Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing
and precision medicine, today announced financial results for its
third quarter ended September 30, 2024 and updated its
previously issued financial guidance on business performance for
the full-year 2024.
“During the third quarter of 2024, we grew revenue by 11%,
compared to the third quarter of 2023, representing a fifth
consecutive quarter of double-digit year-over-year revenue growth
and have now delivered 13% revenue growth year-to-date as compared
to the same nine-month period in 2023. This builds on the 11%
revenue growth we reported for the full year 2023 and reflects the
strength of our diversified product offerings, improved commercial
execution, and the benefits of the enterprise-wide investments made
over the last few years to improve customer service and ease of
use,” said Paul J. Diaz, President and CEO of Myriad Genetics. “We
continue to focus on delivering profitable growth and free cash
flow and are pleased with the significant progress we have made
across the organization. These efforts, combined with prudent
management of our cost structure, contributed to Myriad Genetics
generating an improved net loss of $22.1 million and over $14
million in adjusted EBITDA in the third quarter. In October 2024,
we hosted an investor event where we provided additional detail on
our strategic initiatives, including enhancements to our existing
products, and an update on our new product pipeline. These new
products, once commercialized, have the potential to address a
number of large market opportunities where we believe we will have
highly differentiated proprietary solutions, providing us
opportunities to accelerate growth going forward. These
opportunities build on our mission and vision to reach more
patients with life-changing precision medicine. Unfortunately,
differentiated solutions often face obstacles to gain broad payor
acceptance, as we recently experienced with UNH and its updated
medical policy on multi-gene panel pharmacogenetic testing. We are
disappointed UNH is restricting access to GeneSight, an important
tool for healthcare providers, especially primary care providers,
to help patients suffering from depression and anxiety to find the
right medication treatment. We look forward to sharing additional
clinical evidence for GeneSight with UNH and finding a positive
resolution for patients.”
_______________1 The company does not forecast GAAP EPS because
it cannot predict certain elements that are included in the
reported GAAP results. Please see below under "Financial Guidance"
for a full explanation.
Financial and Operational Highlights
- Test volumes of 376,000 in the third quarter of 2024 increased
6% year-over-year.
- The following table summarizes year-over-year testing volume
changes in the company's core product categories:
|
Three months ended September 30, |
|
Nine Months Ended September 30, |
(in thousands) |
2024 |
|
2023 |
|
% Change |
|
2024 |
|
2023 |
|
% Change |
Product volumes: |
|
|
|
|
|
|
|
|
|
|
|
Hereditary cancer |
74 |
|
71 |
|
5 |
% |
|
219 |
|
207 |
|
5 |
% |
Tumor profiling |
13 |
|
13 |
|
— |
% |
|
41 |
|
45 |
|
(9 |
)% |
Prenatal |
162 |
|
156 |
|
3 |
% |
|
506 |
|
469 |
|
8 |
% |
Pharmacogenomics |
127 |
|
116 |
|
10 |
% |
|
380 |
|
343 |
|
11 |
% |
Total |
376 |
|
356 |
|
6 |
% |
|
1,146 |
|
1,064 |
|
8 |
% |
- The following table summarizes year-over-year revenue changes
in the company's core product categories:
|
Three months ended September 30, |
|
Nine Months Ended September 30, |
(in millions) |
|
2024 |
|
|
2023 |
|
% Change |
|
|
2024 |
|
|
2023 |
|
% Change |
Product revenues: |
|
|
|
|
|
|
|
|
|
|
|
Hereditary cancer |
$ |
90.5 |
|
$ |
86.5 |
|
5 |
% |
|
$ |
270.1 |
|
$ |
238.9 |
|
13 |
% |
Tumor profiling |
|
31.6 |
|
|
30.2 |
|
5 |
% |
|
|
95.1 |
|
|
103.5 |
|
(8 |
)% |
Prenatal |
|
43.5 |
|
|
39.5 |
|
10 |
% |
|
|
132.2 |
|
|
111.3 |
|
19 |
% |
Pharmacogenomics |
|
47.7 |
|
|
35.7 |
|
34 |
% |
|
|
129.6 |
|
|
102.9 |
|
26 |
% |
Total |
$ |
213.3 |
|
$ |
191.9 |
|
11 |
% |
|
$ |
627.0 |
|
$ |
556.6 |
|
13 |
% |
|
|
|
|
|
|
|
- Gross margin of 70.2% in the third quarter of 2024 increased 20
basis points year-over-year, reflecting operating leverage and
improved average revenue per test. Adjusted gross margin in the
third quarter of 2024 was 70.6%, an increase of 20 basis points
year-over-year.
- Third quarter 2024 operating expenses were $169.8 million,
decreasing 13% over the same period in the prior year due to
significant legal costs incurred in the third quarter of 2023 that
did not repeat in the third quarter of 2024. Operating expenses
accounted for 80% of total revenue in the third quarter of 2024,
down from 101% of total revenue in the third quarter of 2023.
Adjusted operating expenses were $141.0 million, increasing 3% over
the same period in the prior year and reflect ongoing investments
in technology, research and development offset by cost management
activities. Adjusted operating expenses accounted for 66% of total
revenue in the third quarter of 2024, down from 72% of total
revenue in the third quarter of 2023.
- Operating loss in the third quarter of 2024 was $20.0 million,
improving $40.1 million year-over-year; adjusted operating income
in the third quarter of 2024 was $9.5 million, improving $11.7
million year-over-year.
Business Performance and Highlights
Oncology
The Oncology business delivered revenue of $82.9 million in
the third quarter of 2024.
- Third quarter 2024 hereditary cancer testing revenue in
Oncology grew 11% year-over-year, reflecting both volume growth
year-over-year and ongoing initiatives to improve average revenue
per test.
