
Operating Expenses





  Cost of Goods Sold
           56,305
           50,006
           64,147
           50,738
       51,617
  R&D Costs
         143,039
        145,003
       175,242
        160,831
     167,039
  S,G&A
         143,505
        120,019
       142,958
        118,758
     109,577
  Intangible asset amortization
        (13,411)
        (8,925)
        (7,365)
        (9,654)
    (54,414)
  Impairment of intangible asset
-
-
198,700
-
599,118
  Gain on sale of intangible asset
-
-
(369,498)
-
-
Total Operating Expenses
366,260
323,953
389,712
339,981
872,937
Net Operating income (Loss)
      (38,812)
      (20,208)
      (89,621)
      (60,085)
(572,806)
Net Income (Loss)
        (36,833)
        (16,290)
        (90,720)
      (42,797)
 (423,560)
Net (Loss) per share, basic
Net (Loss) per share, diluted
             (0.21)
(0.21)
             (0.09)
(0.09)
             (0.53)
(0.53)
(0.26)             (0.26)
         (2.61)
(2.61)
Avg Shares Outstanding, basic
Avg Shares Outstanding, diluted
         172,710
172,710
        172,710
172,710
        172,006
172,240
167,714 167,714
     162,587
162,587
Recent Price / share
$           94.23
  (5/5/17)
$           94.23
  (5/5/17)
$           91.62
  (2/27/17)
$         81.02  (10/27/16)
$        99.62
   (8/3/16)
Market Capitalization
             16.3B
             16.3B
             15.8B
             13.2B
          16.2B
Cash & Investments
     1,209,812
     1,211,683
     1,362,388
     1,397,804
     704,907




































A few years ago, we mentioned that BioMarin would increase its R&D spend to speed development of its portfolio. Years ago, CEO Joe Belanoff of Corcept (CORT) discussed the problem with “large biotechs”. The expenses cab be so high that a company can have over $1B in net sales and still not be profitable. 

BioMarin is trying to change the picture.

For Q2-2017, BioMarin had non-GAAP income of $26.6M, largely due to subtracting stock compensation of $40.0M from GAAP calculations. CEO JJ Bienaime confirmed that BioMarin will be non-GAAP profitable for 2017. This will be largely due to holding the line on overall expenses while increasing revenues. 

Sales Revenue


Q2-2017
Q1-2017
Q4-2016
Q3-2016
Q2-2016
Total Aldurazyme Sales
$62.4M
$55.4M
$53.8M
$58.9M
$56.8M
Net Aldurazyme Revenue
$19.9M
$19.4M
$34.9M
$23.8M
$18.7M
Net Naglazyme Revenue
$85.7M
$80.6M
$75.0M
$77.7M
$78.4M
Net Kuvan Revenue
$102.0M
$92.3M
$90.0M
$90.9M
$90.2M
Net Vimizim Revenue
$103.2M
$105.8M
$93.8M
$80.9M
$106.8M
Net Brineura Revenue
$0.3M
-
-
-
-
Net Firdapse Revenue
$4.8M
$4.1M
$5.8M
$5.0M
$4.1M

The sales growth should brighten for future quarters. Naglazyme should squeeze some further growth over the next couple years while Vimizim should resume a positive trajectory going forward. Over the next 18 months, we’ll see Brineura build towards significant revenues.

On the other hand, Kuvan may go generic in the USA in 2020, and in the EU in 2024. You can now see the need for BioMarin’s Pegyaliase to carve a meaningful niche in the PKU market.

Guidance

BioMarin’s guidance remains largely unchanged, with modest improvements in net loss and GAAP income for FY2017. This improvement comes from a $35M one-time payment from Sarepta Therapeutics (SRPT) related tothe license and settlement agreements resolving patent litigation. This will be recognized as revenue under royalty and other revenues in Q3-2017 and will increase the top-line by $35M.


