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ANI Pharmaceuticals Inc (ANIP -1.34%)
Q4 2019 Earnings Call
Feb 27, 2020, 10:30 a.m. ET


  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Good morning, everyone, and welcome to ANI's Fourth Quarter 2019 Earnings Call. [Operator Instructions] It is now my pleasure to turn today's program over to Mr. Arthur Przybyl. Please go ahead, sir.

Arthur S. Przybyl -- President and Chief Executive Officer

Thank you, Laurie. Good morning, everyone, and welcome to ANI's earnings conference call for the full year and fourth quarter 2019. My name is Art Przybyl, I'm the CEO. And joining me today is Stephen Carey, our Chief Financial Officer.

Before we begin, I want to refer everyone to the forward-looking statements language in this morning's press release and ask each of you to review it carefully as important context for this conference call. Discussions will also include certain financial measures that were not prepared in accordance with generally accepted accounting principles. Reconciliation of those non-GAAP financial measures can be found in our earnings release dated today.

ANI reported its full year 2019 net revenues of $206.5 million, adjusted non-GAAP gross profit of a $146.9 million or 71% of net revenues, and adjusted non-GAAP EBITDA of $83.2 million, or 40% of net revenues. Our 2019 net revenues increased by 2.5%, gross profit dollars increased by 9% and both are record amounts for ANI.

Our net revenues and gross profit on three of our generic products were significantly impacted by competitive price erosion in the third and fourth quarter of 2019. The resulting impact was an annual estimated decline of $21.7 million in net revenues, and an annual estimated decline of $21 million in gross profit. In 2020, we expect to offset the impact of these declines through the recent launch of Vancomycin Oral Solution and the subsequent January 2020 acquisition of Amerigen's marketed products and pipeline.

For 2020, we are providing midpoint net revenue guidance of $218 million, an increase of 6%, and adjusted non-GAAP EBITDA guidance of $83 million, the same number as compared to 2019. Our 2020 guidance does not include any effect from additional acquisitions, and does not include any effect from the potential launch of Cortrophin Gel. Steve will provide you with additional commentary on our financial results.

Much of the ANI's growth has been and will continue to be achieved through acquisitions. We recently acquired Amerigen's US assets for $52.5 million, which we funded entirely from cash on hand. The acquisition included 23 generic products, 12 products are currently commercialized and 11 products are pipeline drugs. The acquisition was immediately accretive to revenues and gross profit, and has since expanded our commercial generic drug portfolio to 47 products. Our generic pipeline now includes 118 products with a combined annual market size of $7 billion based on data from IQVIA.

Over the last several years, we've completed 15 generic drug deals for a total of $135 million. In 2019 alone, these deals contributed $96 million in generic drug revenues. Additionally, most of our branded revenues have been acquired in eight deals for a total of $181 million, not including the $75 million for Cortrophin Gel, our largest pipeline opportunity, which is rapidly approaching its targeted regulatory filing date.

From 2015 to 2019, the cumulative branded revenues from these deals has been approximately $260 million, yielding gross margins of better than 90% with minimal SG&A expense. As an important part of our strategy, ANI intends to continue to acquire assets from time to time. However, the current environment for generic drugs such as solid oral drugs that are sold through three consortiums, who control 90% market share, remains highly volatile.

In addition to simply having too many generic manufacturers chasing too few customers, the industry is littered with companies that are over-levered and undercapitalized, leading to desperation in the marketplace that unduly pressures generic profit margins more than ever before. Consolidation within the generic drug industry must happen before real pricing stability can be achieved among those companies doing business with the three consortiums.

ANI will continue to explore tuck-in acquisition opportunities in this space that meet our strategic and evaluation criteria. Nonetheless, as a result of the highly competitive generic market created by the three consortiums, ANI also intends to pivot and explore acquisition opportunities in areas such as injectables and specialty drugs that can provide growth -- both growth opportunities and risk diversification for our business model. In other words, drug products that are not sold through these three consortiums. You have seen us pursue this strategy over the past year, as we have expanded our injectable pipeline, launched Vancomycin Oral Solution, a long-term care and hospital product, and launched Bretylium Injection, a critical hospital drug. Our biggest opportunity in this effort is, of course, Cortrophin Gel.

We are now approximately 30 days away from filing a supplemental NDA known as a Prior Approval Supplement, or PAS, for our Cortrophin Gel drug product. This has been our targeted filing date for some time now and all activities continue to advance as planned. Recall that Cortrophin Gel is an already approved NDA, last marketed in 1990s, that requires a Prior Approval Supplement by the FDA in order to recommercialize the drug. The supplemental NDA regulatory filing is the result of approximately four years of development and investment of over $100 million, $75 million to acquire the NDA and over $25 million to advance the drug to filing.