- Third quarter 2024 tumor profiling revenue of $31.6 million
grew 5% year-over-year, as contributions from Precise Tumor and
Prolaris were partly offset by a challenged biopharma environment
and the sale of the EndoPredict business on August 1, 2024.
- In October 2024, Myriad Genetics entered a collaboration with
Flatiron Health, a leading health technology company, that allows
physicians to order Myriad Genetics’ MyRisk Hereditary Cancer Test
and view the results of the test directly in Flatiron’s cloud-based
Electronic Medical Record (EMR) platform, OncoEMR.
- In October 2024, Myriad Genetics received a third patent
relating to proprietary methods that generate ultra-sensitive
detection of tumor-specific mutations in circulating tumor DNA
(ctDNA), which is complementary to two patents granted earlier in
the year for the company’s methods of preparing cell-free DNA.
These patents support advancing commercialization of the company's
high sensitivity tumor informed molecular residual disease (MRD)
assay.
- Myriad Genetics has established a number of additional research
collaborations regarding the use of the company's Precise MRD test
for breast cancer patients, with leading cancer research
institutions, including The University of Texas MD Anderson Cancer
Center and the National Cancer Center Hospital East in Japan.
Myriad Genetics has previously announced other MRD collaborations,
including a metastatic breast cancer study with researchers at
Memorial Sloan Kettering Cancer Center and a prospective pan-cancer
study, including breast cancer, led by researchers at the National
Cancer Center Hospital East in Japan.
Women’s Health
The Women’s Health business delivered revenue of $82.7 million
in the third quarter of 2024.
- Prenatal testing revenue in the third quarter of 2024 grew 10%
year-over-year, reflecting volume growth and ongoing initiatives to
improve average revenue per test.
- Third quarter 2024 hereditary cancer testing revenue in Women's
Health declined 2% year-over-year with modest volume growth which
was offset by the fact that a favorable change in estimate for
average revenue per test in the third quarter of 2023 did not
repeat in the third quarter of 2024. Year-to-date 2024 hereditary
cancer testing revenue in Women's Health grew 12% compared to the
same nine-month period in 2023 as we believe more practitioners
have seen the benefit of incorporating MyRisk with RiskScore as
part of a comprehensive breast cancer risk assessment program.
- In October 2024, Myriad Genetics initiated a satellite media
tour to coincide with new FDA guidelines to drive increased
awareness and engagement around the connection between breast
density and cancer risk. New FDA guidelines provide that
mammography facilities are required to provide all patients
receiving a mammogram with a breast density notification.
- In October 2024, Myriad Genetics established a strategic
partnership with jscreen, a national organization providing access
to genetic testing with a focus on high-risk populations. The
partnership intends to reach hundreds of thousands of high-risk
adults across the United States through targeted outreach and
in-person genetic screenings.
Pharmacogenomics
In the pharmacogenomics business, GeneSight test revenue was
$47.7 million in the third quarter of 2024.
- Third quarter 2024 GeneSight testing revenue grew 34%
year-over-year, reflecting double-digit test volume growth
year-over-year and ongoing initiatives to improve payor coverage
and average revenue per test.
- Currently, biomarker legislation for state-regulated plans has
passed in 15 states. In many of these states, commercial and
managed Medicaid payers have modified their coverage policies to
include GeneSight. Additionally, there are a number of states where
legislation is in process. Myriad Genetics continues to see an
increasing number of payors incorporating, or planning to
incorporate, GeneSight into their coverage.
- During the third quarter of 2024, Myriad Genetics expanded
payor coverage for several products, including GeneSight. Third
quarter saw an additional 17 new contracts and expanded medical
policies and coverage, enhancing access to our products, including
GeneSight.
- On November 1, 2024, UNH updated its medical policy for
pharmacogenetic testing to no longer provide coverage for certain
multi-gene panel pharmacogenetic tests, including our GeneSight
test, under its commercial and individual exchange benefit plans,
effective January 1, 2025. After initial review of the updated
policy, the company strongly disagrees with UNH’s decision and its
rationale that there is insufficient evidence of efficacy to
support coverage of GeneSight. Myriad Genetics is actively engaging
with UnitedHealthcare to discuss additional evidence for Myriad
Genetics’ proprietary and clinically differentiated mental health
medication test, and is seeking to ensure that enrollees continue
to have access to the test. We do not believe that the updated
policy affects coverage of GeneSight by UNH under Medicare
Advantage and managed Medicaid plans or coverage by other
payors.
Cash Flow and LiquidityFor the third quarter of
2024, restricted and unrestricted cash increased by $8.6 million.
As of the end of the third quarter of 2024, the company had cash
and cash equivalents, excluding restricted cash, of $99.9 million
and the ability to access an incremental $48.8 million of
availability under its asset-based credit facility (the "ABL
Facility"). The company had combined liquidity from its
unrestricted cash and cash equivalents of $148.7 million.
Financial GuidanceMyriad
Genetics does not provide forward-looking guidance on a GAAP basis
for the measures on which it provides forward-looking non-GAAP
guidance as the company is unable to provide a quantitative
reconciliation of forward-looking non-GAAP measures to the most
directly comparable forward-looking GAAP measure, without
unreasonable effort, because of the inherent difficulty in
accurately forecasting the occurrence and financial impact of the
various adjusting items necessary for such reconciliations that
have not yet occurred, are dependent on various factors, are out of
the company's control, or cannot be reasonably predicted. Such
adjustments include, but are not limited to, real estate
optimization and transformation initiatives, certain litigation
charges and loss contingencies, costs related to
acquisitions/divestitures and the related amortization, impairment
and related charges, and other adjustments. For example,
stock-based compensation may fluctuate based on the timing of
employee stock transactions and unpredictable fluctuations in the
company's stock price. Any associated estimate of these items and
its impact on GAAP performance could vary materially.