FY-2017
Guidance
Aug 2, 2017
FY-2017
Guidance
Feb 24, 2017
FY-2016
Actuals
Total BioMarin Revenues
$1,285 to $1,300
$1,250M to $1,300M
$1,117M
  Naglazyme
Unchanged
$300M to $330M
$297M
  Kuvan
Unchanged
$380M to $410M
$348M
  Vimizim
Unchanged
$400M - $430M
$354M
Cost of Sales
(% of Total Sales Revenue)        
Unchanged
17.5% to 18.5%
18.9%
SG&A
$530M to $560M
$520M to $550M
$477M
Research and Development
$610M to $640M
$620M to $650M
$662M
GAAP Net (Loss)
$(115M) to $(155M)
$(140M) to $(180M)
$(630M)
Non-GAAP Net Income (Loss)
Unchanged
$30M to $70M
$(36M)



















Need for Home Runs

BioMarin built itself around treating rare diseases, and admirably executed this pathway to success. On the conference call, VP Robert Ajer said that BioMarin increased its revenues by 15% over the last year.

BioMarin Sales & Revenues

Q2 2017
Q1 2017
Q4 2016
Q3 2016
Q2 2016
Net Product Sales
$       315,926
$      302,190
$      298,186
$      278,262
$   298,576
Royalty & License Revenue
             1,522
             1,555
             1,905
             1,633
          1,555
Total Revenues
317,448
303,745
300,091
279,896
300,131








We see a 13.4% jump over Q3-2016, but I suppose we might be missing something small, or perhaps “it’s in the neighborhood of 15%”.

The greater issue is this: BioMarin is now so large that it requires a constant series of little drugs, or an occasional blockbuster to impact its  bottom line.

Big and Small

With its release of Q2-2017 results, tiny Corcept was rewarded for reporting an $8M increase in sales. However, a $13M sales increase for Big BioMarin is a different story.

Corcept Sales Highlights
Q2-2017
Q1-2017
Q4-2016
FY-2017
Guidance
August 2017
FY-2017
Guidance
May 2017
FY-2017
Guidance
March 2017
$35.6M
(+29%)
$27.6M
(+17%)
$23.6M
(+8.8%)
$145M-$155M
$125M-$135
$120M-$130M








BioMarin’s foray into “blockbuster orphan” indications is becoming a necessary driver for valuation, this includes: cancer; hemophilia A; and Duchenne muscular dystrophy (DMD). With the current lineup, it’s no surprise that Wall Street identifies BMN 270 (hemophilia A) with driving BMRN’s valuation.[1] At its most recent R&D Day, BioMarin management identified BMRN 270 as one of its “four pillars of growth”.

Don’t get us wrong. BioMarin is at an interesting crossroads because of its success.

On Deck

Vimizim and Kuvan should drive increased revenues for 2017 and 2018.  We expect Vimzim to have about $445M to $460M in sales for 2018, while Kuvan should continue to squeeze incremental additions.

Will this be enough? We are iffy about the sales trends for FY-2018 and early 2019.  Will there be meaningful increases in sales revenue?

The following items put this into context for BMRN.

1) Brineura sets the stage for significant revenuesin 2019. The first year of sales will be miserable as the docs get educated and the CLN2 patients are “identified”.  The analyst expectations vary, but we can synthesize a middling estimate: $325M annual run rate for worldwide revenues, attained by 2022. If the treatment effectively arrests the disease, then peak revenues may someday hurdle over $700M, but only if patient lives are significantly lengthened. If rival cell therapies for CLN2 disease are successfully developed, then the sales scenario may be severely cut.

2) Pegvaliase likelyto be approved…and should capture a significant PKU niche. We expect the FDA to indicate its acceptance (or denial) of BioMarin’s regulatory filing in late August to mid-September 2017.

Ironically its strongest competition is BioMarin’s own drug: Kuvan. As part of a settlement, Par Pharma will be green lighted to bring a generic version to the US in October 2020. BioMarin’s patents should hold in Europe until 2024.

Its first niche involves Kuvan non-responders – Pegvaliase is the only choice for these patients. About 40% of PKU patients won’t respond to Kuvan.

Its second niche involves PKU patients who seek a “more normal diet”. Pegvaliase reduces toxic Phe levels more effectively than Kuvan.

It’s a good start but this won’t be a complete walk in the park.