The result of our development effort is a PAS filing that includes 36 analytical methods employed to characterize commercial scale batches of Corticotropin active pharmaceutical ingredient. Several methods were validated from the approved NDA and the new methods were employed as part of the modernization process to demonstrate an unparalleled in-depth understanding of the quality and purity of ANI's Corticotropin active pharmaceutical ingredient.

Another major component of the modernization effort was viral clearance validation, which was not required when this product was originally approved. ANI's Corticotropin API manufacturing process has successfully completed viral clearance validation. Corticotropin active pharmaceutical ingredient is known to be a complex mixture of peptides, primarily ACTH 1-39. ANI has completed peptide mapping to identify the related peptides presence at greater than 0.1% in all process validation batches.

The results demonstrate consistent peptide levels in all three commercial scale process validation batches, and indicate a manufacturing process that is well controlled and consistent. All commercial scale batches of Corticotropin API have consistently met both the historical NDA specifications, and also the new modernized API specifications. Results from these methods for all commercial scale API batches have been assembled in a comprehensive API characterization package that ANI intends to file with PAS.

The supply chain for Cortrophin Gel from the slaughterhouse harvesting pig pituitaries to the manufacturer of active pharmaceutical ingredient and finished dosage foreign product is entirely based in the United States, an intentional and integral part of our development effort. We have successfully manufactured three commercial scale process validation batches of finished doses for Cortrophin Gel. All commercial scale batches of Cortrophin Gel have consistently met both the historical NDA specifications and also the new modernized drug product specifications. Two of the commercial scale batches are stable at six months real time stability and have been analytically consistent with regards to quality and yield, and have met all release specifications. The third batch stability pull is today, and we expect this batch to yield results consistent with the other two batches.

Additionally, we have validated commercial drug product manufacturing by bracketing two batch sizes to facilitate flexibility in order to conserve API needs and manufacture only what is needed to meet market demand. Filter validation and media fill simulations have also been successfully completed. We remain on target to file the PAS in March 2020, and to address and meet the FDA briefing book comments from our type C [Phonetic] FDA meeting.

Commercial launch activities for Cortrophin Gel have already begun. In the third and fourth quarter of 2019, we began building inventory of both pig pituitaries and active pharmaceutical ingredient. And we invested $6.7 million against that effort. We will continue to invest in commercial launch inventory and estimate spending an additional $11.5 million in 2020 for pig pituitaries, API and finished dosage form Cortrophin Gel. This inventory investment will allow us the opportunity to effectively compete for 50% market share upon launch.

Our commercial launch strategy and business model for Cortrophin Gel will be in place and implemented before and at the time of FDA approval. For competitive reasons, we do not intend to publicly describe our launch plan, but continue to be on record that ANI will offer a substantial discount for Cortrophin Gel as compared to Acthar Gel market pricing. We strongly believe that the economics of drug pricing is an important dynamic that helps drive utilization and market share in today's pharmaceutical marketplace. As such, we continue to see the public outcry over the price of drugs, and more specifically, Acthar Gel.

As recently as February 2020, complaint was filed by Marietta, Georgia that used the words exorbitant and unconscionable to describe Acthar's price. And even went so far as to accuse Mallinckrodt of illegal kickbacks to doctors. Whether true or not, this complaint is representative of continued public sentiment toward drug pricing and in this instance, Acthar Gel.

In the past, we have heard that synthetic Corticotropin products could potentially compete against our Cortrophin Gel. We now know that the two companies who are advancing synthetic versions have abandoned their development efforts. In a recent Assertio press release, recall, they acquired the synthetic Synacthen product from Mallinckrodt in an FTC action, they announced they were abandoning their Synacthen development effort. This effectively leaves ANI with the only near-term opportunity to compete against Mallinckrodt's Acthar Gel as the drug did successfully back in the 1990s.

For ANI, Cortrophin Gel remains a transformational opportunity. Not only can we potentially save healthcare hundreds of millions of dollars, but Cortrophin Gel can also potentially provide outside returns to our shareholders and help advance our business model. We believe that once commercial, Cortrophin Gel has the potential to provide annuity-like revenues for ANI, because we believe that it is highly unlikely that a competitor could successfully commercialize a generic version.