Below is a table summarizing Myriad Genetics' fiscal year 2024
financial guidance*:
(in
millions, except per share amounts) |
INITIAL (as ofFebruary 27) |
PRIOR(as of August 6) |
CURRENT FY 2024 |
|
Expected Year-Over-Year Change |
|
|
|
|
|
|
|
Revenue |
$820 - $840 |
$835 - $845 |
$837 - $843 |
|
11% - 12% |
Gross margin % |
69.5% - 70.5% |
70.0% - 70.5% |
69.8% - 70.3% |
|
100 - 150 bps |
Adjusted OPEX |
$572 - $582 |
$575 - $585 |
$565 - $570 |
|
4% - 5% |
Adjusted EBITDA** |
$20 - $30 |
$25 - $35 |
$34 - $39 |
|
$45 - $50 |
Adjusted EPS*** |
$0.00 - $0.05 |
$0.08 - $0.12 |
$0.12 - $0.14 |
|
$0.39 - $0.41 |
|
|
|
|
|
|
|
* |
Assumes currency
rates as of November 7, 2024. |
** |
Adjusted EBITDA is
defined as Net Income (loss) plus income tax expense (benefit),
total other income (expense), non-cash operating expenses, such as
amortization of intangible assets, depreciation, impairment of
long-lived assets, and share-based compensation expense, and
one-time expenses such as expenses from real estate optimization
initiatives, transformation initiatives, legal settlements, and
divestitures and acquisitions. |
*** |
Full-year 2024
adjusted EPS is based on a 92 million share count. |
These projections are forward-looking statements and are subject
to the risks summarized in the safe harbor statement at the end of
this press release.
Conference Call and WebcastA conference call
will be held today, Thursday, November 7, 2024, at 4:30 p.m. ET to
discuss Myriad Genetics’ financial results and business
developments for the third quarter 2024. A live webcast of the
conference call can be accessed on Myriad Genetics' Investor
Relations website at investor.myriad.com. To participate in the
live conference call via telephone, please register at
https://edge.media-server.com/mmc/p/cnfp9pdm/. Upon registering, a
dial-in number and unique PIN will be provided to join the
conference call. Following the conference call, an archived webcast
of the call will be available at investor.myriad.com.
About Myriad GeneticsMyriad Genetics is a
leading genetic testing and precision medicine company dedicated to
advancing health and well-being for all. Myriad Genetics provides
insights that help people take control of their health and enable
healthcare providers to better detect, treat, and prevent disease.
Myriad Genetics develops and offers genetic tests that help assess
the risk of developing disease or disease progression and guide
treatment decisions across medical specialties where critical
genetic insights can significantly improve patient care and lower
healthcare costs. For more information, visit www.myriad.com.
Myriad, the Myriad logo, BRACAnalysis, BRACAnalysis CDx,
Colaris, MyRisk, Myriad myRisk, MyRisk Hereditary Cancer, myChoice,
Tumor BRACAnalysis CDx, MyChoice CDx, Prequel, Prequel with
Amplify, Amplify, Foresight, Foresight Universal Plus, Precise
Tumor, Precise Oncology Solutions, Precise Liquid, Precise MRD,
FirstGene, SneakPeek, SneakPeek Early Gender DNA Test, SneakPeek
Snap, Urosuite, Mygenehistory, Health.Illuminated., RiskScore,
Prolaris, and GeneSight are registered trademarks or trademarks of
Myriad Genetics, Inc. All third-party marks—® and ™—are the
property of their respective owners. © 2024 Myriad Genetics, Inc.
All rights reserved.
Revenue by Product (Unaudited)
|
Three months ended September 30, |
(in millions) |
|
2024 |
|
|
2023 |
|
|
|
WH |
ONC |
PGx |
Total |
|
WH |
ONC |
PGx |
Total |
|
% Change |
Hereditary Cancer |
$ |
39.2 |
$ |
51.3 |
$ |
— |
$ |
90.5 |
|
$ |
40.2 |
$ |
46.3 |
$ |
— |
$ |
86.5 |
|
5 |
% |
Tumor Profiling |
|
— |
|
31.6 |
|
— |
|
31.6 |
|
|
— |
|
30.2 |
|
— |
|
30.2 |
|
5 |
% |
Prenatal |
|
43.5 |
|
— |
|
— |
|
43.5 |
|
|
39.5 |
|
— |
|
— |
|
39.5 |
|
10 |
% |
Pharmacogenomics |
|
— |
|
— |
|
47.7 |
|
47.7 |
|
|
— |
|
— |
|
35.7 |
|
35.7 |
|
34 |
% |
Total Revenue |
$ |
82.7 |
$ |
82.9 |
$ |
47.7 |
$ |
213.3 |
|
$ |
79.7 |
$ |
76.5 |
$ |
35.7 |
$ |
191.9 |
|
11 |
% |
|
Nine months ended September 30, |
(in millions) |
|
2024 |
|
|
2023 |
|
|
|
WH |
ONC |
PGx |
Total |
|
WH |
ONC |
PGx |
Total |
|
% Change |
Hereditary Cancer |
$ |
120.7 |
$ |
149.4 |
$ |
— |
$ |
270.1 |
|
$ |
107.6 |
$ |
131.3 |
$ |
— |
$ |
238.9 |
|
13 |
% |
Tumor Profiling |
|
— |
|
95.1 |
|
— |
|
95.1 |
|
|
— |
|
103.5 |
|
— |
|
103.5 |
|
(8 |
)% |
Prenatal |
|
132.2 |
|
— |
|
— |
|
132.2 |
|
|
111.3 |
|
— |
|
— |
|
111.3 |
|
19 |
% |
Pharmacogenomics |
|
— |
|
— |
|
129.6 |
|
129.6 |
|
|
— |
|
— |
|
102.9 |
|
102.9 |
|
26 |
% |
Total Revenue |
$ |
252.9 |
$ |
244.5 |
$ |
129.6 |
$ |
627.0 |
|
$ |
218.9 |
$ |
234.8 |
$ |
102.9 |
$ |
556.6 |
|
13 |
% |
Business Units:WH = Women’s HealthONC =
OncologyPGx = Pharmacogenomics
Product Categories:Hereditary Cancer – MyRisk,
BRACAnalysis, BRACAnalysis CDxTumor Profiling – myChoice CDx,
Prolaris, Precise Tumor, EndoPredictPrenatal – Foresight, Prequel,
SneakPeekPharmacogenomics – GeneSight
MYRIAD GENETICS, INC.AND
SUBSIDIARIESCondensed Consolidated Statements of
Operations (unaudited)(in millions, except per share amounts) |
|
|
Three months endedSeptember
30, |
|
Nine months endedSeptember