Pegvaliase
Kuvan
Market introduction in mid-2018
About $400M in Annual Sales
Daily Injection, More Expensive
Daily Pills / Powder / Solution, Less Expensive
Some neurocognitive trends seen with long-term extension data -  a weaker case so far than Kuvan
Documented neurocognitive benefits
Strong Phe Reduction
Significant but moderate Phe Reduction in responders
During dose titration: Generally mild to moderate hypersensitivity in 39% including anaphylaxis…but most PKU patients experience Phe reduction.
About 40% of PKU patients are non-responders













3) Vosoritide looks like a winner in 2021

As we stated in April 2016: This is treating the main cause for dwarfism and represents a very large market. Unless unknown, longer-term side effects are seen, this looks like winner for BioMarin.

BioMarin reported clinically significant Phase II data, with vosoritide spurring increased growth.

There is blockbuster potential, pending analysis of efficacy in the Phase III trial. According to BioMarin management, there are over 24,000 achondroplasia patients worldwide.  

The top-line results don’t arrive until Q4-2019 and we don’t expect it on the US market until early 2021.

To Sum Up

The near-term question involves this: Will pegvaliase be approved for marketing in 2018? 

The investors appear to be strongly focused on BMN-270, a gene therapy to treat hemophilia A. Is BioMarin grooming a blockbuster? Or will it fall short?

BMN-270 to Treat Hemophilia A

If you aren’t current with past events, you might wish to examine the following:

BMN-270 Updated Results and Conference Call(August 2, 2017)

Hemophilia A is a genetic disorder cause by missing or defective levels of Factor VIII. Factor VIII is essential for blood to clot. Normal Factor VIII activity are defined as 50% to 150%. Mild hemophilia is with Factor VIII levels between 5% and 40%. At levels above 150%, there is an increasing risk of inappropriate clotting or thrombosis.

Interim Results – ISTH[2]Conference

On July 11, 2017, BioMarin investigators presented interim results from its ongoing Phase 2a trial of BMN 270 – a gene therapy to treat severe hemophilia A, by restoring the liver’s ability to produce Factor VIII. Management issued a press release and held an investor conference call.

Summary of Results

BioMarin reported positive results for 7 patients who received the high dose of BMN 270 (6e13 vg/kg).

  - Durable 1+ year response so that all patients were consistently within normal levels of Factor VIII.
  - Dramatic improvements in quality of life measures
  - Annualized bleed rate (ABR) was greatly improved
  - Eliminated the need for supplementary Factor VIII infusions

Although the sample size is small, it’s impressive. If this holds, patients could live a normal life. BioMarin management stated that the Phase 3 program would involve the 6e13 vg/kg dose.

Week
20
28
36
44
52
N (Sample Size)
7
7
7
7
7
Median Factor VIII Level
97%
122%
99%
105%
89%
Mean Factor VIII Level
118%
123%
116%
122%
104%
Range (Low, High)
(12,254)
(15,257)
(31,273)
(20,242)
(20,218)

Negative Comments

A few commentators saw a dark cloud. They pointed to the wide variability represented in the small sample - that one high dose patient was consistently experiencing excessively high Factor VIII levels. They advocated the intermediate dose (4e13 vg/kg) being a part of the upcoming Phase 3 program. The intermediate dose patients were improved within a tight range to mild disease, but not to the normal range.

Rationale

BioMarin management believed that the high dose was safe and they saw FDA and EMA officials express strong enthusiasm. The high dose appears to ensure that patients were brought into the normal range, while the intermediate dose was brought patients into mild disease. A patient with mild disease still carries risk and must lead a consciously careful lifestyle.

Nevertheless, the management was keeping their options open. The longest treated, intermediate dose patients were only at 24 weeks post-injection.

Updated Results

4e13 vg/kg Dose
Week
4
12
20
28
32
N (Sample Size)
6
6
6
3
3
Median Factor VIII Level
4%
21%
34%
41%
51%
Mean Factor VIII Level
5%
19%
31%
39%
51%
Range (Low, High)
(2, 10)
(6,32)
(7,45)
(32,44)
(48,54)

On August 2, 2017, BioMarin presented updated results from the BMN 270 study. With an additional 6 weeks of outcome data, the intermediate dose (4e13 vg/kg) patients experienced further improvement.[3] The three patients at week 32 were at normal or almost normal levels.