I've described Cortrophin Gel as a potential $200 million free cash flow opportunity for ANI. Let's examine the effect of half that number, $100 million, which would approximate 20% to 25% market share after AIN's ascribed discounted market price. In addition to more than doubling our current free cash flow and likely our equity value, the incremental cash flow could be deployed in additional product development and business development activities to further broaden our commercial portfolio and leverage ANI's brand and generic infrastructure. Not too many pharmaceutical companies with ANI's current size and scale have the near-term opportunity like Cortrophin Gel. This is why we continue to describe our Cortrophin Gel opportunity as transformational.

Lastly, a well-deserved hearty congratulations to our dedicated Cortrophin Gel development and regulatory individuals for all their efforts in helping to advance this important drug back to the healthcare market. What a great job.

I will now turn the conference call over to our CFO, Stephen Carey, who will provide you with more details on our financial results.

Stephen P. Carey -- Vice President and Chief Financial Officer

Thank you, Art, and good morning to everyone on the line this morning. For the year ended December 31, 2019, ANI posted record net revenues, adjusted non-GAAP gross profit and adjusted gross margin. Annual net revenues were $206.5 million, up $5 million or 2.5% from prior year. Adjusted non-GAAP gross profit reached $146.9 million, up $12.7 million or 9% and adjusted non-GAAP gross margins were over 71%.

We generated $45.6 million of cash from operation and importantly, continued to invest significant levels of cash back into the business, while maintaining financial and balance sheet discipline. Adjusted non-GAAP EBITDA was off $1.2 million from prior year levels at $83.2 million, while adjusted EPS was down $0.01 at $5.06 per diluted share.

As of December 31 balance sheet date, we had $62.3 million of unrestricted cash, up $19.3 million from prior year and up $2.6 million from September. This balance is net of $20.9 million of business development closed during the year in support of expanding our future pipeline opportunities and $6.6 million of capital expenditures made in support of advancing the capabilities of our three manufacturing plants.

On December 1, we successfully refinanced the majority of our $118.75 million convertible debt by exercising our option to borrow $118 million pursuant to the delayed draw term loan feature in our $265 million senior secured credit facility. The Company experience no equity dilution related to the maturity of the convertible notes.

Total net debt as of the balance sheet date was reduced to $125.2 million, representing 1.5 times net leverage and 2.3 times gross leverage on a trailing 12-month basis. Looking forward, we expect to continue to reinvest our cash flow from operations in business development opportunities. In January of 2020, we used $52.5 million of cash from the balance sheet to acquire 12 currently commercialized and 11 pipeline opportunities from Amerigen. In addition, the $75 million revolver portion of our credit facility remains undrawn and provides us with flexibility in continuing to pursue further business development transactions in 2020.

During 2019, we invested approximately $10.5 million in Cortrophin-related research and development as we continue to progress toward our March 2020 supplemental NDA filing. In addition, we invested $6.7 million in pre-launch raw material and the API inventory, in order to ensure that we are ready to launch Cortrophin into the market shortly after FDA approval of our filing. We currently anticipate investing upwards of $11.5 million behind additional pre-launch inventory in 2020. Please recall, as discussed on our third quarter earnings call, that these pre-launch inventories represent goods that will be utilized in saleable commercial batches upon FDA approval.

Ordinarily, materials purchased for commercial sale would be capitalized as inventory. However, since we are dealing with a novel product that must clear the supplemental NDA regulatory pathway with the FDA, GAAP dictates that such expenditures cannot be capitalized and must be expensed when purchase. In order to shed transparency on the physical build of Cortrophin inventory, we have broken this activity out on a separate line item on the P&L and disclosed further information in footnote number 13 to our financial statements.

In addition to these Cortrophin-related activities, during 2019, we invested $9.2 million in generic research and development. We also continue to invest behind and integrate our ANI Canada subsidiary and manufacturing facility, completing three tech transfers of ANI product into the plan with a fourth nearing completion, and recently securing new third-party business for our contract manufacturing capabilities. These annual figures and accomplishments were achieved despite weathering significant fourth quarter competition against one of our most important generic franchises.

During the fourth quarter, we took significant price reduction and shelf stock adjustment in order to defend our share of EES against two competitors that launched within days of one another in early November. These actions coupled with continued volume declines in EEMT and Inderal LA led net revenue for the three months ended December 31, 2019, to be down $9.2 million or 16% from prior year to $48 million. Resulting gross profit declines led to fourth quarter adjusted non-GAAP EBITDA of $17.4 million, down $4.8 million from prior year and adjusted non-GAAP EPS of $1.08 per diluted share, down $0.24 from prior year.

In addition, during the fourth quarter, we decided to exit the methylphenidate ER market, driven by the fact that this market has become highly commoditized, leading to unattractive price dynamics. In addition, we voluntarily exited the generic [Indecipherable] market, due to industrywide FDA investigations of NDMA impurities found in the vast majority of drug product for this compound.