30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Testing revenue |
$ |
213.3 |
|
|
$ |
191.9 |
|
|
$ |
627.0 |
|
|
$ |
556.6 |
|
Costs and expenses: |
|
|
|
|
|
|
|
Cost of testing revenue |
|
63.5 |
|
|
|
57.6 |
|
|
|
192.5 |
|
|
|
174.6 |
|
Research and development expense |
|
28.5 |
|
|
|
24.0 |
|
|
|
81.2 |
|
|
|
67.7 |
|
Selling, general, and administrative expense |
|
139.1 |
|
|
|
136.1 |
|
|
|
424.0 |
|
|
|
428.5 |
|
Legal settlements |
|
— |
|
|
|
34.3 |
|
|
|
— |
|
|
|
111.8 |
|
Goodwill and long-lived asset impairment charges |
|
2.2 |
|
|
|
— |
|
|
|
13.8 |
|
|
|
— |
|
Total costs and expenses |
|
233.3 |
|
|
|
252.0 |
|
|
|
711.5 |
|
|
|
782.6 |
|
Operating loss |
|
(20.0 |
) |
|
|
(60.1 |
) |
|
|
(84.5 |
) |
|
|
(226.0 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Interest income |
|
0.4 |
|
|
|
0.6 |
|
|
|
1.4 |
|
|
|
1.8 |
|
Interest expense |
|
(0.8 |
) |
|
|
(1.0 |
) |
|
|
(2.1 |
) |
|
|
(2.0 |
) |
Other |
|
(0.8 |
) |
|
|
(0.7 |
) |
|
|
0.8 |
|
|
|
(3.7 |
) |
Total other income (expense), net |
|
(1.2 |
) |
|
|
(1.1 |
) |
|
|
0.1 |
|
|
|
(3.9 |
) |
Loss before income tax |
|
(21.2 |
) |
|
|
(61.2 |
) |
|
|
(84.4 |
) |
|
|
(229.9 |
) |
Income tax expense |
|
0.9 |
|
|
|
0.1 |
|
|
|
0.4 |
|
|
|
2.2 |
|
Net loss |
$ |
(22.1 |
) |
|
$ |
(61.3 |
) |
|
$ |
(84.8 |
) |
|
$ |
(232.1 |
) |
Net loss per share: |
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.24 |
) |
|
$ |
(0.75 |
) |
|
$ |
(0.94 |
) |
|
$ |
(2.84 |
) |
Weighted average shares
outstanding: |
|
|
|
|
|
|
|
Basic and diluted |
|
90.9 |
|
|
|
81.9 |
|
|
|
90.5 |
|
|
|
81.6 |
|
MYRIAD GENETICS, INC.AND
SUBSIDIARIESCondensed Consolidated Balance Sheets
(unaudited)(in millions) |
|
|
September 30,2024 |
|
December 31,2023 |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
99.9 |
|
|
$ |
132.1 |
|
Marketable investment securities |
|
— |
|
|
|
8.8 |
|
Trade accounts receivable |
|
125.7 |
|
|
|
114.3 |
|
Inventory |
|
26.2 |
|
|
|
22.0 |
|
Prepaid taxes |
|
17.0 |
|
|
|
17.0 |
|
Prepaid expenses and other current assets |
|
24.4 |
|
|
|
19.4 |
|
Total current assets |
|
293.2 |
|
|
|
313.6 |
|
Operating lease right-of-use
assets |
|
57.4 |
|
|
|
61.6 |
|
Property, plant and equipment,
net |
|
115.4 |
|
|
|
119.0 |
|
Intangibles, net |
|
312.5 |
|
|
|
349.5 |
|
Goodwill |
|
286.3 |
|
|
|
287.4 |
|
Other assets |
|
16.5 |
|
|
|
15.4 |
|
Total assets |
$ |
1,081.3 |
|
|
$ |
1,146.5 |
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
|
29.6 |
|
|
|
25.8 |
|
Accrued liabilities |
|
111.2 |
|
|
|
113.9 |
|
Current maturities of operating lease liabilities |
|
13.5 |
|
|
|
16.2 |
|
Total current liabilities |
|
154.3 |
|
|
|
155.9 |
|
Unrecognized tax benefits |
|
31.4 |
|
|
|
30.2 |
|
Long-term debt |
|
39.0 |
|
|
|
38.5 |
|
Noncurrent operating lease
liabilities |
|
90.6 |
|
|
|
97.4 |
|
Other long-term
liabilities |
|
34.3 |
|
|
|
41.3 |
|
Total liabilities |
|
349.6 |
|
|
|
363.3 |
|
Commitments and
contingencies |
|
|
|
Stockholders’ equity: |
|
|
|
Common stock, 91.0 and 89.9
shares outstanding at September 30, 2024 and December 31,
2023, respectively |
|
0.9 |
|
|
|
0.9 |
|
Additional paid-in capital |
|
1,445.2 |
|
|
|
1,415.5 |
|
Accumulated other comprehensive loss |
|
(0.1 |
) |
|
|
(3.7 |
) |
Accumulated deficit |
|
(714.3 |
) |
|
|
(629.5 |
) |
Total stockholders' equity |
|
731.7 |
|
|
|
783.2 |
|
Total liabilities and stockholders’ equity |
$ |
1,081.3 |
|
|
$ |
1,146.5 |
|
MYRIAD GENETICS, INC.AND
SUBSIDIARIESCondensed Consolidated Statements of Cash
Flows (unaudited)(in millions) |
|
|
Three months endedSeptember
30, |
|
Nine months endedSeptember
30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Net cash provided by (used in)
operating activities |
$ |
0.7 |
|
|
$ |
(22.1 |
) |
|
$ |
(15.3 |
) |
|
$ |
(56.2 |
) |
Net cash provided by (used in)
investing activities |
|
7.5 |
|
|
|
(2.5 |
) |
|
|
(6.0 |
) |
|
|
43.9 |
|
Net cash provided by (used in)
financing activities |
|
(3.1 |
) |
|
|
(2.5 |
) |
|
|
(9.5 |
) |
|
|
31.0 |
|
Effect of foreign exchange
rates on cash, cash equivalents, and restricted cash |
|
1.2 |
|
|
|
(0.6 |
) |
|
|
(0.3 |
) |
|
|
(0.1 |
) |
Change in cash and cash
equivalents classified as held for sale(1) |
|
2.3 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net increase (decrease) in
cash, cash equivalents, and restricted cash |
|
8.6 |
|
|
|
(27.7 |
) |
|
|
(31.1 |
) |
|
|
18.6 |
|
Cash, cash equivalents, and
restricted cash at beginning of the period |
|
101.2 |
|
|
|
112.7 |
|
|
|
140.9 |
|
|
|
66.4 |
|
Cash, cash equivalents, and
restricted cash at end of the period |
$ |
109.8 |
|
|
$ |
85.0 |
|
|
$ |
109.8 |
|
|
$ |
85.0 |
|
(1) The change is
associated with the divestiture of the EndoPredict business that
was completed during the three months ended September 30, 2024,
that was classified as held for sale at June 30, 2024. |
Safe Harbor StatementThis press release
contains “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995, including the
company's updated fiscal year 2024 financial guidance, statements
relating to the company’s product pipeline and how these new
products, once commercialized, have the potential to address a