This additional data compelled management to add a second Phase 3 study with patients receiving the intermediate dose.

4e13 vg/kg
Moves Severe disease to Mild & Normal
Moves Severe disease to Normal
Tighter range of Factor VIII Response
Perceived lesser risk of thrombosis
Wider range of Factor VIII Response
Higher Factor VIII Expression
Four to Six Months Post-Treatment Data
1-Year Durability Confirmed
Post-treatment Factor VIII infusions reduced to zero
Post-treatment Factor VIII infusions reduced to zero
Mean annualized bleeding rate to 1%
Mean annualized bleeding rate to zero

Versus Spark Therapeutics

On August 2, 2017, Spark Therapeutics (ONCE) announced positive results from dosing its first three hemophilia A patients with SPK-8011. The patients were moved from severe to mild disease. SPK-8011 is Spark’s gene therapy for restoring Factor VIII.  Spark claims that its treatment will produce predictable, consistent Factor VIII activity (i.e. tight ranges).

Spark’s announcement helped to dampen investor enthusiasm around BMN 270.

Nevertheless, until additional SPK-8011 data is produced, it’s premature to write-off BMN270. With commercializing a gene therapy for hemophilia A, BioMarin remains a year ahead of Spark. Furthermore, the intermediate dose for BMN 270 may offer a similar treatment profile.

Milestones

BioMarin Clinical Milestones
PEGylated Phenylalanine Ammonia Lyase (Pegvaliase, PEG-PAL)
Enzyme replacement therapy that should partly cannibalize Kuvan sales. While BioMarin management sees a $1B drug, we see a smaller impact as Kuvan goes generic in 2020. Nevertheless, it may still provide a major revenue boost to BioMarin.

Pegvaliase is much more effective than Kuvan at lowering Phe in PKU patients. It will be initially aimed at Kuvan non-responders, which makes up about 40% of PKU patients. There are some neurocognitive “trends” that favor Pegvaliase, it’s not yet as solid as the evidence for Kuvan. Over time, we expect BioMarin to provide additional documentation.
Phenylketonuria (PKU)
Phase III Discontinuation Trial (Prism 302, 250 Pts)
  Top-line Results
2H-2017
  Top-line Results
2H-2017
  Ongoing Results
2H-2017
FDA Feedback on Initial BLA Submission
Aug. 2017
Submit Application to the EMA (European Union)
Q4-2017
Kuvan (Proprietary Formulation of Tetrahydrobiopertin)
Kuvan is an enzyme co-factor that aids some PKU patients with metabolizing the toxic Phe into harmless tyrosine. In some PKU patients, Kuvan significantly reduces blood levels of Phe and also positively impacts neurocognitive functioning.  Par Pharma will be marketing a generic version in October 2020.   
SPARK Phase III Study – Dietary Tolerance – 56 Pts
Ongoing Results
Mid-2017
PKU-015 Study – Neurocognitive function, Phe Levels, Safety (230 Pts ≤ 6 years)
Finish Study
Q3-2019
RIDD-HF Study – Heart Failure Treatment, Providence VA (30 Pts)
Dec. 2018
KOGNITO Phase IV Study – Neurocognitive outcome (34 Pts aged 4 or 5 years)
Finish Study
Dec. 2022
KAMPER Study – Long-Term, Open-label Safety (625 Patients)
Finish Study
Dec. 2024
Brineura - BMN 190 (Cerliponase Alfa)
This is a recombinant form of human TPP1, the enzyme deficient in patients with CLN2 disease, a form of Batten disease.  The TPP1 enzyme breaks down the storage materials that cause CLN2 disease. To reach the brain cells and the central nervous system, the treatment is delivered directly to the cerebrospinal fluid. Early results appear promising.

Brineura has orphan status from the FDA and EMA (European Union). Furthermore, it also received Breakthrough Therapy designation and then granted a priority review from the FDA.
Batten (CLN2) Disease
This is a horrible disease - a Batten's child loses about 12% to 15% of their cortical gray matter per year. There is currently no approved treatment for CLN2 disease. We expect the FDA to confirm early approval in Q2-2017 and the EU to follow later.