In conjunction with these actions, we recognized a $3.5 million P&L charge to reserve for all remaining inventory related to these products. We have added this back for the purposes of our non-GAAP measures. Excluding this charge, our fourth quarter cost of goods sold was $14.3 million or 30% of net revenues as compared to $20.1 million or 35% of revenues in the prior year period. These challenges occurred during a period in which we are building momentum behind our September 2019 launch of Vancomycin Oral Solution. This product provides an FDA-approved alternative to a market that is largely served by compounding pharmacies. It is not a typical AB-related generic launch. And therefore, we currently anticipate revenues to ramp up over time as we build market awareness and product adoption through our virtual marketing and awareness campaign.

In addition, in December, we launched Bretylium Tosylate Injection, our first marketed injectable product, which is used in emergency room settings. In conjunction with this product, we launched a campaign to reintroduce this life-saving therapy to healthcare providers, and hospital formulary decision makers. These products are prime examples of our increasingly diverse commercial product offering.

Turning our attention to 2020 guidance. It is important to know that our guidance is exclusive of Cortrophin revenues, and pre-launch sales and marketing expenses. While we firmly believe that Cortrophin has the potential to be the most meaningful product in the Company's history, the timing of FDA approval and uptake of demand is inherently uncertain. As such, 2020 guidance, as presented today, only reflects the remaining anticipated residual R&D spend, and the cost to continue to build pre-launch commercial inventories. We will continue to add back the build of commercial inventories, and we will begin to add back pre-launch sales and marketing expenses in our 2020 actual non-GAAP results.

Our 2020 net revenue guidance reflects the annualization of negative competitive impacts against three of our largest generic franchises. First, the loss of volume from a key customer of Ezetimibe-Simvastatin, which began around midyear 2019 and will annualize in 2020. Secondly, the aforementioned significant price reductions for the EES franchise which occurred in the fourth quarter of 2019. And third, recent competitive challenges to EEMT, which have resulted in the reduction of average price beginning in January of 2020. These declines as well as normal course annual volume declines in our brand business are expected to be more than offset by the addition of generic products acquired from Amerigen in January, continued uptake in the demand for Vancomycin Oral Solution and Bretylium, and organic generic pipeline launches.

Given these factors, we currently project net revenues to be between $213 million and $223 million, representing a 3% to 8% increase over 2019. Adjusted non-GAAP EBITDA is projected to be between $80 million and $86 million, or essentially flat as compared to the $83.2 million posted in 2019.

Inherent in this guidance are the following. In anticipation that non-GAAP gross margins will contract by approximately 5 points to 7 points from the 71% achieved in 2019, principally resulting from lower price and unfavorable product mix. A reduction in research and development spending, driven by the wind down of activity in our Cortrophin Gel recommercialization program. A portion of this reduction is anticipated to be reallocated toward generic pipeline opportunities. And finally, moderation of the growth in non-Cortrophin-related SG&A expense.

Resulted adjusted non-GAAP diluted earnings per share is projected to be between $4.46 and $4.86 per diluted share and reflects an anticipated effective income tax rate of 24% and approximately 12.1 million shares outstanding. Note that the year-over-year changes for our non-GAAP EPS metrics include the impact of additional cash interest resulting from the December 1 refinancing of our convertible debt, which carried a 3% cash coupon to bank debt for which we currently anticipate an all in rate of approximately 4.6%. This change is worth approximately $1.9 million after-tax or roughly $0.16 to the EPS calculation.

The longer-term benefit of this change in debt structure is to protect our shareholders from future potential equity dilution and to avoid the high upfront costs associated with convertible debt. The costs of which are not reflected in the coupon rate. In addition, our guidance ranges include a straight 24% effective income tax expense rate as compared to an actual tax benefit recorded in the 2019 actual results. When taking these two factors in combination with one another, it accounts for an over $0.50 per share bridge to the EPS calculations.

In summary, we exit 2019 with a focus on maximizing near-term Vancomycin OS and Bretylium opportunities, leveraging the recently acquired Amerigen generic portfolio, continuing to diversify our product offerings through ongoing business development, expanding the potential for our CMO business and ANI Pharmaceuticals Canada, and most importantly, gaining FDA approval for Cortrophin.

With this, I will turn the call back to our President and CEO, Art Przybyl.

Arthur S. Przybyl -- President and Chief Executive Officer

Thank you for that, Steve. Laurie, we will now open the conference call to questions.

Questions and Answers:


Thank you. [Operator Instructions] Your first question comes from Dana Flanders of Guggenheim.