number of large market opportunities where the company believes it
will have highly differentiated proprietary solutions, providing
the company with opportunities to accelerate growth going forward,
and statements about UnitedHealthcare's recent decision to no
longer provide coverage for certain multi-gene panel
pharmacogenetic tests, such as GeneSight, under its commercial and
individual exchange benefit plans, effective January 1, 2025, and
the company's continued engagement with UnitedHealthcare to find a
positive resolution for patients, including continued access to
GeneSight. These “forward-looking statements” are management’s
present expectations of future events as of the date hereof and are
subject to a number of known and unknown risks and uncertainties
that could cause actual results, conditions, and events to differ
materially and adversely from those anticipated.
These risks include, but are not limited to: the risk that sales
and profit margins of the company’s existing tests may decline; the
risk that the company may not be able to operate its business on a
profitable basis; risks related to the company’s ability to achieve
certain revenue growth targets and generate sufficient revenue from
its existing product portfolio or in launching and commercializing
new tests to be profitable; risks related to changes in
governmental or private insurers’ coverage and reimbursement levels
for the company’s tests or the company’s ability to obtain
reimbursement for its new tests at comparable levels to its
existing tests, including risks to the company's business and
financial results associated with UnitedHealthcare's recent update
to its medical policy for pharmacogenetic testing to no longer
provide coverage for certain multi-gene panel pharmacogenetic
tests, such as GeneSight, under its commercial and individual
exchange benefit plans, effective January 1, 2025, and the
company's pursuit of a resolution with respect thereto that may
benefit the company and patients that could benefit from GeneSight;
risks related to increased competition and the development of new
competing tests; the risk that the company may be unable to develop
or achieve commercial success for additional tests in a timely
manner, or at all; the risk that the company may not successfully
develop new markets or channels for its tests; the risk that
licenses to the technology underlying the company’s tests and any
future tests are terminated or cannot be maintained on satisfactory
terms; risks related to delays or other problems with operating the
company’s laboratory testing facilities and the transition of such
facilities to the company's new laboratory testing facilities;
risks related to public concern over genetic testing in general or
the company’s tests in particular; risks related to regulatory
requirements or enforcement in the United States and foreign
countries and changes in the structure of the healthcare system or
healthcare payment systems; risks related to the company’s ability
to obtain new corporate collaborations or licenses and acquire or
develop new technologies or businesses on satisfactory terms, if at
all; risks related to the company’s ability to successfully
integrate and derive benefits from any technologies or businesses
that it licenses, acquires or develops; the risk that the company
is not able to secure additional financing to fund its business, if
needed, in a timely manner or on favorable terms, if it all; risks
related to the company’s projections or estimates about the
potential market opportunity for the company’s current and future
products; the risk that the company or its licensors may be unable
to protect or that third parties will infringe the proprietary
technologies underlying the company’s tests; the risk of
patent-infringement claims or challenges to the validity of the
company’s patents; risks related to changes in intellectual
property laws covering the company’s tests, or patents or
enforcement, in the United States and foreign countries; risks
related to security breaches, loss of data and other disruptions,
including from cyberattacks; risks of new, changing and competitive
technologies in the United States and internationally and that the
company may not be able to keep pace with the rapid technology
changes in its industry, or properly leverage new technologies to
achieve or sustain competitive advantages in its products; the risk
that the company may be unable to comply with financial or
operating covenants under the company’s credit or lending
agreements; the risk that the company may not be able to maintain
effective disclosure controls and procedures and internal control
over financial reporting; risks related to current and future
investigations, claims or lawsuits, including derivative claims,
product or professional liability claims, and risks related to the
amount of the company's insurance coverage limits and scope of
insurance coverage with respect thereto; and other factors
discussed under the heading “Risk Factors” contained in Item 1A of
the company’s Annual Report on Form 10-K filed with the U.S.