Management estimates there are 1,500 rather than just 500 patients in the USA. We estimate a lower-bound of a $435M peak worldwide market. We conserved our earlier estimates to match emerging pricing pressures. Nevertheless, this figure may be easily surpassed over time with significant life extension.
  Ongoing Results
TBA
  Phase I/II Siblings of CLN2 Patients: Prevention of Progression (5 Pts)
  Top-line Results
1H-2018*
BMN 111 (Vosoritide) - CNP Analog
Achondroplasia is a genetic disorder that is the most frequent cause of dwarfism. It is caused by a mutation in a single fibroblast growth factor receptor gene 3 (FGFR3). The mutant FGFR3 is overactive and thus over regulates bone growth: it restricts the conversion of cartilage into bone.

This results in dwarfs with a full height of a few inches over 4 feet. This creates structural problems that may require remediation. This includes procedures for relieving cranial and spinal compressions. There is also a concurrent problem with high blood pressure.

There is currently no approved therapy. Young patients may derive some small benefit from a temporary course of human growth hormone. A few others are subjected to limb lengthening techniques. Neither presents a real solution.

Vosoritide is derived from a natural human peptide that is a positive regulator of bone growth. Vosoritide binds to a specific receptor, which initiates intracellular signals that inhibit the overactive FGFR3 pathway.

Management believes there are about 20,000 patients in the USA and Europe, and can serve about 5,000 patients.
Achondroplasia
  Final Results
Q1-2018
Phase II  Pediatrics Extension (30 pts between 7 and 16 yrs old)
  Three dose levels: 15 µg/kg, 30 µg/kg, up to 60 µg/kg daily
  Ongoing Results & Final Results
TBA
Q4-2022
  Phase III Pivotal Study – 1-Yr Treatment (110 pts between 5 and 14)
  Two dose levels: placebo or BMN 111 at 15 μg/kg daily
  Final Results
Q4-2019
BMN 270
Hemophilia A is a genetically inherited deficiency of a blood clotting factor called “Factor VIII”. This leads to uncontrollable bleeding after trauma or spontaneous bleeding including brain hemorrhage. There are about 13,000 patients diagnosed in the USA.

BMN 270 is an Adenovirus-Associated Virus (AAV) based gene therapy to mitigate a deficiency of clotting factor VIII.  Hemophilia A is an attractive target for gene therapy because low levels are required for a clinically meaningful benefit and the current incumbent treatment requires multiple infusions a week.
Severe Hemophilia A
BioMarin hopes to source new BMN 270 from its new facility by Spring 2018. The Phase IIb efficacy trial will launch with material from an outside supplier. BioMarin hopes to show equivalence between the two sources of BMN 270. If bioequivalence cannot be established, then the trial will increase enrollment to enable approval with just patients treated from the new facility.
  Ongoing & Top-line Final Data Collection from Single Dose
TBA
Q1-2022*
  Phase III – Efficacy - 4e13 vg/kg Dose (100 Pts)
  Launch
Q4-2017
  Phase III – Efficacy - 6e13 vg/kg Dose (100 Pts)
  Launch
Q4-2017
BMN 250
Sanfilippo is a genetic disease caused by an absence of normal enzymes needed for breaking down heparan sulfate. Heparan sulfate is normally broken down by 4 different enzymes in the lysosome, the garbage incinerator of the human cell, and so Sanfilippo belongs to a group called lysosomal storage diseases.

There are four types of Sanfilippo disease (Types A, B, C, & D). With Sanfilippo B, patients lack a normal enzyme called alpha-N-acetylglucosaminidase (NAGLU). This results in the toxic accumulation of partly degraded heparin sulfate in tissues.

Sanfilippo children suffer from progressive deterioration in cognitive and motor skill development beginning at age 2. There is a progressive and eventual loss of language skills. Some children never learn to speak. There are also associated behavior problems, severe dementia, chronic diarrhea, as well as irregular sleep schedules.

By age 10, most Sanfilippo children are unable to walk and also reach their maximal height. The typical Sanfilippo B patient progresses to a vegetative state and typically dies in the 30s and 40s.