Dana Flanders -- Guggenheim -- Analyst

Hi, thank you very much for the questions. I just had a couple quick ones, if I could. First, could you provide kind of the relative contribution of the Amerigen portfolio to guidance this year? Any context would be helpful. And kind of what the growth outlook for that portfolio is going forward?

Number two, just how do we -- how should we think about just the gross margin sustainability? I know it's ticking down this year to the mid-60% range. That's still relatively attractive margin profile versus generic peers. So just curious if the base is down enough, and you're launching enough valuable products that you can sustain that mid-60% gross margins.

And just the third one, I may have missed this. But how much inventory build are you planning for Cortrophin this year? I understand you're not including any revenue in guidance, but just curious how much demand you can meet if you are approved four months after filing? Thank you.

Arthur S. Przybyl -- President and Chief Executive Officer

So let me take the last question first. The inventory build for Cortrophin [Indecipherable] anticipate again spending another $11.5 million this year on top of the $6.7 million last year. So the most important part of the inventory for Cortrophin is really the stockpile of pig pituitaries and more importantly than that, the stockpile of active pharmaceutical ingredient.

We will have a stockpile of active pharmaceutical ingredient after the invest -- that total investment but that is very, very close to a 50% of the market. If you're -- if we're estimating that the market is 30,000 biles, we're going to be very close to being able to -- from our API stockpile, generate almost 15,000 biles of finished dosage form.

Your second question, the gross margin sustainability in the mid-60s. We think that's an accurate reflection of where our business is at this moment in time. We no longer have really, I'll say, top-heavy generic product contributors after the hits we took on those three products recently. And so we feel that that's really an accurate reflection of where the business is today ex any additional acquisitions etc.

And the last question, maybe on the portfolio of Amerigen. Steve, could you address that, please?

Stephen P. Carey -- Vice President and Chief Financial Officer

Yes, sure. Good morning, Dana, and thanks for the questions. Yes, we are not going to speak to the particular numbers for the Amerigen portfolio in the guidance. I think that would be a typical approach. I mean, we do anticipate a significant contribution from the Amerigen portfolio. And I would say, qualitatively, that that contribution is very much in keeping with what our expectations for the portfolio were when we purchased it. All of the transition plans to move the volume as it stood in the hands of Amerigen over to ANI contracts and customer contracts has gone very smoothly. And so we're quite pleased that -- with our expectations for that portfolio.

Dana Flanders -- Guggenheim -- Analyst

Okay, thank you very much.

Arthur S. Przybyl -- President and Chief Executive Officer

You're welcome, Dana.


Your next question comes from the line of Elliot Wilbur of Raymond James.

Elliot Wilbur -- Raymond James -- Analyst

Thanks. Good morning. First question for yourself, Art, regarding the upcoming Corticotropin filing. Likely be the last time we hear from you before you actually submit the application. So just a couple points of clarification. When you actually file, do you -- do they notify you of official acceptance and is that a 30-day timeline? And if so, is that something that you would press release?

Second part of the question, do you think the filing could or should qualify for potentially an expedited review? And last part here is, these types of applications generally seem to move through the agency much more smoothly, efficiently and expeditiously when they have attention from folks kind of outside the review division and other than the individual reviewer themselves? So maybe could you describe if there were any activities taking place that might become visible to us post that filling or ahead of the filing that suggests that this is going to be a high-priority endeavor for FDA?

Arthur S. Przybyl -- President and Chief Executive Officer

Thank you, Elliot, good morning. So I'll take the last part of your question first. In areas will there be activities outside of the filing? Yes, there will be. I think it's very -- your point is very well taken. It's very important that several government officials, both in the Senate and House of Representatives, as well as HHS, FDA, are cognizant of the fact that we have filed our supplemental to our approved Cortrophin Gel drug.

There's obviously, over the years, a significant amount of noise associated with the monopolistic approach and pricing approach of Acthar Gel. And so I think we would certainly provide notification to these government officials that there's an important filing in the FDA NDA division associated with our product and why it's important. So we certainly will have a letter writing campaign to respective officials that we think cannot influence approval, but nevertheless have an understanding this has arrived on their desk after four years.

You asked a little bit about the expedited review. This product is not eligible for an expedited review, it's already approved. This is why we will receive on the date of filing a four months PDUFA date. And so in theory, the product itself could be -- the supplemental could be approved within four months. We're not handicapping that but that is certainly a potential possibility. And as -- but as such, it's not eligible for expedited review. However, we -- it's very important to point out that we're in the NDA division. This is not a biosimilar. We're not in office of generic drugs. And typically, my perspective is that the NDA division is a more expeditious division than maybe the office of generic drugs for some of these complex type products.