Securities and Exchange Commission (SEC) on February 28, 2024 as
updated in the company's Quarterly Report on Form 10-Q filed with
the SEC on May 8, 2024, as well as any further updates to those
risk factors filed from time to time in the company’s Quarterly
Reports on Form 10-Q or Current Reports on Form 8-K. Myriad
Genetics is not under any obligation, and it expressly disclaims
any obligation, to update or alter any forward-looking statements,
whether as a result of new information, future events or otherwise
except as required by law.
Statement regarding use of non-GAAP
financial measuresIn this press release, the company’s
financial results and financial guidance are provided in accordance
with accounting principles generally accepted in the United States
(GAAP) and using certain non-GAAP financial measures. Management
believes that presentation of operating results using non-GAAP
financial measures provides useful supplemental information to
investors and facilitates the analysis of the company’s core
operating results and comparison of operating results across
reporting periods. Management also uses non-GAAP financial measures
to establish budgets and to manage the company’s business. A
reconciliation of the GAAP financial results to non-GAAP financial
results is included in the schedules below and a description of the
adjustments made to the GAAP financial measures is included at the
end of the schedules.
The company encourages investors to carefully consider its
results under GAAP, as well as its supplemental non-GAAP
information and the reconciliation between these presentations, to
more fully understand its business. Non-GAAP financial results are
reported in addition to, and not as a substitute for, or superior
to, financial measures calculated in accordance with
GAAP.
The company does not forecast GAAP operating expenses, net
income (loss) or earnings per share because it cannot predict
certain elements that are included in reported GAAP
results. Please see above under “Financial Guidance”
for a full explanation.
Reconciliation of GAAP to Non-GAAP Financial
Measuresfor the Three and Nine Months Ended
September 30, 2024 and 2023(unaudited data in millions,
except per share amounts)
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Adjusted Gross
Margin |
|
|
|
|
|
|
|
Gross Profit (1) |
$ |
149.8 |
|
|
$ |
134.3 |
|
|
$ |
434.5 |
|
|
$ |
382.0 |
|
Acquisition - amortization of intangible assets |
|
0.3 |
|
|
|
0.4 |
|
|
|
0.9 |
|
|
|
1.1 |
|
Equity compensation |
|
0.3 |
|
|
|
0.4 |
|
|
|
1.2 |
|
|
|
1.0 |
|
Transformation initiatives |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
0.2 |
|
Other adjustments |
|
0.1 |
|
|
|
— |
|
|
|
0.5 |
|
|
|
— |
|
Adjusted Gross Profit |
$ |
150.5 |
|
|
$ |
135.1 |
|
|
$ |
437.1 |
|
|
$ |
384.3 |
|
Adjusted Gross Margin |
|
70.6 |
% |
|
|
70.4 |
% |
|
|
69.7 |
% |
|
|
69.0 |
% |
(1) Consists of
total revenues less cost of testing revenue from the Condensed
Consolidated Statements of Operations. |
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Adjusted Operating
Expenses |
|
|
|
|
|
|
|
Operating Expenses (1) |
$ |
169.8 |
|
|
$ |
194.4 |
|
|
$ |
519.0 |
|
|
$ |
608.0 |
|
Acquisition - amortization of intangible assets |
|
(10.0 |
) |
|
|
(10.3 |
) |
|
|
(30.6 |
) |
|
|
(31.0 |
) |
Goodwill and long-lived asset impairment charges |
|
(2.2 |
) |
|
|
— |
|
|
|
(13.8 |
) |
|
|
— |
|
Equity compensation |
|
(12.0 |
) |
|
|
(11.3 |
) |
|
|
(37.6 |
) |
|
|
(29.2 |
) |
Real estate optimization |
|
(2.0 |
) |
|
|
(2.7 |
) |
|
|
(5.5 |
) |
|
|
(13.7 |
) |
Transformation initiatives |
|
(2.6 |
) |
|
|
(0.1 |
) |
|
|
(6.6 |
) |
|
|
(6.9 |
) |
Legal charges, net of insurance reimbursement |
|
— |
|
|
|
(35.1 |
) |
|
|
(0.5 |
) |
|
|
(113.3 |
) |
Other adjustments |
|
— |
|
|
|
2.4 |
|
|
|
(3.5 |
) |
|
|
1.6 |
|
Adjusted Operating
Expenses |
$ |
141.0 |
|
|
$ |
137.3 |
|
|
$ |
420.9 |
|
|
$ |
415.5 |
|
(1) Consists of
research and development expense and selling, general and
administrative expense, goodwill and lived-asset impairment
charges, and legal settlements from the Condensed Consolidated
Statements of Operations. |
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Adjusted Operating
Income (Loss) |
|
|
|
|
|
|
|
Operating Loss |
$ |
(20.0 |
) |
|
$ |
(60.1 |
) |
|
$ |
(84.5 |
) |
|
$ |
(226.0 |
) |
Acquisition - amortization of intangible assets |
|
10.3 |
|
|
|
10.7 |
|
|
|
31.5 |
|
|
|
32.0 |
|
Goodwill and long-lived asset impairment charges |
|
2.2 |
|
|
|
— |
|
|
|
13.8 |
|
|
|
— |
|
Equity compensation |
|
12.3 |
|
|
|
11.7 |
|
|
|
38.9 |
|
|
|
30.3 |
|
Real estate optimization |
|
2.0 |