Synageva (GEVA) is developing SBC-103. In animal models, SBC-103 crosses the blood-brain barrier and reduce substrates through an intravenous, rather than intrathecal, infusion. This would be greatly preferred over BioMarin’s method of using intrathecal injections into the spinal area.

On the other hand, BioMarin management is confident it can compete with BMRN-250…that it will have improved absorption and reduction of heparin sulfate.
Sanfilippo B (MPS IIIB)
BioMarin recently began enrolling patients in this 2-part study. In Part 1, patients will receive up to 3 escalating infusions of BMN 250 (30, 100 and 300 mg) every week until the maximum tolerated tested dose (MTTD) is established. Two of 3 patients at the lowest dose had heparan sulfate levels that moved into the normal range. In Part 2, patients will receive weekly infusions of BMN250 that will continue for 48 weeks at the MTTD established in Part 1. This will be the 300 mg dose. Longer-term data will hopefully establish clinical (neurocognitive) benefit, especially in earlier stage disease.
  Phase I/II – Safety, Proof of Concept – 33 pts ages 1-yr to 10-yrs old
  Top-line Final Results
Q1-2019*
  Program Update
2H-2017
      *Guesstimate   **Independent Investigator

Our Thoughts

On Deck
Product
Notes
A regulatory filing is scheduled for mid-2017. More top-line efficacy and neurocognitive results in 2017. Will we see positive neurocognitive results?
Recently approved for the USA, we expect slow sales for the first year with a stronger uptake afterwards. The EMA is scheduled for a Q3-2017 approval decision.

Management has (unsurprisingly) found a larger market than the original estimate of 500 patients, perhaps 1,500. As the drug helps patients to live longer, peak markets may be large. This scenario is cut short if and when rival cell therapies are successfully developed.  
If approved, CEO JJ Bienaime estimates that peak sales will exceed $1B. We take a more cautious tact for now. If it maintains current results, peak revenues should exceed $650M
BMN-270
BMN-270 is an AAV-driven gene therapy that restores an essential clotting element, factor VIII, for hemophilia A. So far, extended results suggest that unlike prior AAV-delivered gene therapies, durable treatment effects are present. If these results truly hold and repeat, then this represents $650M+ in peak sales. Depending upon further robust results, this would be upwardly revised.

BioMarin is a vertically integrated biopharma that successfully growing into a mid-sized company. BioMarin no longer behaves like a small biotech. The early stage results from a single drug no longer pushes the stock up and down.

To move the needle, BioMarin is required to: 1) pursue larger revenue opportunities (e.g. hemophilia); or 2) enlarge the drug pipeline. It’s therefore no surprise that recently, investors are following news related to BMN 270.

For the past three years, we have specially underscored items that will especially impact BioMarin. This includes "The Magnificent 5", and more recently we have referred to them as simply being “On Deck”.  If these items reach the market, it will be the last handful of drug candidates that transforms the company. They can double or triple the revenue stream.

For many years, we vociferously asserted that BioMarin would not be acquired. When pegyaliase finally enters the market, this changes things. We think BioMarin finally becomes fair game. While this is a far cry from declaring acquisition, we will cease being such an adamant naysayer.

At the time this was written, one or more BioWatch staff owned a long position in BMRN


[1]BMRN’s valuation took a hit when Spark Therapeutics (ONCE) reported good data for its competitor drug. It also took a hit when BioMarin initially announced that it was only doing the high dose, 6e13 vg/kg, for its Phase 3 program. Wall Street was disappointed that an intermediate dose wasn’t on the docket. As seen in BioMarin’s Q2-2017 announcement, this situation has changed.
[2]International Society on Thrombosis and Hemostasis
[3]To quote BioMarin’s press release: “Based on the most recent data, for the three patients who were given the 4e13 vg/kg dose in November/December 2016, at week 32, all are in or near to the normal range of Factor VIII activity levels, with both median and mean Factor VIII levels of 51%. For the cohort of three patients who were given the 4e13 vg/kg dose in February/March 2017, at week 20, their Factor VIII activity levels have all moved into the mild range and two of the three are continuing to trend upward.”

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