And so I -- hopefully that answers the extent of your questions. If I miss something, let me know.

Elliot Wilbur -- Raymond James -- Analyst

Sure. No, just one follow-up point here. Is there actually a post-submission notification that the supplement [Indecipherable] for review?

Arthur S. Przybyl -- President and Chief Executive Officer

I forgot that. Very good point. So yes, there will be a notification approximately within 30 days that they have accepted our filing. We see this as kind of de rigueur and we see no reason why they wouldn't with the filing that we're submitting. Whether or not we -- this is sort of second nature, whether or not we issue a press release associated with the fact that they've accepted our filing is debatable. If -- I think we will internalize that and if we feel that that is important to do so, we certainly will. But again, we expect 100% that they will accept this filing.

Elliot Wilbur -- Raymond James -- Analyst

Okay. And just a couple financial questions for Steve and yourself, as well, Art. I am just thinking about numbers cadence over the balance -- over the course of the year. We expect, obviously, second half to be stronger than the first half. But maybe more specifically, would you think that by the time we get to the second half of the year that the incremental contribution from the Amerigen portfolio, the ramp in Vancomycin Oral Solution, and also the incremental benefit of Bretylium is effectively offsetting the negative impact that you've experienced on both EEMT and EES?

Arthur S. Przybyl -- President and Chief Executive Officer

Well, we certainly anticipate that. The effect of Amerigen on our business is, sake of argument, instantaneous. So on the day we bought it, we picked up their revenues and gross profit. Now we have subsequently launched some additional products from that Amerigen portfolio and, obviously, we didn't acquire Amerigen on January 1. But that's -- there's an immediate effect from Amerigen.

Vancomycin and Bretylium, as I think both Steve and I spoke to, is a constant bill. And so from Vancomycin Oral Solution -- and I'll give you the importance of that. From Vancomycin Oral Solution, we see a steady bill of scripts over time. And so we feel very good. We've sort of extrapolated out what that means. We feel very good about the forecasted annualized revenue number for that product.

And for Bretylium, Bretylium is going to take a little bit longer because Bretylium has been off the market for some time. We certainly believe that this is a critical care drug that should be on crash carts as it was in the past for all hospitals and emergency services. We have an opinion paper that will be -- that was authored actually by "the father of Bretylium" that it will be coming out shortly and that will help guide hospitals and PMT committees to understand the continued significance of the Bretylium. But that one's going to take a little bit longer. And so we have, quite frankly, a slower ramp on that product.

And Steve, is there anything you'd like to add to that at all?

Stephen P. Carey -- Vice President and Chief Financial Officer

No, I think that's spot, Art. And your -- and Elliot, to the lead in of your question I'd say also spot on. We currently anticipate the comps for the first and second quarter, obviously, more difficult. And then when you bake in the factors being described here, we would anticipate the third and fourth quarter to be reflective of growth.

Elliot Wilbur -- Raymond James -- Analyst

Okay. Two quick financial follow ups, Steve. With respect to adjusted EBITDA guidance. Obviously, most Cortrophin expenses are excluded from that. But I wasn't sure if in fact that excluded all potential expenses relating to launch, including some potential sales and marketing activities in the back half of the year.

And maybe just, if you could, provide a little bit of color in terms of what's happening in the branded business, the branded portfolio and the softness and a couple of the more established brand lines? Is it incremental generic competition, customer mix, just what the dynamics there are and kind of why you're seeing a little bit more pressure at the margin?

Stephen P. Carey -- Vice President and Chief Financial Officer

Sure. So...

Arthur S. Przybyl -- President and Chief Executive Officer

Steve, let me just [Indecipherable] question first and I'll like you first question. So Eli, our brands have primarily been acquired, and they have great margins and great cash flow. Over time they decline. They are mature brands. There have been generic versions of these drugs and many times we even launch an authorized generic ourselves against the brand. So, as you know, our brands have, sake of argument, 1% or less market share. So over time, you will see our brands decline.

And so, you might not have seen that in the past, but that is because we've done branded acquisitions that sort of cover up the declines on the existing brand sales. And those declines are driven by just more and more people going to generics, or maybe more and more payers continuing to refer pharmacies or to obviously, the fact that there's a generic version available. Nevertheless, brands for us still represent, again, significant revenues and margins and cash flows. And really, from an SG&A perspective, cost has nothing to service. It's very de minimis amount.

So we are still active in attempting to acquire mature brands where we can. And so those opportunities pop up from time to time. And as you know Rob is -- Rob Schrepfer is on top of those opportunities when they present themselves.

