Q1-2023 Letter to Stockholders
Letter to Stockholders
Dear Harrow Stockholders:
I am pleased to report that the Harrow team delivered record revenues of
Based on our results to date, we are reaffirming our 2023 guidance of
This year, we also have made significant progress elevating Harrow into a leading position among top-tier
- The successful launch of IHEEZO™, following the issuances of a permanentJ-Code(J2403) and transitional pass-throughreimbursement status.
o IHEEZO was officially launched at the recentAmerican Society of Cataract and Refractive Surgery ("ASCRS") Annual Meeting inSan Diego , where it was well received by leading eyecare professionals in attendance. - The closing of the "Fab Five" acquisition of
U.S. commercial rights to ILEVRO®, NEVANAC®, MAXIDEX®, VIGAMOX®, and TRIESENCE® (collectively, the "Fab Five Products").
o Harrow recently announced the transfer of the new drug applications ("NDAs") for ILEVRO, NEVANAC, and MAXIDEX, and we expect to transfer the NDAs for VIGAMOX and TRIESENCE later this year. - At the close of the first quarter, weannounceda new
$100 million secured credit facility withOaktree Capital Management , which was initially used to pay off a secured loan with an affiliate ofB. Riley Financial, Inc. , and will be further used to support the remaining milestone payment that will be due at the time TRIESENCE becomes commercially available. - We recently signed an agreement with a large health insurance carrier, including its national vision care network of patients and providers, to make available several of our chronic care CPPs on a cash-pay basis. See Page 4 for additional color on this big potential win.
Now let's take a look at the results for the first quarter of 2023.
First Quarter 2023 Financial Highlights and Commentary
Revenues of
1
As we had previously promised, we achieved these record revenues with no revenues from (a) our non-ophthalmic assets (which we sold in early
Core gross margin was 76% in the first quarter of 2023 compared with core gross margin of 75% in the first quarter of 2022.
Selling, general and administrative (SG&A) expenses for the first quarter of 2023 were
Research and development costs were
GAAP operating income was
Adjusted EBITDA was
Core diluted net loss per share for the first quarter of 2023 was (
We had
A reconciliation of all non-GAAP financial measures in this letter begins on page 9.
Selected highlights regarding GAAP operating results for the three months ended
For the Three Months Ended
2023 |
2022 |
|||||||||
Total revenues |
$ |
26,103,000 |
$ |
22,120,000 |
||||||
Cost of sales |
8,271,000 |
5,963,000 |
||||||||
Gross profit |
17,832,000 |
16,157,000 |
||||||||
Selling, general and administrative |
15,888,000 |
13,398,000 |
||||||||
Research and development |
734,000 |
658,000 |
||||||||
Total operating expenses |
16,622,000 |
14,056,000 |
||||||||
Income from operations |
1,210,000 |
2,101,000 |
||||||||
Total other expense, net |
8,141,000 |
4,539,000 |
||||||||
Income tax benefit |
288,000 |
- |
||||||||
Total net loss |
$ |
(6,643,000) |
$ |
(2,438,000) |
||||||
Net loss per share of common stock, basic and diluted |
$ |
(0.22) |
$ |
(0.09) |
||||||
2 |
In 2022, we began providing additional non-GAAP financial metrics - Core Results, which we define as the after-tax earnings and other operational and financial metrics generated from our principal business.
For the Three Months Ended
2023 |
2022 |
|
Net revenues |
|
|
Gross margin |
68% |
73% |
Core gross margin(1) |
76% |
75% |
Net loss |
(6,643,000) |
(2,438,000) |
Core net (loss) income(1) |
(1,042,000) |
713,000 |
Adjusted EBITDA(1) |
5,342,000 |
4,940,000 |
Basic and diluted net loss per share |
(0.22) |
(0.09) |
Core basic and diluted net (loss) income per share(1): |
(0.03) |
0.03 |
- Core gross margin, core net (loss) income, core basic and diluted net (loss) income per share (collectively, "Core Results"), and Adjusted EBITDA are non-GAAP measures. For additional information, including a reconciliation of such Core Results and Adjusted EBITDA to the most directly comparable measures presented in accordance with GAAP, see the explanation of non-GAAP measures and reconciliation tables at the endof this Letter to Stockholders.