|
|
|
2.7 |
|
|
|
5.5 |
|
|
|
13.7 |
|
Transformation initiatives |
|
2.6 |
|
|
|
0.1 |
|
|
|
6.6 |
|
|
|
7.1 |
|
Legal charges, net of insurance reimbursement |
|
— |
|
|
|
35.1 |
|
|
|
0.5 |
|
|
|
113.3 |
|
Other adjustments |
|
0.1 |
|
|
|
(2.4 |
) |
|
|
3.9 |
|
|
|
(1.6 |
) |
Adjusted Operating Income
(Loss) |
$ |
9.5 |
|
|
$ |
(2.2 |
) |
|
$ |
16.2 |
|
|
$ |
(31.2 |
) |
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Adjusted Net Income
(Loss) (1) |
|
|
|
|
|
|
|
Net Loss |
$ |
(22.1 |
) |
|
$ |
(61.3 |
) |
|
$ |
(84.8 |
) |
|
$ |
(232.1 |
) |
Acquisition - amortization of intangible assets |
|
10.3 |
|
|
|
10.7 |
|
|
|
31.5 |
|
|
|
32.0 |
|
Goodwill and long-lived asset impairment charges |
|
2.2 |
|
|
|
— |
|
|
|
13.8 |
|
|
|
— |
|
Equity compensation |
|
12.3 |
|
|
|
11.7 |
|
|
|
38.9 |
|
|
|
30.3 |
|
Real estate optimization |
|
2.0 |
|
|
|
2.7 |
|
|
|
5.5 |
|
|
|
13.7 |
|
Transformation initiatives |
|
2.6 |
|
|
|
0.1 |
|
|
|
6.6 |
|
|
|
7.1 |
|
Legal charges, net of insurance reimbursement |
|
— |
|
|
|
35.1 |
|
|
|
0.5 |
|
|
|
113.3 |
|
Other adjustments |
|
0.1 |
|
|
|
(1.7 |
) |
|
|
2.5 |
|
|
|
— |
|
Tax adjustments |
|
(2.1 |
) |
|
|
0.4 |
|
|
|
(5.2 |
) |
|
|
9.6 |
|
Adjusted Net Income
(Loss) |
$ |
5.3 |
|
|
$ |
(2.3 |
) |
|
$ |
9.3 |
|
|
$ |
(26.1 |
) |
Weighted average shares
outstanding: |
|
|
|
|
|
|
|
Basic |
|
90.9 |
|
|
|
81.9 |
|
|
|
90.5 |
|
|
|
81.6 |
|
Diluted |
|
92.6 |
|
|
|
81.9 |
|
|
|
91.9 |
|
|
|
81.6 |
|
Adjusted Earnings (Loss) Per
Share |
|
|
|
|
|
|
|
Basic |
$ |
0.06 |
|
|
$ |
(0.03 |
) |
|
$ |
0.10 |
|
|
$ |
(0.32 |
) |
Diluted |
$ |
0.06 |
|
|
$ |
(0.03 |
) |
|
$ |
0.10 |
|
|
$ |
(0.32 |
) |
(1) To determine
Adjusted Earnings (Loss) Per Share, or adjusted EPS. |
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Adjusted
EBITDA |
|
|
|
|
|
|
|
Net Loss |
$ |
(22.1 |
) |
|
$ |
(61.3 |
) |
|
$ |
(84.8 |
) |
|
$ |
(232.1 |
) |
Acquisition - amortization of intangible assets |
|
10.3 |
|
|
|
10.7 |
|
|
|
31.5 |
|
|
|
32.0 |
|
Depreciation expense |
|
4.4 |
|
|
|
3.5 |
|
|
|
13.2 |
|
|
|
9.1 |
|
Goodwill and long-lived asset impairment charges |
|
2.2 |
|
|
|
— |
|
|
|
13.8 |
|
|
|
— |
|
Equity compensation |
|
12.3 |
|
|
|
11.7 |
|
|
|
38.9 |
|
|
|
30.3 |
|
Real estate optimization(1) |
|
2.0 |
|
|
|
2.7 |
|
|
|
5.5 |
|
|
|
13.7 |
|
Transformation initiatives |
|
2.6 |
|
|
|
0.1 |
|
|
|
6.6 |
|
|
|
7.1 |
|
Legal charges, net of insurance reimbursement |
|
— |
|
|
|
35.1 |
|
|
|
0.5 |
|
|
|
113.3 |
|
Interest expense, net of interest income(2) |
|
0.4 |
|
|
|
0.4 |
|
|
|
0.7 |
|
|
|
0.2 |
|
Other adjustments |
|
1.1 |
|
|
|
(1.6 |
) |
|
|
3.6 |
|
|
|
2.9 |
|
Income tax expense(3) |
|
0.9 |
|
|
|
0.1 |
|
|
|
0.4 |
|
|
|
2.2 |
|
Adjusted EBITDA |
$ |
14.1 |
|
|
$ |
1.4 |
|
|
$ |
29.9 |
|
|
$ |
(21.3 |
) |
(1) Real estate
optimization includes depreciation expense of $0.4 million and
$1.3 million for the three and nine months ended September 30,
2024, respectively, and $5.8 million of depreciation expense
for the nine months ended September 30, 2023. No depreciation
expense was included for the three months ended September 30,
2023. |
(2) Derived from
interest expense and interest income from the Condensed
Consolidated Statements of Operations. |
(3) Derived from
income tax (benefit) from the Condensed Consolidated Statement of
Operations. |
Adjusted Free Cash Flow
Reconciliationfor the Three and Nine Months Ended
September 30, 2024 and 2023(unaudited data in
millions)
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Adjusted free cash
flow |
|
|
|
|
|
|
|
Cash flow from operations |
$ |
0.7 |
|
|
$ |
(26.6 |
) |
|
$ |
(15.3 |
) |
|
$ |
(56.2 |
) |
Real estate optimization |
|
2.5 |
|
|
|
2.7 |
|
|
|
11.7 |
|
|
|
8.0 |
|
Transformation initiatives |
|
2.6 |
|
|
|
0.1 |
|
|
|
6.6 |
|
|
|
7.1 |
|
Legal charges, net of insurance reimbursement |
|
— |
|
|
|
21.1 |
|
|
|
0.6 |
|
|
|
23.3 |
|
Contingent consideration payment |
|
— |
|
|
|
— |
|
|
|
5.8 |
|
|
|
— |
|
Other adjustments |
|
— |
|
|
|
— |
|
|
|
3.5 |
|
|
|
0.4 |
|
Adjusted operating cash
flow |
$ |
5.8 |
|
|
$ |
(2.7 |
) |
|
$ |
12.9 |
|
|
$ |
(17.4 |
) |
Capital expenditures |
|
(3.5 |
) |
|
|
(10.9 |
) |
|
|
(15.4 |
) |
|
|
(53.2 |
) |
Capitalization of internal-use software costs |
|
(2.8 |
) |
|
|
(2.1 |
) |
|
|
(8.4 |
) |
|
|
(6.6 |
) |
Adjusted free cash flow |
$ |
(0.5 |
) |
|
$ |
(15.7 |
) |
|
$ |
(10.9 |
) |
|
$ |
(77.2 |
) |
Following is a description of the adjustments made to GAAP
financial measures:
- Acquisition – amortization of intangible assets – represents
recurring amortization charges resulting from the acquisition of
intangible assets.