Steve, maybe you want to tackle the Cortrophin question?

Stephen P. Carey -- Vice President and Chief Financial Officer

Yes, sure thing. So I think we can think of the Cortrophin expenses, Elliot, probably in the three buckets. So the first is on the R&D expense side. So what we anticipate there is, certainly, on an annual basis a significant decline year-over-year in R&D spend, call it somewhere around the $6 million, $6-plus-million of annualized declines. And from a calendarization, the remaining spend that we anticipate will occur principally in the -- call it, the first quarter of this year. And so that'll be a little bit of an uplift in the back half of the year from an expense perspective. About half of those declines are reductions in spend. We currently anticipate reallocating toward the generic programs that we're running.

The second main bucket would be the pre-launch inventories that we spoke about in the prepared comments. And so we do project, call it, $11 million to $12 million of pre-launch inventory builds in 2020 as compared to the $6.7 million spent this year. And those expenditures we are adding back for non-GAAP purposes. Obviously under the premise that once this product is approved, those are -- that would be inventory, and typically wouldn't be hitting our P&L.

And then lastly is on the sales and marketing side. And the guidance figures we gave this morning do not include any significant sales and marketing spend in those numbers. It's kind of under the premise that we're not putting in sales figures, we're not putting in the sales and marketing spend either. And so, we should expect to see that as add back to our non-GAAP figures until we reach the point of launching the product.

Elliot Wilbur -- Raymond James -- Analyst

Okay. One last question for Art, strategic question. The Company has done a very, very good job over the years in terms of building the business through opportunistic acquisitions, about brand and generic products taking advantage of the distress and misery in the space. One of the areas you've talked about, though, for some time in terms of having a strong interest in is injectables. But sort of listening to the rhetoric from around the industry, that's also an area where quite a few companies still see that as a growth opportunity or growth sector and are actively looking for assets in the space. I'm just wondering, what do you think or what would you sort of highlight or characterize as the opportunities for ANI within the context of an industry that still sort of use injectables as an attractive area?

Arthur S. Przybyl -- President and Chief Executive Officer

So, it's a good question, Elliot. I mean, for us it's sort of a natural segue since, obviously, Cortrophin Gel will be our -- probably for -- maybe for a long, long time to come our largest injectable product as we anticipated, as we talk about annuity like revenues on the product. Our injectable opportunities, so far, have been more related in product development areas. So, we did a deal with Coeptis and picked up several injectable opportunities, again, as you mentioned, because maybe the need on the part of the seller for capital, etc.

And I think we see there are certainly opportunities out there for injectables, some commercialize, some development. And yes, we are very well aware that a lot of folks are chasing some of those opportunities. Some of those opportunities have been actually created by the government, to be frank, on 505(b)2s and the like. I think you've seen some of them on products like calcium gluconate that Fersenius has, I mean just absolutely ridiculous price associated with a product that is -- costs nothing to make. And so, those opportunities are still out there.

I think, Elliot, one way to look at us is to say, OK, we've always been a sort of nuts and bolts company. We've been very careful how we've built out the business model in generics and mature brands. We've been very careful how we spend our money. We've been very careful on our debt levels and leverage. But at the same time, the Company took a significant high risk, high reward opportunity, and we clumped [Phonetic] down $75 million for a bunch of papers. But those papers are now coming to fruition for us. And I think we are incredibly bullish on Cortrophin Gel and what it can do for the Company and our investors in the short term, and then obviously longer term into the future.

My point that I'm trying to make is, we have defined additional high risk, but high reward opportunities in our pipeline. And knowing that we can fund them and keep all our other levels where they are, we going to look for those, and they're out there. And we're certainly having discussions on some of them as we speak. And so we want -- because we want to have our pipeline have some additional high risk, high reward opportunities alongside all of, what we call, more of a tuck-in opportunities that sort of fuel our -- that has fueled our growth from the time we have been public since time today. And so that's the way we're looking at some of these scenarios going forward.

What's going to replace Cortrophin, now that [Indecipherable]. And obviously, Cortrophin revenues and cash flow gives us the opportunity to add some of those, as I just said, high risk, high reward opportunities to our business model. And I think it's really important for a company like us. We're not really -- we're described, Elliot, as a generic pharmaceutical company. What generic pharmaceutical company out there today has margins of 65% to 70% and throws 40% of its revenues down to its EBITDA line, and has available cash flow, and credit lines that aren't drawn available to them. I think you'd be hard pressed to find one.