IHEEZO, ASCRS 2023, and More
IHEEZO
This year's ASCRS Meeting included the formal launch of IHEEZO. In my experience, the most important factor in the success of an ophthalmic product launch is whether the product performs for the patient, the surgeon, and the surgical staff. If a product doesn't provide unique and meaningful value for every one of these constituencies, roadblocks to adoption will exist, growth will flag, and once launched, it's hard to recover.
Here is what we know so far about IHEEZO:
- All reports from IHEEZO customers to date have described clinical outcomes that mirror those that were reported in the clinical studies that supported IHEEZO's NDA.
- Surgeons and ophthalmic anesthesia providers who use IHEEZO are realizing what we learned when we did our market research years ago - that the idiosyncratic use of different anesthetic products, numerous instillation processes during various time intervals, and other related protocols to anesthetize the eye, create practice inefficiencies, and that there is a compelling need for a single agent to reliably anesthetize the eye - to "unify" the ophthalmic anesthetic protocol.
- Early adopters, and their staff, appreciate the ease of IHEEZO's use in the clinic and surgical suite - the way it seamlessly fits into their workflow.
- A single dose of IHEEZO (minimally, three drops) -and IHEEZO alone - has been reported to be sufficient, for example, to provide ocular surface anesthesia for cataract surgeries and intravitreal injections - once again, simplifying their anesthesia protocol and workflow.
- While I believed IHEEZO would be used primarily for cataract surgery and intravitreal injection anesthesia, several ophthalmologists I spoke to have other potential uses for IHEEZO, including anesthesia for other surgical and in-office interventions (e.g., photorefractive keratectomy ("PRK"), glaucoma surgeries, and laser procedures such as the yttrium aluminum garnet capsulotomy (or "YAG").
I am sure Harrow stockholders want to know how IHEEZO sales are looking. In fact, we are now recording sales of IHEEZO, and so far, we are confident that we remain on track to meet or exceed current revenue expectations for the year. I want to say more, but we are very early in the launch, and we still have market access work to do to optimize the potential for IHEEZO. Just know that, so far, we appear to be in good shape.
3
The Fab Five Products
By transferring the NDAs ahead of schedule for ILEVRO, NEVANAC, and MAXIDEX, we were able to begin marketing and selling efforts for those products at the ASCRS meeting. Customers we met with at ASCRS were pleased to see us support these important products and revitalize them under the Harrow name.
We still have a few additional pieces of the Fab Five transaction puzzle to implement. As an example, we believe the VIGAMOX NDA should transfer sometime this summer, and once this occurs, we will reveal more information about our VIGAMOX strategy - which our commercial team is excited about. We also continue to believe that TRIESENCE should be back in stock through our distributor partners later this year and that soon thereafter, the TRIESENCE NDA will transfer.
My takeaway from customer feedback at ASCRS aligned with our internal market research for all of the Fab Five products, especially TRIESENCE, reinforcing our belief that we purchased the right products, paid the right price, and that the Fab Five products will beautifully complement our ophthalmic pharmaceutical portfolio, expand our customer base, and drive further revenue and profit growth for many years to come.
ImprimisRx (CPPs or
I remain highly enthusiastic about our ImprimisRx CPP business. As many of you know, we have historically seen double-digityear-over-year revenue growth in our ophthalmic CPP business. We expect that growth trend to continue and that ImprimisRx will remain the dominant player in the
Innovative product development alone is insufficient to fuel my enthusiasm. I want to see positive market reception such as what occurred at ASCRS when Dr.
Another justification for my enthusiasm for our ImprimisRx CPP business is this:
Given the trend of increasing patient out-of-pocket costs for many medicines, we have been working hard for many years to partner with insurance carriers to make our cash-pay CPPs available to their prescriber networks and patients. Breaking into the insurance market with cash-pay CPPs has been tough for many reasons I won't expound on, but our drought with major insurance players is now over …
We recently signed a vendor contract with a very large health insurer, which includes one of the nation's largest vision care networks. Under this agreement, which kicks off on
4
Investments and Royalties
Harrow has non-controlling equity positions in three companies that were founded as Harrow subsidiaries before being deconsolidated into independent and separately managed companies.
Our largest interest is in
We continue to remain excited about being a large shareholder of both
Fulfilling our Mission
In my last Letter to Stockholders, I explained how your support of Harrow also supports our corporate mission of helping patients manage the preservation of their sight by providing access to innovative and affordable medicine and services.
I wanted to give you a quick update as we recently received e-mails from two separate physicians about mission trips to
Senior Executive Equity Compensation
The success of Harrow is dependent on the "above-and-beyond" efforts of many folks, including
5
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