- Goodwill and long-lived asset impairment charges – for the
three and nine months ended September 30, 2024, primarily the
impairment of assets held for sale related to the sale of the
EndoPredict business to Eurobio Scientific.
- Equity compensation – non-cash equity-based compensation
provided to Myriad Genetics employees and directors.
- Real estate optimization – costs related to real estate
initiatives. Prior to the fourth quarter 2023 reporting period,
these costs were included in the transformation initiatives
category. With respect to the adjusted free cash flow
reconciliation, the cash flow effect of real estate optimizations
excludes non-cash items such as accelerated depreciation and the
cash impact of items previously expensed. These costs include the
following:
- For the three months ended September 30, 2024, additional rent
as a result of the build-out of our new laboratories in Salt Lake
City, Utah, and South Francisco, California, while maintaining our
current laboratories in those locations and testing and set-up
costs for equipment in our new facilities.
- For the three months ended September 30, 2023, rent expense on
abandoned facilities and additional rent as a result of the
build-out of our new laboratories in Salt Lake City, Utah, and
South San Francisco, California, while maintaining our current
laboratories in those locations.
- For the nine months ended September 30, 2024, additional rent
as a result of the build-out of our new laboratories in Salt Lake
City, Utah, and South Francisco, California, while maintaining our
current laboratories in those locations and testing and set-up
costs for equipment in our new facilities, lease terminations
gains, net of lease termination losses, impairment charges and
other abandonment costs.
- For the nine months ended September 30, 2023, accelerated
depreciation in connection with our decision to cease the use of
our former corporate headquarters in Salt Lake City, Utah, and
additional rent as a result of the build-out of our new
laboratories in Salt Lake City, Utah, and South San Francisco,
California, while maintaining our current laboratories in those
locations.
- Transformation initiatives – costs related to transformation
initiatives including:
- For the three and nine months ended September 30, 2024,
consulting and professional fees.
- For the three and nine months ended September 30, 2023,
consulting and professional fees and severance costs related to
restructuring.
- Legal charges, net of insurance reimbursement – one-time legal
expenses, net of insurance reimbursement. With respect to the
adjusted free cash flow reconciliation, the cash flow effect
includes cash paid for settlements in the related period.
- Tax adjustments – tax expense (benefit) due to non-GAAP
adjustments, differences between stock compensation recorded for
book purposes as compared to the allowable tax deductions, and
valuation allowance recognized against federal and state deferred
tax assets in the United States.
- As of September 30, 2024, a valuation allowance of $63.1
million was not recognized for non-GAAP purposes given our
historical and forecasted positive earnings performance.
- As of September 30, 2023, a valuation allowance of $47.3
million was not recognized for non-GAAP purposes given our
historical and forecasted positive earnings performance.
- For purposes of adjusted EBITDA, the income tax expense
adjustment includes the income tax expense (benefit) recognized in
the financial statements.
- Depreciation expense - depreciation expense recognized on our
fixed assets.
- Contingent consideration payment – for the nine months ended
September 30, 2024, the payment of contingent consideration related
to the previous acquisition of Sividon Diagnostics GmbH.
- Other adjustments – other one-time non-recurring expenses
including:
- For the three months ended September 30, 2024, changes in
severance and other consulting costs.
- For the three months ended September 30, 2023, primarily
includes changes in the fair value of contingent consideration
related to acquisitions from prior years and the reclassifications
of cumulative translation adjustments to income upon liquidation of
an investment in a foreign entity.
- For the nine months ended September 30, 2024, primarily
includes a gain recognized on acquisition, changes in the fair
value of contingent consideration related to acquisitions from
prior years, the reclassifications of cumulative translation
adjustments to income upon liquidation of an investment in a
foreign entity, severance, and costs incurred in connection with
executive personnel changes.
- For the nine months ended September 30, 2023, changes in the
fair value of contingent consideration related to acquisitions from
prior years, the reclassifications of cumulative translation
adjustments to income upon liquidation of an investment in a
foreign entity, and consulting and professional fees related to
prior year acquisitions.
- For purposes of adjusted EBITDA, other adjustments include the
items listed above as well as amounts included in other
income/expense in the financial statements.
|
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|
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Media
Contact: |
Glenn
Farrell |
Investor
Contact: |
Matt
Scalo |
|
(385) 318-3718 |
|
(801) 584-3532 |
|
PR@myriad.com |
|
matt.scalo@myriad.com |
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