And so, we want to continue to apply the same disciplines that we have over the last several years to forward looking opportunities, needless to say. And that's our intent. And so Rob is out there with his team every day looking for those things, and we'll find them. I feel -- I have a high degree of confidence from our president transactions that our future ones will also continue to bring value to our shareholder base.

Elliot Wilbur -- Raymond James -- Analyst


Arthur S. Przybyl -- President and Chief Executive Officer

Thank you, Elliot.


Your next question comes from the line of Brandon Folkes of Cantor Fitzgerald.

Brandon Folkes -- Cantor Fitzgerald -- Analyst

Hi. Thanks for taking my question. Maybe just following on that. Art, you mentioned that you believe that the generics industry need to continue to consolidate while pivoting toward the injectable drug and specialty drugs. If the opportunity presents itself, would you still grow your generics business through consolidation or should we think of business development going forward really focused on sort of the injectable and specialty [Speech Overlap]

Arthur S. Przybyl -- President and Chief Executive Officer

Brandon, thanks for that question. I think that we mentioned that we certainly will continue to look for tuck-in acquisitions. I think the key -- kind of the key numbers in regards to our generic acquisitions that we've done is that we've done 15 for total of $135 million. And from those transactions just in 2019, those transaction contributed $96 million in revenues at, obviously, very nice margins. And so we wouldn't stop with that. But we've always been a value type of buyer. And today's marketplace for these acquisitions, it's still vibrant.

There are just -- there are so many companies that are strapped for cash. There are many companies -- generics has always been an entrepreneurial type business in '14 and '15 when the generic market was flying high and people thought prices were going up forever. A lot of smaller entrepreneurial companies cropped up and started. And people -- entrepreneurs did development on products the traditional way. And now they're getting approvals, but they're a little bit short on cash to launch some of these drugs. We see it all the time. And it cost just as much money, if not more, to launch drugs, inventory builds and obviously, waiting for your receivable dollars from the wholesalers than it does maybe than to develop the drug. And so that's where some of our opportunities lie.

So we will certainly -- we won't turn the blind eye to a good value or a good acquisition opportunity for our shareholders, which is why I mentioned that we'd still look for these tucking opportunities. However, it is very important for us to -- without question diversify away from just doing the primary bulk of our business with the three consortiums. Now we're going to do that, obviously, to Cortrophin Gel. And the three consortiums are not going to have the same level of purchasing power over our business model than they do today because of that one drug. But we think more and more drugs need to contribute to that effect as well.

We just need to be more -- have a greater diversified platform because the one thing we can't -- I was talking to investor earlier this morning and they were dismayed. They thought that we were just going to buy the Amerigen products, add it to our ascribed EBITDA run rate and that would be our new run rate essentially for the New Year. Well, so did we. And by that, I mean, we never know in the oral solid space with the three consortiums where competition is coming from. And when it hits, it hits hard.

So if you all of a sudden have a very nicely running gross margin product like we did at EES for three years and we get two competitors, price drops 50% overnight. And there's nothing you can do to backstop that, but an attempt to maintain your market share and drop your price and have enough products to launch to offset that. And we were fortunate, we've been able to do that so that our EBITDA run rate is certainly right where it was last year. It is still representative of throwing off 40% from our revenue line, that's powerful. And so that's great, for us, these acquisitions mean a lot to us. But the fact is, we just don't know where competition is coming from at any point in time.

So diversification across different business platforms within the generic industry is important to us, and so are opportunities like 505(b)2s etc. So where to scale now as a company and the fact that we've spent our money, sake of argument, just a lot of our money in Cortrophin development, that allows us to pivot to some of these other areas as well.

And fortunately, we've got the cash flow and the liquidity to allow us to do so. That's why I think we're in excellent shape. These types of quarters, there are moments in time, they are 90 days in duration, but they don't represent the long-term potential for our business. And so we are -- we, as a management team, feel very confident in our approach to this marketplace going forward, obviously.

Brandon Folkes -- Cantor Fitzgerald -- Analyst

Great, thanks so much.

Arthur S. Przybyl -- President and Chief Executive Officer

Moderator, if there's no other questions, I just like to thank everybody for attending ANI's 2019 earnings conference call and wish you all a good afternoon. Thank you very much. Bye-bye.

Stephen P. Carey -- Vice President and Chief Financial Officer

Thank you.


[Operator Closing Remarks]

Duration: 57 minutes

Call participants:

Arthur S. Przybyl -- President and Chief Executive Officer

Stephen P. Carey -- Vice President and Chief Financial Officer

Dana Flanders -- Guggenheim -- Analyst

Elliot Wilbur -- Raymond James -- Analyst

Brandon Folkes -- Cantor Fitzgerald -- Analyst

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